BIGNOPE
Ko-fi

Recalls affecting Kentucky

Data last updated: September 10, 2026 at 1:16 PM UTC

16,694 recalls found

Just announced

Straight from FDA press releases — not yet formally classified or risk-graded
UnclassifiedUndeclaredAnnounced September 4, 2026

Business Pill, Branch Manager for Mendietary supplements marketed for male sexual enhancement

Products contain undeclared yohimbine

Full report
Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

Grant-Valkaria, Florida - SUPPLX.com is voluntarily recalling Business Pill and Branch Manager for Men, products marketed as dietary supplements for male sexual enhancement, because FDA laboratory analysis confirmed that both products contain yohimbine that is not declared on the product labels.

Company contact: (321) 341-9501 · SupplxRecall@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaAnnounced September 4, 2026

Foods AliveMoringa Leaf Powder

Potential to be contaminated with Salmonella

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

Foods Alive Inc of Angola, IN, is recalling its 8-ounce packages of organic moringa leaf powder because they have the potential to be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced September 3, 2026

B. Braun0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container

Presence of particulate matter identified as iron oxide

Full report
Drugs

Recalling firm: B. Braun Medical Inc.

“On September 3, 2026 firm updated their press release to include additional contaminants.” FOR IMMEDIATE RELEASE – September 3, 2026– Bethlehem, PA, B. Braun Medical Inc (B. Braun) is voluntarily recalling three (3) lots of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container, to the hospital/healthcare facility/user level due to presence of particulate matter identified as iron…

Company contact: recalls@bbraunusa.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusE. coliAnnounced September 3, 2026

Great ValueOrganic Triple Berry Blend

Possible E. Coli Contamination

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Frutas y Hortalizas del Sur S.A.

September 02, 2026. Frutas y Hortalizas del Sur S.A., San Carlos, Chile expands its July 3, 2026, recall of frozen organic IQF blueberries to include one lot of Great Value frozen Organic Triple Berry Blend 10 OZ because of potential contamination with Escherichia coli O145:H28 (E. coli O145) .

Company contact: Info.foodsafety@comfrut.com

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced September 3, 2026

American Regent, Inc.Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vial

Presence of particulate matter and lack of sterility assurance

Full report
Food & Beverages

Recalling firm: American Regent, Inc.

FOR IMMEDIATE RELEASE – September 3, 2026 – New Albany, OH, American Regent, Inc. is conducting a nationwide voluntary recall of three lots of Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vials to the consumer level. Customer complaints were received for leaking and cracked vials, resulting in lack of assurance of sterility.

View FDA’s announcement (opens in a new tab)
UnclassifiedAllergenMilkUndeclaredAnnounced August 31, 2026

Little TemptationsChocolatey Eyeballs, 7 oz., 10 oz., 10.5 oz., 11 oz., and 16 oz.

Undeclared milk

Full report
Food & BeveragesAllergens

Recalling firm: Crystal Temptations

Crystal Temptations of North Arlington, NJ is recalling Halloween Chocolatey Eyeballs because they contain undeclared MILK allergens. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

View FDA’s announcement (opens in a new tab)
UnclassifiedUndeclaredAnnounced August 31, 2026

LipofitLipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

Full report
Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

FOR IMMEDIATE RELEASE - August 27, 2026 - Davie, Florida – Ana Salazar Modela Tu Cuerpo Inc. is recalling Lipofit Extreme Fat Burner 2.0, Lot 25M12F, expiration date 09/2027, to the consumer level.

Company contact: (954) 305-1004 · yandrydy@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced August 31, 2026

KofinasGarlic Mediterranean Infused Extra Virgin Olive Oil 500 ml, 250 ml, and 100 ml

Contains garlic essential oil not approved for culinary use

Full report
Food & BeveragesIngredients

Recalling firm: LMSI LLC

Cincinnati, OH (Aug. 29, 2026) - LMSI LLC/ Kofinas Olive Oil is issuing a voluntary recall of its Garlic Mediterranean infused extra virgin olive oil for using a garlic essential oil not approved for culinary use. The flavored oil was bottled in glass bottles in 500 ml, 250 ml, and 100 ml sizes.

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaE. coliAnnounced August 29, 2026

Everything SproutsRobust Radish Mix, 5oz Cups

Potential to be contaminated with Shiga toxin-producing Escherichia coli (STEC) or Salmonella.

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

Everything Sprouts, LLC, based in Minneapolis, MN is expanding its voluntary recall of sprouts to include certain lots of Robust Radish Sprout Mix because it has the potential to be contaminated with Shiga toxin producing Escherichia coli (STEC) or Salmonella bacteria.

Company contact: everythingsproutsmn@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaAnnounced August 29, 2026

MartinaMangoes

Potential contamination with Salmonella

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

MAMARONECK, NY, AUG. 28, 2026 - Panorama Produce is recalling 302 boxes of size 9 (nine) mangoes because they may be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2026

NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027; 2. SYRINGE,10ML,TR/FR,RA,W/RES, Medline SKU 70085007; 3. MTO,SYRINGE,10ML,TR/FG,RA,-,PKG, Medline SKU 70085107; 4. SYRINGE,12ML,TR/FR,RA,W/RES, Medline SKU 70087007; 5. MTO,SYRINGE,12ML,TR/FG,RA,W/RES, Medline SKU 70087107; 6. SYRINGE,12ML,TR/FR,RA,W/O,RES,-,PKG, Medline SKU 70088007; 7. SYRINGE,10ML,PP/FR,RA,-,PKG, Medline SKU 70095007; 8. SYRINGE,10ML,PP/FG,RA,-,PKG, Medline SKU 70095107; 9. SYRINGE,12ML,W/RES,PP/FR,RA,PG, Medline SKU 70097007; 10. SYRINGE,12ML,PP/FG,RA,W/RES,-,PKG, Medline SKU 70097107; 11. SYRINGE,12ML,PP/FG,RA,W/O,RES, Medline SKU 70098107; 12. SYRINGE,20ML,TR/FR,RA,OEM,PG, Medline SKU 80075027; 13. SYRINGE,10ML,ANGIO,W/RA,-,OEM, Medline SKU 80085007; 14. SYRINGE,12ML,TR/FR,RA,OEM, Medline SKU 80087007; 15. SYRINGE,10ML,PP/FR,RA,-,OEM,-,PG, Medline SKU 80095007; 16. SYRINGE,10ML,PP/FG,RA,OEM,PG, Medline SKU 80095107; 17. SYRINGE,12ML,PP/FG,RA,-,OEM,-,PG, Medline SKU 80097107

Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98598
Lot/product code:
Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000073035; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000075896; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000078648; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000082387; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000082384; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000087087; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000093180; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000093741; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000095735; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000102248; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000102694; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000105537; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000107947; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000113756; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000117610; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000118566; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000122251; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000124476; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000126969; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000131544; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000134543; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000139258; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000140972; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000141871; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000148316; Medline SKU # 60010034, UDI/DI each 10193489087246, UDI/DI case 20193489087243, Lot Number: 0000071568; Medline SKU # 60010034, UDI/DI each 10193489087246, UDI/DI case 20193489087243, Lot Number: 0000081594; Medline SKU # 60010102, UDI/DI each 10193489040197, UDI/DI case 10193489087246, Lot Number: 0000078094; Medline SKU # 60010102, UDI/DI each 10193489040197, UDI/DI case 10193489087246, Lot Number: 0000090667; Medline SKU # 60010102, UDI/DI each 10193489040197, UDI/DI case 10193489087246, Lot Number: 0000100891; Medline SKU # 60010102, UDI/DI each 10193489040197, UDI/DI case 10193489087246, Lot Number: 0000102756; Medline SKU # 60010102, UDI/DI each 10193489040197, UDI/DI case 10193489087246, Lot Number: 0000106009; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000070691; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000074251; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000076643; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000079468; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000083282; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000086207; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000087266; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000090244; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000093925; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000096371; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000098671; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000104426; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000109080; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000112855; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214,… (truncated, 1290865 characters total — see the official FDA record for the full value)
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2026

Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTIVE Pro Laser System TFL-SLS Model/Catalog Number: TFL-SLS containing TFL-CSLU Product Description: An electricity powered device assembly which emits a high-power laser beam to vaporize/ablate soft tissue with moderate hemostasis, little charring, and a thin zone of necrosis. Component: No

Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable. Additionally, smoke or a burning smell may occur. By design, the issue causing the smoke or burning smell would be contained within the internal laser console enclosure and would be self-extinguishing.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98422
Lot/product code:
Laser System: TFL-SLS; UDI: 00821925044135; Component Part: TFL-CSLU; UDI: 00821925044593; Serial #: MDUF190114, MDUF220073, MDUF220331, MDUF220353, MDUF220354, MDUF220356, MDUF220411, MDUF220412, MDUF220413, MDUF220414, MDUF220427, MDUF220451, MDUF220453, MDUF220454, MDUF220455, MDUF220456, MDUF230004, MDUF230005, MDUF230006, MDUF230007, MDUF230076, MDUF230140, MDUF230141, MDUF230163, MDUF230164, MDUF230166, MDUF230167, MDUF230234, MDUF230283, MDUF230284, MDUF230331, MDUF230332, MDUF230361, MDUF230362, MDUF230363, MDUF230364, MDUF230365, MDUF230366, MDUF230411, MDUF230412, MDUF230413;
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2026

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes TAVR PACK DYNJ69246B ABDOMINAL VASCULAR-LF DYNJ905291D ANGIOGRAPHIC PACK DYNJ86769 AORTAGRAM PACK DYNJ26783D AV FISTULA PACK CHS-LF DYNJ35615G AV SHUNT PACK-LF DYNJ0842516G CATHETER PACK DYNJ61926 EP DRAPE PACK-LF DYNJ47645C EP PACK DYNJ47782G EPS ACCESSORY PACK DYNJT2201S H CLINIC VASCULAR PK DYNJ33415A HEART FAILURE PACK DYNJ64877B HYBRID PACK DYNJ65925D INTERVENTIONAL RAD PACK DYNJ44100M INTERVENTIONAL RADIOLOGY PK-LF DYNJ0516014AG MV-PACEMAKER PACK-LF DYNJ41556F NEURO RADIOLOGY RICHMOND DYNJ68365D OR HYBRID-M DYNJ907758D, DYNJ907758F PACEMAKER DYNJ907960C PACEMAKER PACK DYNJ42557B DYNJ61411 DYNJ61411A DYNJ61411B DYNJ80160 PACER PACK DYNJ40952B PERIPHERAL ARTERIOGRAM RAD DYNJ61383B RADIOLOGY PACK DYNJ54762D TAVR PACK DYNJ55338B DYNJ69246A VASCULAR ACCESS TRAY DYNJ52606F VASCULAR TRAY DYNJ49802C VEIN PACK DYNJ57512 DYNJ58063 DYNJ84953

Unapproved design changes to the products outside of the 510(k) clearance.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98601
Lot/product code:
DYNJ69246B UDI-DI 10198459335266 (EA) 40198459335267 (CS) LOT 25EBM356 DYNJ905291D UDI-DI 10195327393090 (EA) 40195327393091 (CS) LOTS 24JBO127 24LBJ199 DYNJ86769 UDI-DI 10195327674168 (EA) 40195327674169 (CS) LOT 24EMF716 DYNJ26783D UDI-DI 10193489616750 (EA) 40193489616751 (CS) LOTS 23DBJ248 23EBK921 23FBS130 23HBB516 23IBS065 23JBP123 23LBP196 24ABR004 24ABR121 24BBG855 24GBV377 24JBI914 24KBD153 24LBB665 DYNJ35615G UDI-DI 10195327099404 (EA) 40195327099405 (CS) LOT 23EBR748 DYNJ0842516G UDI-DI 10195327286392 (EA) 40195327286393 (CS) LOTS 24CDB991 24GDB891 24IDA796 24KDB683 DYNJ61926 UDI-DI 10193489610406 (EA) 40193489610407 (CS) LOTS 23CBK311 23DBM226 23FBP893 23GBN159 23HBC859 23JBH552 23LBV456 24DBM081 24EBS504 24FBR479 DYNJ47645C UDI-DI 10195327355173 (EA) 40195327355174 (CS) LOTS 23IMH312 23LMD467 24BMB620 24DMD512 24FMF757 24GMD538 24JMC369 24KMB831 24LMD945 DYNJ47782G UDI-DI 10195327495640 (EA) 40195327495641 (CS) LOT 24GMA622 DYNJT2201S UDI-DI 10195327263003 (EA) 40195327263004 (CS) LOT 23HMG629 DYNJ33415A UDI-DI 10888277792555 (EA) 40888277792556 (CS) LOT 24CBG963 DYNJ64877B UDI-DI 10193489415896 (EA) 40193489415897 (CS) LOTS 23CBF259 23HBM117 23HBO973 23KBD360 23LBG859 24ABB266 24CMJ034 24FMD963 24HMH185 24JMD105 DYNJ65925D UDI-DI 10195327531188 (EA) 40195327531189 (CS) LOT 24DLA029 DYNJ44100M UDI-DI 10195327324988 (EA) 40195327324989 (CS) LOTS 23IMG347 23JMI669 23LME170 24AMI085 24CMA877 24CMJ446 24DME309 24FMC387 24FMC900 24FMF012 24FMH007 24GMC363 24HMF632 24JMF664 24LMD487 DYNJ0516014AG UDI-DI 10195327271640 (EA) 40195327271641 (CS) LOTS 23BME190 23DMH005 23KMH805 23KMI253 23LMH275 24AMH347 24CMI868 24DMI402 24DMK427 24EMG633 24IMB650 24IMJ127 24KMC298 DYNJ41556F UDI-DI 10193489968170 (EA) 40193489968171 (CS) LOTS 23IME423 23IMH983 DYNJ68365D UDI-DI 10195327525040 (EA) 40195327525041 (CS) LOT 23JBH517 DYNJ907758D UDI-DI 10195327351335 (EA) 40195327351336 (CS) LOTS 23FBP055 23HBC362 23HBL227 23HBX060 23KBB106 24CBT278 24CBV291 24HBE808 24HBR182 DYNJ907758F UDI-DI 10198459128622 (EA) 40198459128623 (CS) LOTS 24JBM379 24KBC281 DYNJ907960C UDI-DI 10195327347451 (EA) 40195327347452 (CS) LOT 24CBT833 DYNJ42557B UDI-DI 10889942135806 (EA) 40889942135807 (CS) LOT 24BBA461 DYNJ61411 UDI-DI 10193489562705 (EA) 40193489562706 (CS) LOT 23GBH973 DYNJ61411A UDI-DI 10195327483234 (EA) 40195327483235 (CS) LOTS 23IBH456 23JBN809 DYNJ61411B UDI-DI 10195327628697 (EA) 40195327628698 (CS) LOTS 24DBE155 24LBE209 DYNJ80160 UDI-DI 10195327013226 (EA) 40195327013227 (CS) LOT 24CBJ103 DYNJ40952B UDI-DI 10195327203726 (EA) 40195327203727 (CS) LOTS 24EBT279 24GBQ711 24HBR555 24JBO326 24LBM313 DYNJ61383B UDI-DI 10193489751277 (EA) 40193489751278 (CS) LOTS 23FLA104 23HLA490 23ILB095 23KBP994 23LBD911 24ALA301 DYNJ54762D UDI-DI 10195327031725 (EA) 40195327031726 (CS) LOT 24ABX637 DYNJ55338B UDI-DI 10193489859027 (EA) 40193489859028 (CS) LOT 22GMG972 DYNJ69246A UDI-DI 10198459178931 (EA) 40198459178932 (CS) LOTS 24LBA791 25ABA813 25CBF356 25DBA846 DYNJ52606F UDI-DI 10193489343298 (EA) 40193489343299 (CS) LOTS 23ELB102 23GLA496 23HLB190 23JLA642 23JLB201 24BLA295 24DLA690 24FLA227 24GLA493 24HLA557 24ILA766 24KLA315 DYNJ49802C UDI-DI 10193489461602 (EA) 40193489461603 (CS) LOT 24BBD110 DYNJ57512 UDI-DI 10889942748273 (EA) 40889942748274 (CS) LOT 24ABS819 DYNJ58063 10889942816675 40889942816676 24ABM343 DYNJ84953 10195327440299 40195327440290 24FBM720 ***Updated 5/20/26 - The following lots were included in the customer notification but not the FDA submission.*** DYNJ0516014AG Lots 22LMD393 23DMG745 23HMB539 23LMH275A; DYNJ0842516G Lots 22KDA699 22LDC077 23DDB550 23GDA061 23HDC455 23JDA626 23LDB990 25BMH951 25BMI475; DYNJ26783D Lots 21CBL983 21FBE677 21GBR689 21JBA358 21KBF796 21LBG769 22ABX397 22CBA514 22FBK918 22GBO115 22JBU884 22KBJ430 23ABN303 23BBN053 25ABH287 25ABV765 25BBE142 25CBE875; DYNJ40952B Lots 22HBH043 22JBJ979 23DBR448 23FBE598 23JBL097 23KBH476 24ABR924 25BBS344 DYNJ44100M Lots 23AMJ315 23CMH807 23EMG216 23EMG763 23GMH722 23HMF163 23LMC066 25BMB884 25CMC633 25EMG169; DYNJ47645C Lots 23CMB852 23DMB824 23FMB662 25AMC532; DYNJ52606F Lots 21AKA467 21DKA121 21GLA734 21HLA612 21ILA348 21JLA304 21LLA164 22ALA074 22ALA885 22BLA931 22DLA955 22FLA562 22HLA294 22ILB142 22JLA807 23BLA662 23CLA943 25ALA106 25CLA447; DYNJ61383B Lots 21CLA367 21FLA054 21GLA195 21JLA060 21LLA062 22CLA063 22CLA337 22DLA685 22DLB071 22ELB118 22JLA236 22KLA964 23ALA936 23CLA512 23ELA390 23FLA461 23GLA377 23JLB155 23KLA301 23KLA89… (truncated, 5621 characters total — see the official FDA record for the full value)
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2026

Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1180100777

The outer packaging and blister pack labeling identify the product as 1mL Luer Lock Tuberculin Syringe (Product Code 1180100777), however the syringes contained within the packages are U-100 Insulin syringes.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98534
Lot/product code:
UDI/DI 10884521013414 (each), 20884521013411 (box), 30884521013418 (case), Lot Numbers: 531164X, 531162X
Recalling firm:
Cardinal Health 200, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2026

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes JUDKINS PACK DYNJ51126 ANGIO PACK DYNJ32555C, DYNJ66631 ANGIO TRAY DYNJ46153B ANGIOGRAPHY PACK DYNJ26855F ANGIOGRAPHY PACK-M-LF DYNJ24530I ANGIOGRAPHY TRAY-LF DYNJ0220880V, DYNJ30077D CATH LAB ANGIO PACK-LF DYNJ0545064X CATH LAB PACK DYNJ39057C FEMORAL ANGIOGRAPY SET UP DYNJ61015B RAD-ANGIO PACK DYNJ47710C SURGERY ANGIO PACK-LF PHS677784013A

Unapproved design changes to the products outside of the 510(k) clearance.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98601
Lot/product code:
DYNJ51126 UDI-DI 10889942122820 (EA) 40889942122821 (CS) LOT 20ADA585 DYNJ32555C UDI-DI 10193489859485 (EA) 40193489859486 (CS) LOTS 21HMF699 21IMF813 21JMA855 21KMD605 22DMB423 22FMD574 22HMB608 22LMA169 23BMA114 23EMB817 23EMG153 23KMB692 23KMH359 23LMH085 24AMC563 24CMD587 24DMD256 24DMG305 24FMD717 24IMI650 24JMC830 DYNJ66631 UDI-DI 10193489368321 (EA) 40193489368322 (CS) LOTS 22BBB494 22BBB497 DYNJ46153B UDI-DI 10193489853643 (EA) 40193489853644 (CS) LOTS 23EBM225 23FBC884 23HBP278 23IBV999 23KBC319 23LBK125 24CBF100 24DBE952 24FBP262 24GBN960 24HBO921 24IBO007 24IBU941 24JBK669 24LBK644 DYNJ26855F UDI-DI 10888277012042 (EA) 40888277012043 (CS) LOTS 20CBI049 20EBB600 20FBK900 20GBD331 20GBL795 20IBC788 20JBM786 20KBF148 21BBK244 21EBR327 21HBB849 21IBQ809 21OBA396 DYNJ24530I UDI- DI 10193489674910 (EA) 40193489674911 (CS) LOT 24ABU775 DYNJ0220880V UDI-DI 10889942054688 (EA) 40889942054689 (CS) LOTS 23HLA505 23HLB257 23JLA021 23JLA059 23KLA121 23KLA231 23KLA582 23LLA817 24ELA405 24ELA796 24HLA596 25AMI609 25BMH660 25CMA797 25DMF893 DYNJ30077D UDI-DI 10889942138630 (EA) 40889942138631 (CS) LOTS 23FBQ479 23LBL707 24CBC495 24EBQ346 24GBK895 24HBD023 24HBP290 24JBJ112 DYNJ0545064X UDI-DI 10193489747621 (EA) 40193489747622 (CS) LOTS 20BBL115 20CBA649 20DBB933 20DBP595 20HBW939 20KBI815 21ABK039 21ABK542 DYNJ39057C UDI-DI 10193489765519 (EA) 40193489765510 (CS) LOT 24BBD166 DYNJ61015B UDI-DI 10193489368888 (EA) 40193489368889 (CS) LOTS 23CMG023 23FBN151 DYNJ47710C UDI-DI 10889942214495 (EA) 40889942214496 (CS) LOTS 23FBF109 23GBB677 23JBP270 23LBO688 24DBD356 24FBP326 24IBC340 24KBJ788 PHS677784013A UDI-DI 10193489604337 (EA) 40193489604338 (CS) LOTS 20BBR301 20IMA683 21BMC467 21CMC052 21FMD140 21IMF229 22AMA959 22AME458 23GMA491 23GMD585 ***Updated 5/20/26 - The following lots were included in the customer notification but not in the FDA submission.*** DYNJ0220880V Lots 21DLA453 21FLA083 21ILA147 21KLA059 22ALA849 22DLA707 22FLA700 22HLA272 22ILA188 22ILA237 22ILA641 22JLA662 22KLA836 22KLA939 22LLA399 25KMB595 25LMA384; DYNJ30077D Lots 21ABB348 21ABR327 21DBQ397 21FBM873 21GBL539 21IBB390 21JBO220 21KBC302 21KBV079 21LBT528 22ABZ834 22DBD744 22EBG375 22JBK533 22KBO291 22OBM411 23ABD824 23ABO419 23DBB788 23EBS951 23HBB563 23IBG762 23JBT149 24CBR583; DYNJ32555C Lots 21DMA301 21DMD929 21EMB686 21FMA163 22KMD644 23AMB073 24LMH114 25BMA103 25BMD349; DYNJ46153B Lots 21CBL359 21FBE618 21GBF346 21HBQ716 21IBW154 21KBI853 21LBA401 22ABE877 22BBW978 22CBU323 22EBN725 22FBQ420 22GBJ229 22HBD581 22IBL258 22JBM061 22KBD440 22NBA199 23ABG769 23BBE724 25BBR850 25EBA187; DYNJ47710C Lots 21CBM120 21GBL622 21KBA849 21KBA925 22ABX239 22CBP654 22JBI023 22LBR933 23BBT611 25BBF414 25CBJ501; DYNJ61015B Lots 21AMB131 21BMB923 21BMC128 21CMD384 21DMD441 21FMD102 21GME205 21JMG652 22AMD050 22AME244 22DME869 22FMA872 22FMD246 22GMG534 22IMB779 22IMF574 22JMG963 23AMD815 23BMB886 23DMC707; DYNJ66631 Lots 21IBH359 21VBC892 22BBW852 22DBJ281 22EBJ532 22GBA380
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2026

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ADULT CATH PACK-LF DYNJ38395G ANGIO DRAPE PACK (ADLUG)642-LF DYNJ47665F DYNJ47665G ANGIO KIT PACK DYNJ83746 DYNJ83746A ANGIO PACK DYNJ30565G DYNJ51239C DYNJ66631A DYNJ69200A DYNJ88276 ANGIO PHC DYNJ37485D ANGIO TRAY 116118 DYNJ37724K ANGIO TRAY NO LIDO DYNJ85557 DYNJ85557B ANGIOGRAM-30852 DYNJVB91148A ANGIOGRAPHY DRAPE PACK-LF DYNJ0373221P ANGIOGRAPHY PACK DYNJ17218R DYNJ44293F DYNJ44293G DYNJ44293J DYNJ83516 ANGIOGRAPHY PACK-LF DYNJ0854485X ARTERIOGRAM DYNJ28082I BASIC HEART CATH PACK DYNJVB1075B CARDIAC CATH DYNJ910293 CARDIAC CATH PACK DYNJ68653B DYNJ68653C CARDIAC CATH PACK-LF DYNJ85258 CATH LAB (EP) PACK DYNJ65162B CATH LAB ANGIO PACK-LF DYNJ0545064AA CATH LAB ANGIO TRAY DYNJ83506A CATH LAB PACK DYNJ66366D DYNJ66366F DYNJT2202U CATH LAB PROCEDURE PK DYNJ57723C CATH LAB TRAY DYNJ37389P DYNJ37389Q CATH PACK DYNJ62595C DYNJ62595D DYNJ69997A HEART CATH PACK DYNJ85783 HEART CATH-SFMC DYNJ82434 INTERVENTIONAL PACK DYNJ56666D INTERVENTIONAL PACK-LF DYNJ37211J INTERVENTIONAL RADIOLOGY PK-LF DYNJ0516014AI IR PACK DYNJ36752B JUDKINS PACK DYNJ51126C M&E ANGIOGRAPHY PK DYNJ83812 NEURO ANGIO PACK DYNJ51697C NEUROLOGICAL CATH PACK DYNJ63434D OR HYBRID-MRMC DYNJ907758C PTCA PACK DYNJ55359C DYNJ55359D RADIOLOGY ANGIO MAJOR PACK DYNJ62858C SURGERY ANGIO PACK-LF PHS677784013B ANGIO ARTERIOGRAM PACK-LF DYNJ0774026J ANGIO IR PACK DYNJ31196G ANGIO PACK DYNJ30565F, DYNJ69200 ANGIOGRAM PACK-LF DYNJ21574K, DYNJ21574L ANGIOGRAPHY PACK DYNJ26855G, DYNJ26855I BGMC CARDIAC CATH PACK-LF DYNJ0664960D CARDIAC CATH DYNJ59898B CARDIAC CATH PACK DYNJ68653A, DYNJ69150A CATH LAB ANGIO PACK-LF DYNJ0545064Y CATH LAB PACK DYNJ28428F, DYNJ80457 CATH LAB-LF DYNJ51423F CATH PACK DYNJ62595B, DYNJ62983A CATH PROCEDURAL TRAY DYNJ43580D GENERAL ANGIO PACK DYNJ57760C HEART CATH PACK DYNJ69318 HEART CATH TRAY DYNJ53251J, DYNJ81557 IR PACK DYNJ65312 MAIN OR CATH LAB DYNJ61373A M CARDIAC CATH DYNJ58339A N CATH PACK NG140A OR RADIOLOGY PACK DYNJ62747 RADIOLOGY PACK DYNJ42633C R ANGIO PACK DYNJ36338C SPECIAL TRAY DYNJ65756A TAVR PACK DYNJ69246

Unapproved design changes to the products outside of the 510(k) clearance.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98601
Lot/product code:
DYNJ0373221P UDI-DI 10195327506575 (EA) 40195327506576 (CS) LOTS 24ABR861 DYNJ0516014AI UDI-DI 10198459246234 (EA) 40198459246235 (CS) LOTS 25BME135 25EMI244 DYNJ0545064AA UDI-DI 10195327327385 (EA) 40195327327386 (CS) LOTS 23CMD735 24BMA467 24CME416 24DMG231 24EMI752 24FMD170 24HMD253 24JMC552 24LMA043 25AMJ675 25CMB252 25EMD050 25EMF726 DYNJ0854485X UDI-DI 10195327450366 (EA) 40195327450367 (CS) LOTS 23GMA609 23HMF271 23IMH767 23JMI189 23LMH350 24DMC322 24FMB078 24HMA888 24HMJ182 24LMB120 DYNJ17218R UDI-DI 10195327459642 (EA) 40195327459643 (CS) LOTS 23GDA609 23HDB136 23IDB699 23KDA473 DYNJ28082I UDI-DI 10195327429713 (EA) 40195327429714 (CS) LOTS 23HBC876 23KBE157 24BBC678 24DBN465 24FBQ528 24GBO066 24HBF409 24KBG843 DYNJ30565G UDI-DI 10195327140687 (EA) 40195327140688 (CS) LOTS 22DDB753 22FDB429 22HDB442 22KDA279 22LDB909 23BDB812 23EDA339 23GDA440 23IDA647 23IDB341 23KDB268 24BDA252 24CDB812 24EDC035 24HDC110 24IMA915 24JMI363 24KMG704 24LMF893 DYNJ36752B UDI-DI 10195327226022 (EA) 40195327226023 (CS) LOT 23IMD713 DYNJ37211J UDI-DI 10195327363673 (EA) 40195327363674 (CS) LOTS 24ABL975 24BBM554 24DBA215 24EBF356 24FBR841 24HBF463 24IBV426 24KBC581 24LBM346 DYNJ37389P UDI-DI 10195327201418 (EA) 40195327201419 (CS) LOTS 23DBO927 23FBC559 23GBF169 23GBJ160 23IBM982 DYNJ37389Q UDI-DI 10195327531270 (EA) 40195327531271 (CS) LOTS 23KBL184 23LMC983 23LMG114 24AME115 24BMJ169 24CMB351 24CMI800 24FMH298 24GMH700 24HMH956 24IMI993 24KMF785 24LMF430 DYNJ37485D UDI-DI 10195327397333 (EA) 40195327397334 (CS) LOTS 23DBP804 23FBH420 23GBF219 23HBJ487 23IBO358 23KBA337 23LBC194 24ABI270 24CMD265 24CMG190 24EMJ851 24GMK004 24HMF977 24JMC975 24KMH243 24LMG715 DYNJ37724K UDI-DI 10195327531256 (EA) 40195327531257 (CS) LOTS 23JBS842 23LMF451 24BMH462 24EMI397 24EMJ503 24GMK100 24HMH553 24JMA589 24KMJ234 DYNJ38395G UDI-DI 10195327286767 (EA) 40195327286768 (CS) LOTS 22LMF926 23BMA411 23DMD076 23DMG120 DYNJ44293F UDI-DI 10195327265182 (EA) 40195327265183 (CS) LOTS 23CBH106 DYNJ44293G UDI-DI 10195327427276 (EA) 40195327427277 (CS) LOTS 23HBI186 23HBX788 23IBP108 23JBQ388 23JBT471 23KBX452 23LBU382 24ABH531 24ABU590 24CBQ251 24FBS495 24HBB684 DYNJ44293J UDI-DI 10198459252471 (EA) 40198459252472 (CS) LOTS 25ABS436 25CBC411 25DBS739 25EBN111 25GBK945 DYNJ47665F UDI-DI 10195327355210 (EA) 40195327355211 (CS) LOTS 23GMI750 23IMG679 DYNJ47665G UDI-DI 10195327535810 (EA) 40195327535811 (CS) LOTS 23KMC220 23LMD957 24AMH318 24CMC513 24CMF048 24EMF765 24FMB398 24GMD088 24HMG619 24KMC285 DYNJ51126C UDI-DI 10195327299996 (EA) 40195327299997 (CS) LOTS 24EBL991 24GBL127 24HBB815 24IBI837 24KBT622 DYNJ51239C UDI-DI 10195327663728 (EA) 40195327663729 (CS) LOTS 24FBM878 DYNJ51697C UDI-DI 10195327517267 (EA) 40195327517268 (CS) LOTS 24HBJ453 24JBQ619 24KBL433 DYNJ55359C UDI-DI 10198459167447 (EA) 40198459167448 (CS) LOTS 24JBW626 24LBJ492 25ABM557 DYNJ55359D UDI-DI 10198459253584 (EA) 40198459253585 (CS) LOTS 25CBJ836 25EBB180 25FBC620 DYNJ56666D UDI-DI 10195327366780 (EA) 40195327366781 (CS) LOTS 23FMB079 23HMC084 23JMH176 DYNJ57723C UDI-DI 10195327533007 (EA) 40195327533008 (CS) LOT 24GMA688 DYNJ62595C UDI-DI 10195327386511 (EA) 40195327386512 (CS) LOTS 23FBD527 23FBK131 DYNJ62595D UDI-DI 10195327482626 (EA) 40195327482627 (CS) LOTS 23IBD384 23JBT585 23KBV027 23LBS746 24ABX161 24BBA663 24DBO214 24EBN761 24GBJ844 24IBT077 24JBX775 24KBR861 DYNJ62858C UDI-DI 10195327265212 (EA) 40195327265213 (CS) LOTS 23GMB070 24BMD149 24HMA369 24HMJ618 24JME908 DYNJ63434D UDI-DI 10195327611200 (EA) 40195327611201 (CS) LOTS 24BBU728 24CBK568 24FBE982 24GBP703 24HBS440 24JBD723 24JBN341 24LBQ810 DYNJ65162B UDI-DI 10195327443948 (EA) 40195327443949 (CS) LOTS 23KBA866 23LBL832 DYNJ66366D UDI-DI 10195327493387 (EA) 40195327493388 (CS) LOTS 23LMC414 24BMD428 24EMG916 24EMJ523 24GMC227 24GMG298 24GMI398 DYNJ66366F UDI-DI 10198459033117 (EA) 40198459033118 (CS) LOTS 24HMI310 24IMB847 24IMD381 DYNJ66631A UDI-DI 10195327225193 (EA) 40195327225194 (CS) LOTS 23ABB849 23ABP692 23BBP518 23HBN017 23IBO135 24BBU796 24EBA783 24GBD375 24HBG027 24IBG782 24JBU401 24KBH848 24LBE218 DYNJ68653B UDI-DI 10195327475970 (EA) 40195327475971 (CS) LOTS 23IBO333 23JBE362 23KBS420 DYNJ68653C UDI-DI 10195327626570 (EA) 40195327626571 (CS) LOTS 24BBU897 24EBB962 24EBJ449 … (truncated, 15819 characters total — see the official FDA record for the full value)
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2026

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ANGIO KIT PACK DYNJ50783B ANGIO PHC DYNJ37485C C.I.C.N. ANGIO PACK DYNJ53064B FHT P NEURO PACK DYNJ39931D NEURO ARTERIOGRAM PACK-LF DYNJ0948060F NEURO KIT NAM0003 NEURO PACK DYNJ61542D NEURO RADIOLOGY PACK DYNJ59903B NEURO TRAY DYNJ84872A PK, CATH LAB-ANGIO DYNJ44027F QVH IR NEURO PACK DYNJ62176

Unapproved design changes to the products outside of the 510(k) clearance.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98601
Lot/product code:
DYNJ50783B UDI-DI 10193489227376 (EA) 40193489227377 (CS) LOT 23FBF183 DYNJ37485C UDI-DI 10193489760002 (EA) 40193489760003 (CS) LOTS 20BBX692 20DBC089 20EBG816 20FBR153 20HBN288 20IBK578 20KBW291 21BBB266 21CBW198 21FBH674 21GBS840 21GBS842 21JBU703 21LBX721 22BBV337 22EBN708 22IBJ467 22JBH996 22KBU901 22OBJ150 23ABG615 23BBF603 23CBC306 DYNJ53064B UDI-DI 10193489789164 (EA) 40193489789165 (CS) LOT 23HMI416 DYNJ39931D UDI-DI 10193489459364 (EA) 40193489459365 (CS) LOTS 23BBB182 23DBK363 24HBJ427 24JBI915 24JBV985 24KBH817 25GBI670 25IBS445 DYNJ0948060F UDI-DI 10889942825103 (EA) 40889942825104 (CS) LOTS 23FMA240 24EBR693 24GLB224 24HLA705 24JLA904 NAM0003 UDI-DI 10193489222555 (EA) 40193489222556 (CS) LOTS 20DBO375 20GBC317 20GBJ719 20HBC159 20HBD815 20HBF519 20IBA514 23CMC981 23DMC490 23DMF161 23GMA353 23HME057 23HMG264 23IMF173 23JMF878 23JMH829 23KME885 23LMA780 23LMD088 23LMG059 24AMF167 24AMH128 24EMG747 24HMJ041 24JMC680 DYNJ61542D UDI-DI 10195327507923 (EA) 40195327507924 (CS) LOT 24FMC929 DYNJ59903B UDI-DI 10195327131203 (EA) 40195327131204 (CS) LOTS 23EBQ216 23HBC089 23IBE176 23KBL439 23LBO494 24ABL938 24CBQ708 24EBB108 24FBA584 24FBN897 24JBC983 24JBO349 24KBB061 24KBT242 24LBP491 DYNJ84872A UDI-DI 10195327481506 (EA) 40195327481507 (CS) LOTS 23LBN462 24ABC179 DYNJ44027F UDI-DI 10193489783490 (EA) 40193489783491 (CS) LOTS 21FLA184 21FLA910 21ILA783 21JLA542 21LLA177 22ALA731 22BLA802 22DLA497 22ELA818 22FLA432 22GLB161 22HLB062 22JBC795 22JBM045 22KBO209 22KBO210 23DBR512 23FBQ563 23GBK955 23HBY707 23JBT738 23KBF311 23KBU563 24ABW467 24GBK560 24HBB843 24IBI798 24IBR643 24JBF292 DYNJ62176 UDI-DI 10193489631784 (EA) 40193489631785 (CS) LOTS 23ELA677 23GLA263 23KLB156 ***Updated 5/20/26 - The following lots were included in the customer letter but not the FDA submission.*** DYNJ0948060F lots 21AMA919 21AMB491 21BMC178 21HMF800 21JMG472 22AMB406 22CMI927 22EMC824 22GMF261 22IMA651 22JMG952 22KME549 22LMD531 23AMD745 23AMJ626 23CMB808 23DMC060 23EMB613 23EMG672 23GMG693 23GMI438 23IMG055 23KBR802 24ABP567 25ALA622 25ALA678 25CLA317 25DLA949 25ELA692; DYNJ39931D lots 21ABW861 21CBY118 21DBN140 21HBN105 21KBO171 21LBP808 21LBP811 22CBY154 22FBA263 22JBU799 23BBR777 23BBT177 23EBS918 23FBO983 23GBR315 23GBW410 23HBJ976 23IBJ863 23KBC962 23LBU944 24ABK323 24ABP442 24BBH773 24GBO821; DYNJ44027F lots 21BLA158 21CLA034 21DLA700 25EBE984 25EBU842; DYNJ50783B lots 21DBL972 21FBK452 21GBA227 21IBA354 21JBO239 21KBP327 21LBB845 21LBU425 22DBC322 22DBN517 22EBK090 22FBK172 22HBU114 22KBQ551 22KBQ552 23BBJ725 23CBO941 23EBC283; DYNJ59903B lots 22EBI499 22FBF028 22FBR425 22IBJ538 22LBQ311 23ABN466 23CBJ596 23CBP099 25DBF626; DYNJ62176 lots 21ALA437 21BLA178 21BLA238 21BLA352 21CLA516 21GLB100 22ALA163 22BLB207 22ELB041 22KLA092 22LLA728 23ALA743 23BLA184 23KLB124 24BLA180 24ELA039 24JLA075; DYNJ84872A lots 23IBS046; NAM0003 lots 21BBF218 21CBE230 21DBV018 21EBS508 21GBI653 21KBO486 21LBB470 22CME110 22EMH496 25AMG212 25BMA481 25BMF357 25BMH684 25DMH014 25DMH503 25EMD617 25EMI879
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2026

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ARTERIOGRAM TRAY 00-402001T, 00-402001U CATH LAB-VEIN PROCEDURES DYNJ60329A CENTRAL VENOUS ACCESS PACK-LF CVI5070 FISTULAGRAM PACK DYNJ66259 INVASIVE LINE INSERTION DYNJ44123C NON VASCULAR PACK DYNJ68037B, DYNJ68037C PICC ABSCESS PACK-LF DYNJ0774005G PICC LINEPACK (PCLUI)642-LF DYNJ47717B PICC PHC DYNJ37484C

Unapproved design changes to the products outside of the 510(k) clearance.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98601
Lot/product code:
00-402001T UDI-DI 10193489939682 (EA) 40193489939683 (CS) LOTS 23EBT729 23GBR995 23GBS336 00-402001U UDI-DI 10195327517380 (EA) 40195327517381 (CS) LOTS 23JBU819 23LBG449 24ABS585 24CBF190 24DBA960 24EBB048 24FBN231 24HBA892 24IBD316 24IBS824 DYNJ60329A UDI-DI 10193489972221 (EA) 40193489972222 (CS) LOT 24ABP714 CVI5070 UDI-DI 10195327526061 (EA) 40195327526062 (CS) LOT 24FBF359 DYNJ66259 UDI-DI 10193489325485 (EA) 40193489325486 (CS) LOT 22FMB867 DYNJ44123C UDI-DI 10195327599140 (EA) 40195327599141 (CS) LOTS 24ABQ097 24DMH637 24FMG692 24GMA523 24HME792 24JMA878 24JMI393 DYNJ68037B UDI-DI 10195327476458 (EA) 40195327476459 (CS) LOT 24HBK116 DYNJ68037C UDI-DI 10198459239328 (EA) 40198459239329 (CS) LOT 25BBO522 25DBR880 DYNJ0774005G UDI-DI 10193489271485 (EA) 40193489271486 (CS) LOTS 23DMC237 23EMC431 23FMG987 23HBL979 23JBG840 23KBJ401 23LBR858 24CBB784 24EBA777 DYNJ47717B UDI-DI 10195327355302 (EA) 40195327355303 (CS) LOTS 23GMB288 23HMA341 23HMH322 DYNJ37484C UDI-DI 10195327397340 (EA) 40195327397341 (CS) LOTS 24EDB695 24HDC050 24IMH716 24JMH721 24KMG262 ***Updated 5/20/26 - The following lots were included in the customer notification but not the FDA submission.*** 00-402001T Lots 21GBL509 21JBN647 21JBZ697 22BBX248 22DBL467 22DBS962 22GBC939 22HBO291 22HBO322 22IBN444 22IBO023 22KBT315 23BBA151 23CBI235 23DBM140; DYNJ0774005G Lots 21AMC932 21CMB295 21EMA842 21EMA842Z 21GME190 21IMF074 21JMA971 22AMB224 22CMF849 22CMG025 22DMF774 22HMD145 22HMH991 22JMF788 23AMH034 23CMA447; DYNJ37484C Lots 23EDA007 23GDA068 23HDC049 23JDA140 23LDA212 24BDA222 24DDA235 25AMA456 25AMH943; DYNJ44123C Lots 25BMC026; DYNJ47717B Lots 23DME176; DYNJ68037B Lots 23JBM013 23LBR847 24CBM608 24DBQ050 24HBT816 25ABA997
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2026

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ADD A ENDOVASCULAR PACK-LF DYNJ0429339L, DYNJ0429339M ANGIO ARTERIOGRAM PACK-LF DYNJ0774026K ANGIO KIT PACK DYNJ83746B ANGIO TRAY NO LIDO DYNJ85557A ANGIOGRAPHY PACK II DYNJ17218S, DYNJ17218T ARTERIOGRAM NEURO PACK-LF DYNJ0842499L ARTERIOGRAM PACK-LF DYNJ0842478M CARDIAC CATH II PK DYNJ21259O CARDIAC CATH PACK DYNJ68653D CATH LAB ANGIOGRAPHY PACK DYNJ50779G CATH LAB-LF DYNJ51423G CRANIOTOMY PACK-LF DYNJ0101292I DEEP BRAIN STIMULATION PACK DYNJ0842793I ENDO VASCULAR MINOR DYNJ87263 GENERAL ENDO PACK-LF DYNJ0842873L LEFT HEART DYNJ45984J LIPO PACK DYNJ87218 MAA Y90 TRAY DYNJ82191D MAIN OR CATH LAB DYNJ61373B MINIMALLY INVASIVE PACK-LF DYNJ0843063M NEURO CERVICAL PACK DYNJ0101287M NEURO RADIOLOGY RICHMOND DYNJ68365F NEURO VP SHUNT PACK-LF DYNJ0843121L NON-VASCULAR PACK DYNJ56386C, DYNJ56386D OR ANGIOGRAM PACK-LF DYNJ83656A, DYNJ83656B OR RADIOLOGY PACK DYNJ62747A PERCUTANEOUS ARTERIAL CATH PK DYNJ30551J PERIPHERAL ARTERIOGRAM RAD DYNJ61383C PICC ABSCESS PACK-LF DYNJ0774005I PICC TRAY DYNJ30554I PODIATRY PACK DYNJ46333G POSTERIOR SPINE PACK-LF DYNJ0843339P RRMC ANGIO PACK DYNJ36338D SPECIAL PROCEDURE PACK DYNJ88258 VASCULAR ACCESS PACK-LF DYNJ0101291G VASCULAR HYBRID DYNJ57543K VASCULAR PACK DYNJ82220D VISCERAL ANGIOGRAM PACK-LF DYNJ0429121M WPH EP PACK DYNJ62745A

Unapproved design changes to the products outside of the 510(k) clearance.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98601
Lot/product code:
DYNJ0429339L UDI-DI 10195327586508 (EA) 40195327586509 (CS) LOTS 24BMG223 24DMG627 DYNJ0429339M UDI-DI 10198459021541 (EA) 40198459021542 (CS) LOTS 24GMH043 24HMK218 DYNJ0774026K UDI-DI 10198459053115 (EA) 40198459053116 (CS) LOTS 24FBR752 24GBE275 24HBJ727 24IBD206 24KBB390 24KBT291 DYNJ83746B UDI-DI 10198459077760 (EA) 40198459077761 (CS) LOTS 24HBB576 24JBF419 24LBG659 DYNJ85557A UDI-DI 10195327657901 (EA) 40195327657902 (CS) LOT 24HBT042 DYNJ17218S UDI-DI 10195327617547 (EA) 40195327617548 (CS) LOTS 24ADC205 24DDA061 DYNJ17218T UDI-DI 10198459014956 (EA) 40198459014957 (CS) LOTS 24FDA217 24GDB466 24IDB458 DYNJ0842499L UDI-DI 10198459119248 (EA) 40198459119249 (CS) LOT 24LDB079 DYNJ0842478M UDI-DI 10198459119255 (EA) 40198459119256 (CS) LOT 24LDB078 DYNJ21259O UDI-DI 10195327666323 (EA) 40195327666324 (CS) LOTS 24EBQ265 24EBQ331 24KBG416 24LBP987 DYNJ68653D UDI-DI 10198459123122 (EA) 40198459123123 (CS) LOTS 24IBI799 24JBJ553 24KBT807 24LBQ652 DYNJ50779G UDI-DI 10195327686499 (EA) 40195327686490 (CS) LOTS 24GMA788 24HMA312 24IMI472 24KMC197 DYNJ51423G UDI-DI 10198459022395 (EA) 40198459022396 (CS) LOTS 24FLA167 24HLA548 24HLA720 24JLA538 DYNJ0101292I UDI-DI 10198459119064 (EA) 40198459119065 (CS) LOTS 24JDA749 24KDB872 24LDA883 DYNJ0842793I UDI-DI 10198459119095 (EA) 40198459119096 (CS) LOTS 24IDA565 24JDB658 DYNJ87263 UDI-DI 10198459026263 (EA) 40198459026264 (CS) LOTS 24GMF532 24KME090 DYNJ0842873L UDI-DI 10198459119163 (EA) 40198459119164 (CS) LOTS 24JDB216 24KMI624 DYNJ45984J UDI-DI 10198459072499 (EA) 40198459072490 (CS) LOTS 24HMD351 24IMJ054 DYNJ87218 UDI-DI 10198459018800 (EA) 40198459018801 (CS) LOTS 24GBA517 24IBO012 24LBT366 DYNJ82191D UDI-DI 10198459099755 (EA) 40198459099756 (CS) LOTS 24HMI555 24IMF587 24KMD232 DYNJ61373B UDI-DI 10195327591298 (EA) 40195327591299 (CS) LOTS 23LBS736 24ABA334 24KBF375 24LBM612 DYNJ0843063M UDI-DI 10198459119460 (EA) 40198459119461 (CS) LOTS 24LDB299 DYNJ0101287M UDI-DI 10198459119491 (EA) 40198459119492 (CS) LOTS 24JDA631 24KDB258 DYNJ68365F UDI-DI 10198459130038 (EA) 40198459130039 (CS) LOTS 24LBA409 24LBJ115 24LBJ634 DYNJ0843121L UDI-DI 10198459119507 (EA) 40198459119508 (CS) LOTS 24JMB397 24JMF145 DYNJ56386C UDI-DI 10195327571252 (EA) 40195327571253 (CS) LOTS 23LBI856 24CBJ902 24FBG624 24FBI743 24FBO911 24HBM314 DYNJ56386D UDI-DI 10198459123382 (EA) 40198459123383 (CS) LOTS 24JBX744 24KBH891 24LBS655 DYNJ83656A UDI-DI 10195327600006 (EA) 40195327600007 (CS) LOTS 24DMF381 24GMG344 DYNJ83656B UDI-DI 10198459119538 (EA) 40198459119539 (CS) LOT 24KMF093 DYNJ62747A UDI-DI 10195327576530 (EA) 40195327576531 (CS) LOTS 24EBI547 24FBR560 24IBG783 24LBK728 DYNJ30551J UDI-DI 10198459131004 (EA) 40198459131005 (CS) LOTS 24LLA323 25HLA222 DYNJ61383C UDI-DI 10195327593346 (EA) 40195327593347 (CS) LOTS 24CLA801 24DLA314 24ELA254 24FLA499 24GLA460 24HLA582 24HLB160 24JLB130 24KLB068 24LLA374 25ALA225 25ALB027 25CLA749 25DLA276 25GLA032 25ILA468 25JLA750 DYNJ0774005I UDI-DI 10198459053184 (EA) 40198459053185 (CS) LOTS 24GBE276 24HBS310 DYNJ30554I UDI-DI 10198459131011 (EA) 40198459131012 (CS) LOTS 24LLB049 25HLA223 25HLA971 DYNJ46333G UDI-DI 10195327542320 (EA) 40195327542321 (CS) LOT 24ABS351 DYNJ0843339P UDI-DI 10198459119330 (EA) 40198459119331 (CS) LOTS 24JDC273 24LDA042 DYNJ36338D UDI-DI 10195327624002 (EA) 40195327624003 (CS) LOTS 24BMJ645 24CMG670 24DMC608 24EMH999 24FME392 24JMD753 24JMI596 24KME048 24LMA450 DYNJ88258 UDI-DI 10198459133114 (EA) 40198459133115 (CS) LOT 24JBB074 DYNJ0101291G UDI-DI 10198459119439 (EA) 40198459119430 (CS) LOTS 24IDB422 24KDB372 DYNJ57543K UDI-DI 10198459004124 (EA) 40198459004125 (CS) LOTS 24FMI037 24GMF547 24IMA891 24JME621 DYNJ82220D UDI-DI 10198459103377 (EA) 40198459103378 (CS) LOT 24LMC859 DYNJ0429121M UDI-DI 10195327675813 (EA) 40195327675814 (CS) LOTS 24DMA039 24DMG180 24EMH743 24IMF503 DYNJ62745A UDI-DI 10195327686222 (EA) 40195327686223 (CS) LOTS 24KBR735 24LBK675 ***Updated 5/20/26 - The following lots were included in the customer letter but not the FDA submission.*** DYNJ0101287M lots 25BMC014; DYNJ0429121M lots 24GME309 25AMA768 25AMI616 25CMC127 25DME972 25EMH823; DYNJ0429339M lots 25AMI338 25BMI962 25DMG132; DYNJ0774005I lots 25ABU445 25EBJ726; DYNJ0774026K lots 25ABL910 25CBC859; DYNJ0842478M lots 25BMD033; DYNJ0842499L lots 25ADA394 25ADB067 25BDB213; DYNJ0842873L lots 25AMF044 25BMI157 25CMJ723; DYNJ0843063M lots 24KDA944 25BMC710 25CMB746; DYNJ0843121L lots 25BMA139 25BMG893; DYNJ0843339P lots 25AMC… (truncated, 5722 characters total — see the official FDA record for the full value)
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2026

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. PICC LINEPACK (PCLUI)642-LF DYNJ47717A

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
99062
Lot/product code:
DYNJ47717A UDI-DI 10193489454529 Lots 21CMD153 21EMC033 21HMB521 21HMF278 21IME100 21IMG896 21JMG286 22AME235 22BMH056 22EMF125 22GMI215 22JME782 22LMC139 22LMC336
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2026

Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. MTS RH LFT HRT KIT, Medline SKU # 60010508; 2. MTS 3V W/GUIDE, Medline SKU # 60100701; 3. ANGIOGRAPHY KIT, Medline SKU # 60131209; 4. MTS LHK, Medline SKU # 60160075; 5. MTS LHK, Medline SKU # 60161954; 6. MTO LHK, Medline SKU # 60230148; 7. GENERAL SURGERY TRAY, Medline SKU # 00-500510I; 8. BIOBURDEN TEST KIT - 686, Medline SKU # BIOB686; 9. RADIO ANGIO UNIV HOSP PACK-LF, Medline SKU # DYNJ0376145M; 10. SPECIALS PACK-LF, Medline SKU # DYNJ0392706K; 11. CARDIAC CATH PACK-LF, Medline SKU # DYNJ0451426O; 12. CARDIAC CATH PACK-LF, Medline SKU # DYNJ0451426P; 13. CARDIAC CATH PACK, Medline SKU # DYNJ07953N; 14. CATH PACK-LF, Medline SKU # DYNJ0803367J; 15. E.P. TRAY, Medline SKU # DYNJ19343J; 16. CARDIAC CATH PACK, Medline SKU # DYNJ20898T; 17. CATH LAB TRAY, Medline SKU # DYNJ24250G; 18. CATH LAB PACK-LF, Medline SKU # DYNJ38333D; 19. CATH LAB PACK-LF, Medline SKU # DYNJ38333F; 20. EP IMPLANT PACK-LF, Medline SKU # DYNJ38910D; 21. ADULT CATH LAB PACK, Medline SKU # DYNJ40380J; 22. CRANIOTOMY PACK-LF, Medline SKU # DYNJ43403D; 23. LAP CHOLE PACK, Medline SKU # DYNJ48487F; 24. CATH LAB ANGIOGRAPHY PACK, Medline SKU # DYNJ50779G; 25. CATH LAB ANGIOGRAPHY PACK, Medline SKU # DYNJ50779I; 26. HYBRID, Medline SKU # DYNJ57049N; 27. SPECIALS PK, Medline SKU # DYNJ57713C; 28. SPECIALS PK, Medline SKU # DYNJ57713D; 29. SPECIALS PK, Medline SKU # DYNJ57713F; 30. CARDIAC CATH LAB, Medline SKU # DYNJ57748A; 31. TAVR PACK, Medline SKU # DYNJ58771G; 32. CATH PACK GWV, Medline SKU # DYNJ59229F; 33. HEART CATH PACK, Medline SKU # DYNJ61294F; 34. CATH LAB PACK, Medline SKU # DYNJ61353C; 35. DEVICE IMPLANT PACK, Medline SKU # DYNJ64636A; 36. CUSTOM PROCEDURE KIT, Medline SKU # DYNJ65277A; 37. GENERAL VASCULAR PACK RFID-V2, Medline SKU # DYNJ66442F; 38. CARDIAC CATH PACK, Medline SKU # DYNJ69845C; 39. OMF MINOR PACK, Medline SKU # DYNJ83991C; 40. HEART CATH PACK, Medline SKU # DYNJ84133B; 41. SPECIAL PROCEDURES, Medline SKU # DYNJ85425B; 42. PRIMARY PACK, Medline SKU # DYNJT3093; 43. CARDIAC CATH PACK, Medline SKU # DYNJT3522A; 44. CARDIAC CATH PACK, Medline SKU # DYNJT3522B; 45. TOTAL KNEE PACK, Medline SKU # DYNJT4069; 46. CARDIAC CATH PACK, Medline SKU # DYNJT5685; 47. CATH PACK, Medline SKU # DYNJT6544; 48. PACK CARDIAC CATH, Medline SKU # DYNJT7591; 49. OBL CATH VEIN PACK, Medline SKU # DYNJT7863; 50. TUMESCENT SYRINGE KIT, Medline SKU # DYNJTUMSYR; 51. CSTM LH KIT, Medline SKU # VASC1054; 52. LHK, Medline SKU # VASC1130A; 53. MANIFOLD KIT, Medline SKU # VASC1137A; 54. LHK, Medline SKU # VASC1299A; 55. LHK, Medline SKU # VASC1399B; 56. LHK, Medline SKU # VASC1403; 57. IR 2 PORT, Medline SKU # VASC1404; 58. LHK, Medline SKU # VASC1405; 59. LHK, Medline SKU # VASC1455A; 60. TWO PORT MANIFOLD KIT, Medline SKU # VASC1496; 61. RHK, US, NAMIC MANIFOLD, Medline SKU # VASC1502; 62. LHK, Medline SKU # VASC1555; 63. 4 VALVE,PERC,MANIFOLD,KIT, Medline SKU # VASC1609; 64. LHK, Medline SKU # VASC1668; 65. LHK, Medline SKU # VASC1694; 66. LHK, Medline SKU # VASC1805; 67. TVR, Medline SKU # VASC1816.

Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98598
Lot/product code:
Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 26BBI625; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 26ABB718; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25JBJ140; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25HBF702; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25GBC747; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25DBR341; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25CBK686; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25ABR102; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 24IBK765; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 24GBS605; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 24EBO156; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 24BBG055; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 24ABH036; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 23LBI829; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 23KBN009; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 23FBO996; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 23FBA259; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 23EBD151; Medline SKU # 60100701, UDI/DI each 10193489045246, UDI/DI case 40193489045247, Lot Number: 24IBE239; Medline SKU # 60100701, UDI/DI each 10193489045246, UDI/DI case 40193489045247, Lot Number: 24HBR112; Medline SKU # 60100701, UDI/DI each 10193489045246, UDI/DI case 40193489045247, Lot Number: 24GBY032; Medline SKU # 60100701, UDI/DI each 10193489045246, UDI/DI case 40193489045247, Lot Number: 24BBO470; Medline SKU # 60100701, UDI/DI each 10193489045246, UDI/DI case 40193489045247, Lot Number: 24ABB436; Medline SKU # 60100701, UDI/DI each 10193489045246, UDI/DI case 40193489045247, Lot Number: 23LBA225; Medline SKU # 60100701, UDI/DI each 10193489045246, UDI/DI case 40193489045247, Lot Number: 23GBK257; Medline SKU # 60100701, UDI/DI each 10193489045246, UDI/DI case 40193489045247, Lot Number: 23FBG433; Medline SKU # 60100701, UDI/DI each 10193489045246, UDI/DI case 40193489045247, Lot Number: 23FBC618; Medline SKU # 60100701, UDI/DI each 10193489045246, UDI/DI case 40193489045247, Lot Number: 23EBX036; Medline SKU # 60100701, UDI/DI each 10193489045246, UDI/DI case 40193489045247, Lot Number: 23DBD220; Medline SKU # 60131209, UDI/DI each 10193489046779, UDI/DI case 40193489046770, Lot Number: 24HBJ211; Medline SKU # 60160075, UDI/DI each 10193489048872, UDI/DI case 40193489048873, Lot Number: 24EBQ349; Medline SKU # 60160075, UDI/DI each 10193489048872, UDI/DI case 40193489048873, Lot Number: 24CBD613; Medline SKU # 60160075, UDI/DI each 10193489048872, UDI/DI case 40193489048873, Lot Number: 24ABL640; Medline SKU # 60160075, UDI/DI each 10193489048872, UDI/DI case 40193489048873, Lot Number: 23KBB857; Medline SKU # 60160075, UDI/DI each 10193489048872, UDI/DI case 40193489048873, Lot Number: 23IBC156; Medline SKU # 60160075, UDI/DI each 10193489048872, UDI/DI case 40193489048873, Lot Number: 23FBJ161; Medline SKU # 60160075, UDI/DI each 10193489048872, UDI/DI case 40193489048873, Lot Number: 23FBC907; Medline SKU # 60161954, UDI/DI each 10193489049091, UDI/DI case 40193489049092, Lot Number: 26ABD974; Medline SKU # 60161954, UDI/DI each 10193489049091, UDI/DI case 40193489049092, Lot Number: 25JBM213; Medline SKU # 60161954, UDI/DI each 10193489049091, UDI/DI case 40193489049092, Lot Number: 25FBK284; Medline SKU # 60161954, UDI/DI each 10193489049091, UDI/DI case 40193489049092, Lot Number: 25FBK967; Medline SKU # 60161954, UDI/DI each 10193489049091, UDI/DI case 40193489049092, Lot Number: 24KBN942; Medline SKU # 60161954, UDI/DI each 10193489049091, UDI/DI case 40193489049092, Lot Number: 24JBC074; Medline SKU # 60161954, UDI/DI each 10193489049091, UDI/DI case 40193489049092, Lot Number: 24HBQ995; Medline SKU # 60161954, UDI/DI each 10193489049091, UDI/DI case 40193489049092, Lot Number: 24GBP001; Medline SKU # 60161954, UDI/DI each 10193489049091, UDI/DI case 40193489049092, Lot Number: 24CBF239; Medline SKU # 60161954, UDI/DI each 10193489049091, UDI/DI case 40193489049092, Lot Number: 24ABJ769; Medline SKU # 60161954, UDI/DI each 10193489049091, UDI/DI case 40193489049092, Lot Number: 23LBP098; Medline SKU # 60161954, UDI/DI each 10193489049091, UDI/… (truncated, 34496 characters total — see the official FDA record for the full value)
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2026

SIGNA Premier systems

Whole-Body MR scanners used to produce images of the inside of the human body to aid diagnosis of disease may have been manufactured/serviced with ferrous (steel) fittings instead of non-ferrous (brass) fittings on the magnet rear and if system is accessed to perform service while the magnet is ramped, the magnetic field could attract the ferrous fittings potentially resulting in personnel injury.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98579
Lot/product code:
UDI-DI/GTIN: 00840682135269, 00195278010797. System ID: 415353UMR2, 415723SHMR19, 413253MR3T, 908725MR, 609652MR3T, M48823, 7168453T, 513584MR5, 513636EASTMR, 513636T1MR, 605333MRPRM, 832522CRMR1, 703858PRE2, 804675VA3T, 082427110162, 082427220143, 082427020147, 082427200242, 082427160461, 082427250139, 082427140382, M4216469, 353745MR01, GON5655515, KRMR56474971, KRMR56203791, KRMR55433661, KRMR56344161, KRMR55774051, KRMR55914661, NOMRI26833321, 15974045, GON1882380, ESMRI27056983, ESMRI26960129, A203MR06, 690120MR01, 11524261, VNMRI26792525, VNMRI26592248, VNMRI26809677
Recalling firm:
GE Healthcare LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2026

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CRANIOTOMY PACK-LF DYNJ0101292F DYNJ0101292G HYBRID PACK DYNJ65925A LAMINECTOMY DYNJ905156L DYNJ905156M DYNJ905156N DYNJ905156O DYNJ905156P MAJOR EXTREMITY DYNJ905159F DYNJ905159I DYNJ905159J DYNJ905159K NEURO CERVICAL PACK DYNJ0101287J DYNJ0101287K NEURO SPINE PACK DYNJ81612C POSTERIOR SPINE PACK-LF DYNJ0843339L DYNJ0843339M DYNJ0843339N SPINE PACK DYNJ30150F

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
99062
Lot/product code:
DYNJ0101292F UDI-DI 10193489434040 Lots 21CDC411 21EDA768 21EDC107 21HDA937 21HDC815 21IDC204 21KDA780 22ADA317 22ADC159 22BDA066 22CDA470 22EDB043 22EDB214 22IDA695 DYNJ0101292G UDI-DI 10195327286255 Lots 22KDB031 23BDA768 23DDA637 23EDA187 23HDB829 23JDA057 23LDA727 24ADA469 24ADC048 24HDA453 DYNJ65925A UDI-DI 10193489427264 Lots 21BLA577 21DLA194 21DLA397 DYNJ905156L UDI-DI 10193489397369 Lots 21EBI411 DYNJ905156M UDI-DI 10193489908961 Lots 21HBC497 21HBT672 DYNJ905156N UDI-DI 10193489996371 Lots 21LBQ932 22BBB708 22DBP992 22DBQ776 22FBQ287 DYNJ905156O UDI-DI 10195327219949 Lots 22HBR341 22HBW892 22KBC930 22KBC932 22KBK539 23DBD118 23DBD666 23EBC709 DYNJ905156P UDI-DI 10195327405847 Lots 23GBH099 23GBH829 23GBH830 23HBK732 23JBS610 23JBS704 23LBD615 23LBO186 24ABQ915 24CBD453 DYNJ905159F UDI-DI 10193489397475 Lots 21CBF265 21FBF870 21HBK984 21HBO573 21JBD205 21LBC602 22BBQ673 22CMH568 22EMD159 22GMG564 DYNJ905159I UDI-DI 10195327219987 Lots 22JMF458 22LMH325 23DMI033 23EMF058 DYNJ905159J UDI-DI 10195327406028 Lots 23FMC192 23FMG785 23GMI481 23HMF747 23IMG923 23IMI383 23JMA274 DYNJ905159K UDI-DI 10195327556884 Lots 23LMF481 24BMA401 24CMJ402 DYNJ0101287J UDI-DI 10195327286484 Lots 23ADA628 23EDA927 23GDA587 23HDC199 DYNJ0101287K UDI-DI 10195327500177 Lot 23JDC525 DYNJ81612C UDI-DI 10195327536145 Lot 24BBB406 DYNJ0843339L UDI-DI 10193489345544 Lots 21EDC223 21FDB611 DYNJ0843339M UDI-DI 10193489964615 Lots 21HDB435 21IDB916 21KDC093 22BDA178 22DDA738 22EDA069 22EDB876 22HDC322 22JDA142 22KDB701 DYNJ0843339N UDI-DI 10195327286552 Lots 23ADA251 23BDB752 23DDB611 23FDA191 23HDB830 23IDB329 23JDA990 23LDA449 DYNJ30150F UDI-DI 10889942186679 Lot 24BBE416
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2026

Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. ROBOTIC PACK, Medline SKU # DYNJ58475F; 2. URO/GEN ROBOTIC PACK, Medline SKU # DYNJ60803J.

Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98598
Lot/product code:
Medline SKU # DYNJ58475F, UDI/DI each 10198459572388, UDI/DI case 40198459572389, Lot Number: 25LMK173; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 26BMA268; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 26AMH928; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 25EMD876; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 25EMA519; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 25DMA846; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 25BMH004; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 25BMA218; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 24KMI208; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 24KMC007; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 24JMD850; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 24IMI939; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 24EDB694; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 24DDB793; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 24CDB207; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 24BDB439; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 23GDB756; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 23GDA532.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2026

Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: GLOVE PACK 7.0 (15PK), Medline SKU # DYNJ63673D

Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98598
Lot/product code:
Medline SKU # DYNJ63673D, UDI/DI each 10195327304843, UDI/DI case 40195327304844 , Lot Number: 25GLA141
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2026

NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027; 2. SYRINGE,10ML,TR/FR,RA,W/RES, Medline SKU 70085007; 3. MTO,SYRINGE,10ML,TR/FG,RA,-,PKG, Medline SKU 70085107; 4. SYRINGE,12ML,TR/FR,RA,W/RES, Medline SKU 70087007; 5. MTO,SYRINGE,12ML,TR/FG,RA,W/RES, Medline SKU 70087107; 6. SYRINGE,12ML,TR/FR,RA,W/O,RES,-,PKG, Medline SKU 70088007; 7. SYRINGE,10ML,PP/FR,RA,-,PKG, Medline SKU 70095007; 8. SYRINGE,10ML,PP/FG,RA,-,PKG, Medline SKU 70095107; 9. SYRINGE,12ML,W/RES,PP/FR,RA,PG, Medline SKU 70097007; 10. SYRINGE,12ML,PP/FG,RA,W/RES,-,PKG, Medline SKU 70097107; 11. SYRINGE,12ML,PP/FG,RA,W/O,RES, Medline SKU 70098107; 12. SYRINGE,20ML,TR/FR,RA,OEM,PG, Medline SKU 80075027; 13. SYRINGE,10ML,ANGIO,W/RA,-,OEM, Medline SKU 80085007; 14. SYRINGE,12ML,TR/FR,RA,OEM, Medline SKU 80087007; 15. SYRINGE,10ML,PP/FR,RA,-,OEM,-,PG, Medline SKU 80095007; 16. SYRINGE,10ML,PP/FG,RA,OEM,PG, Medline SKU 80095107; 17. SYRINGE,12ML,PP/FG,RA,-,OEM,-,PG, Medline SKU 80097107; 18. CATH SET UP PACK, Medline SKU DYNJ46711O

Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98598
Lot/product code:
Medline SKU 60010027, Lot Number 25EBF689; Medline SKU 60010027, Lot Number 25CBL960; Medline SKU 60010027, Lot Number 24LBO743; Medline SKU 60010195, Lot Number 25ABI082; Medline SKU 60010195, Lot Number 24IBJ827; Medline SKU 60010195, Lot Number 24HBO437; Medline SKU 60010195, Lot Number 24DBR149; Medline SKU 60010195, Lot Number 24CBF820; Medline SKU 60011433, Lot Number 26BBJ156; Medline SKU 60011433, Lot Number 26ABH642; Medline SKU 60011433, Lot Number 25KBJ356; Medline SKU 60011433, Lot Number 25HBQ865; Medline SKU 60011433, Lot Number 25FBS131; Medline SKU 60011433, Lot Number 25DBR246; Medline SKU 60011433, Lot Number 25CBS392; Medline SKU 60011433, Lot Number 25CBB739; Medline SKU 60011433, Lot Number 24JBR628; Medline SKU 60011433, Lot Number 24EBL302; Medline SKU 60011433, Lot Number 24BBS083; Medline SKU 60011433, Lot Number 23LBH316; Medline SKU 60011433, Lot Number 23JBP386; Medline SKU 60011433, Lot Number 23HBB765; Medline SKU 60011433, Lot Number 23FBC617; Medline SKU 60011433, Lot Number 23EBD152; Medline SKU 60011433, Lot Number 23DBR429; Medline SKU 60020323, Lot Number 25LBK008; Medline SKU 60020323, Lot Number 25JBJ120; Medline SKU 60020323, Lot Number 25HBQ807; Medline SKU 60020323, Lot Number 25GBA069; Medline SKU 60020323, Lot Number 25EBC643; Medline SKU 60020323, Lot Number 25CBE212; Medline SKU 60023904, Lot Number 26BBB137; Medline SKU 60023904, Lot Number 26ABL323; Medline SKU 60023904, Lot Number 25JBM214; Medline SKU 60023904, Lot Number 25EBM357; Medline SKU 60023904, Lot Number 25DBC905; Medline SKU 60023904, Lot Number 25CBU751; Medline SKU 60023904, Lot Number 25BBL199; Medline SKU 60023904, Lot Number 25ABP367; Medline SKU 60033123, Lot Number 25LBD357; Medline SKU 60033123, Lot Number 25JBS750; Medline SKU 60033123, Lot Number 25IBF219; Medline SKU 60033123, Lot Number 25HBQ032; Medline SKU 60033123, Lot Number 25GBJ123; Medline SKU 60033123, Lot Number 25FBF145; Medline SKU 60033123, Lot Number 25BBR862; Medline SKU 60033123, Lot Number 25BBI613; Medline SKU 60035431, Lot Number 25FBJ204; Medline SKU 60035431, Lot Number 25FBJ126; Medline SKU 60035431, Lot Number 25DBR499; Medline SKU 60035431, Lot Number 25CBG499; Medline SKU 60035431, Lot Number 25BBL338; Medline SKU 60035431, Lot Number 25ABS403; Medline SKU 60035431, Lot Number 25ABJ801; Medline SKU 60040706, Lot Number 25ABR093; Medline SKU 60061801, Lot Number 26ABB719; Medline SKU 60061801, Lot Number 25LBD922; Medline SKU 60061801, Lot Number 25KBB972; Medline SKU 60061801, Lot Number 25IBQ948; Medline SKU 60061801, Lot Number 25IBG717; Medline SKU 60061801, Lot Number 25ABF762; Medline SKU 60080349, Lot Number 26ABT007; Medline SKU 60080349, Lot Number 25KBA752; Medline SKU 60080349, Lot Number 25IBF307; Medline SKU 60080349, Lot Number 25EBF843; Medline SKU 60080349, Lot Number 25CBK717; Medline SKU 60080349, Lot Number 25CBA408; Medline SKU 60080349, Lot Number 24LBN469; Medline SKU 60100029, Lot Number 26BBH341; Medline SKU 60100029, Lot Number 26ABL391; Medline SKU 60100029, Lot Number 25LBS254; Medline SKU 60100029, Lot Number 25KBG811; Medline SKU 60100029, Lot Number 25JBB101; Medline SKU 60100029, Lot Number 25HBG368; Medline SKU 60100029, Lot Number 25EBR355; Medline SKU 60100029, Lot Number 24LBO386; Medline SKU 60100029, Lot Number 24LBN875; Medline SKU 60100599, Lot Number 25DBV070; Medline SKU 60100599, Lot Number 25DBR988; Medline SKU 60100599, Lot Number 25DBC935; Medline SKU 60100599, Lot Number 25CBR993; Medline SKU 60100599, Lot Number 25BBK878; Medline SKU 60100599, Lot Number 25ABL231; Medline SKU 60100599, Lot Number 24JBK614; Medline SKU 60100599, Lot Number 24FBT353; Medline SKU 60100599, Lot Number 24CBJ893; Medline SKU 60100718, Lot Number 26ABV508; Medline SKU 60100718, Lot Number 25LBN909; Medline SKU 60100718, Lot Number 25JBY063; Medline SKU 60100718, Lot Number 25FBU152; Medline SKU 60100718, Lot Number 25FBH866; Medline SKU 60100718, Lot Number 25DBQ311; Medline SKU 60100718, Lot Number 25CBB740; Medline SKU 60100718, Lot Number 25BBL043; Medline SKU 60100718, Lot Number 24KBR054; Medline SKU 60100718, Lot Number 24IBQ373; Medline SKU 60100718, Lot Number 24EBV454; Medline SKU 60100718, Lot Number 24EBE042; Medline SKU 60100718, Lot Number 24ABI380; Medline SKU 60100718, Lot Number 23IBO420; Medline SKU 60100718, Lot Number 23HBB880; Medline SKU 60100718, Lot Number 23FBA834; Medline SKU 60100718, Lot Number 23CBC354; Medline SKU 60101591, Lot Number 25DBB111; Medline SKU 60101591, Lot Number 25CBN928; Medline SKU 60101591, Lot Number 25ABK745; Medline SKU 60122271, Lot Number 25HBL102; Medline SKU 60122271, Lot Number 25EBQ169; Medline SKU 60122271, Lot Number 25EBC251; Medline SKU 60122271, Lot Number 25CBL109; Medline SKU 60122271, Lot Number 25BBE731; Medline SKU 60122271, Lot Number 25ABV175; Medline SKU 60130506, Lot Number 25FBK959; Medline SKU 60130506, Lot Nu… (truncated, 171938 characters total — see the official FDA record for the full value)
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2026

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CATARACT FULL BODY DYNJ85743 MAJOR VASCULAR PACK DYNJ81610C MINIMALLY INVASIVE PACK-LF DYNJ0843063L PEDIATRIC CATH ANGIO PACK DYNJ54755J PERIPHERAL ARTERIOGRAM RAD DYNJ61383C POSTERIOR SPINE PACK-LF DYNJ0843339O UPPER EXTREMITY DYNJ61907A VISCERAL ANGIOGRAM PACK-LF DYNJ0429121L

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
99062
Lot/product code:
DYNJ85743 UDI-DI 10195327542337 Lots 24ABP082 24BBA479 DYNJ81610C UDI-DI 10195327556938 Lot 24BBB405 DYNJ0843063L UDI-DI 10195327567071 Lots 23LDB992 24BDA641 24BDA782 24FDA795 24GDB014 24HDB074 DYNJ54755J UDI-DI 10195327549909 Lots 24ABJ741 24CBI600 24EBA488 24FBM084 24GBN355 24HBH571 DYNJ61383C UDI-DI 10195327593346 Lot 24CLA801 DYNJ0843339O UDI-DI 10195327567057 Lots 24CDB480 24DDA248 24GDB068 DYNJ61907A UDI-DI 10195327542450 Lot 24ABP069 DYNJ0429121L UDI-DI 10195327587697 Lot 24BMH315
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled February 26, 2026

Levothyroxine Sodium Tablets USP 150 mcg, 1000 Tablets bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Princeton, NJ, Manufactured by: Macleods Pharmaceuticals Ltd., Sarigam, Valsad, Guajarat, INDIA NDC 33342-401-44

Weaker than it should be Drug

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0403-2026
Lot/product code:
Lot 16240062A, exp date 3/2026
Recalling firm:
MACLEODS PHARMA USA, INC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 25, 2026

Medline Kits: 1) MTS LEFT HEART KIT-CAROLINAS HOS, Model Number: 60021775; 2) DBD-MTS LHK BHS BAPTIST. LOUISVI, Model Number: 60022026; 3) MTO LEFT HEART KIT SUMMA BARBERT, Model Number: 60022673; 4) MTS LH KIT-UNIV OF MIAMI PG, Model Number: 60030817; 5) MTS LEFT HEART KIT SPRINGFIELD R, Model Number: 60031245; 6) MTS PERIPHERAL KIT SPRINGFIELD R, Model Number: 60031247; 7) MTS LEFT HEART KIT-COLISEUM MED, Model Number: 60031928; 8) MTS LEFT HEART KIT -2-CALIFORNIA, Model Number: 60033011; 9) MTS LEFT HEART KIT JOHN MUIR CON, Model Number: 60040273; 10) MTS EP MANIFOLD KIT TEXAS HLTH P, Model Number: 60041268; 11) MTS 3V MANIFOLD KIT-SPARROW HOSP, Model Number: 60050097; 12) MTS LEFT HEART KIT FORT SANDERS, Model Number: 60060387; 13) MTS LEFT HEART KIT-GOOD SAMARITA, Model Number: 60070435; 14) DBD-MTS ANGIO KIT-MOUNT HOOD MED, Model Number: 60070521; 15) MTS LFT HRT KIT-GRAND VIEW PG, Model Number: 60071743; 16) MTS CUSTOM MANIFOLD KIT-INGALLS, Model Number: 60090078; 17) MTS CATH LAB KIT - HEARTLAND PG, Model Number: 60090542; 18) MTS LEFT HEART KIT-W.C.A PG, Model Number: 60100071; 19) MTS MANIFOLD KIT-GENESYS REG MED, Model Number: 60100254; 20) MTS 4V W/PRO STA-ST.JOHNS REG ME, Model Number: 60100439; 21) MTS LEFT HEART KIT JEANES HOSPIT, Model Number: 60101773; 22) MTS LEFT HEART KIT-ST. MARYS OF, Model Number: 60131099; 23) DBD-MTS LEFT HEART KIT-LEHIGH VA, Model Number: 60132653; 24) MTS LEFT HEART KIT (3V DT WASTE), Model Number: 60138326; 25) MTS LF HRT KIT-PRESBYTERIAN UNIV, Model Number: 60160148; 26) MTS LEFT HEART KIT-PENINSULA REG, Model Number: 60160428; 27) MTS LEFT HEART KIT BARNES ST.PET, Model Number: 60161135; 28) MTO OR ENDO KIT - PARK RIDGE HOS, Model Number: 60163618; 29) MTS 3V W/DT-CORPUS CHRISTI M.C., Model Number: 60181531; 30) MTS 3V PERC MANIFOLD KIT WEST. A, Model Number: 60182137; 31) MTO CATH KIT PAMPA REGIONAL MED, Model Number: 60182661; 32) MTO HOPKINS LEFT HEART HOWARD CO, Model Number: 60183662; 33) MTS-CARDIOLOGY KIT-HARLINGEN MED, Model Number: 60184001; 34) MTS PERCEPTOR KIT METHODIST. RIC, Model Number: 60185432; 35) MTS LEFT HEART KIT SADDLEBACK ME, Model Number: 60191312; 36) MTS-CARD MAN KIT MARIAN MED CENT, Model Number: 60194273; 37) LEFT HEART KIT SOUTHERN HILLS HO, Model Number: 60195202; 38) MTS DR KHAIRALLAH LEFT HEART KIT, Model Number: 60200189; 39) MTS,4V,DIAG,KIT UNIV OF CONNECTICUT, Model Number: 60210014; 40) MTO L/H KIT-UNIV OF CLEVELAND -, Model Number: 60210047; 41) MTS LEFT HEART KIT-BAPTIST HLTH, Model Number: 60230503; 42) MTS CAN KIT ACCESSOIRE DIAGNOSTI, Model Number: 60700527; 43) MTS LEFT HEART W/SYRINGE-EMORY U, Model Number: 600503712; 44) MTS ACCESSORY KIT SAINT JOSEPH L, Model Number: 601010412; 45) MTS 3 PORT WHITE KIT LEESBURG RE, Model Number: 601222712; 46) MTS PEDS LFT RT HRT-SUNRISE HO, Model Number: 601905414; 47) MTS LHK ST. LOUIS CARDIO INST, Model Number: 606119072; 48) LHK CENTURA HLTH CORP (ST. ANTHO, Model Number: 6010030361; 49) MTS LHK CHAMPLAIN VALLEY, Model Number: 6010128411; 50) MTS LHK VANDERBILT COFFEE HARTON, Model Number: 6019705921; 51) DBD-LHK EPIC SURGERY CENTER LLC, Model Number: 6020410581; 52) DBD-MTS LHK MS HEALTHCARE MGMT, Model Number: 6061073001; 53) LHK - WESLEY MEDICAL CENTER, Model Number: 6010088152A; 54) IR ANGIOGRAPHY PACK-LF, Model Number: DYNJVB1077D; 55) RADIOLOGY SPECIALS TRAY, Model Number: DYNJVB1302B; 56) ANGIO LEFT HEART PACK, Model Number: DYNJ40632D; 57) ANGIO RIGHT HEART PACK, Model Number: DYNJ40633C; 58) ANGIO TRAY, Model Number: DYNJ43278C; 59) CARDIAC LEG PACK, Model Number: DYNJ44065C; 60) EP PACK, Model Number: DYNJ55512A; 61) VASCULAR PACK, Model Number: DYNJ58522A; 62) PERIPHERAL CATH, Model Number: DYNJ59220C; 63) CARDIAC CATH - NO SYR, Model Number: DYNJ62409A; 64) C V MINOR PACK, Model Number: DYNJ64862B; 65) ENDOVASCULAR PACK, Model Number: DYNJ65926

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98599
Lot/product code:
1) 60021775, UDI-DI: 10193489041385(each), 20193489041382(case), Lot Number: 183372; 2) 60021775, UDI-DI: 10193489041385(each), 20193489041382(case), Lot Number: 185190; 3) 60022026, UDI-DI: 10193489087253(each), 20193489087250(case), Lot Number: 106008; 4) 60022026, UDI-DI: 10193489087253(each), 20193489087250(case), Lot Number: 117378; 5) 60022673, UDI-DI: 10193489041538(each), 20193489041535(case), Lot Number: 176180; 6) 60030817, UDI-DI: 10193489041972(each), 20193489041979(case), Lot Number: 185193; 7) 60031245, UDI-DI: 10193489042214(each), 20193489042211(case), Lot Number: 183374; 8) 60031247, UDI-DI: 10193489042238(each), 20193489042235(case), Lot Number: 174370; 9) 60031247, UDI-DI: 10193489042238(each), 20193489042235(case), Lot Number: 184424; 10) 60031247, UDI-DI: 10193489042238(each), 20193489042235(case), Lot Number: 185080; 11) 60031928, UDI-DI: 10193489042276(each), 20193489042273(case), Lot Number: 185195; 12) 60033011, UDI-DI: 10193489042429(each), 20193489042426(case), Lot Number: 181365; 13) 60040273, UDI-DI: 10193489042832(each), 20193489042839(case), Lot Number: 179872; 14) 60040273, UDI-DI: 10193489042832(each), 20193489042839(case), Lot Number: 183375; 15) 60041268, UDI-DI: 10193489043051(each), 20193489043058(case), Lot Number: 140365; 16) 60041268, UDI-DI: 10193489043051(each), 20193489043058(case), Lot Number: 170084; 17) 60050097, UDI-DI: 10193489043242(each), 20193489043249(case), Lot Number: 176186; 18) 60060387, UDI-DI: 10193489043693(each), 20193489043690(case), Lot Number: 183376; 19) 60060387, UDI-DI: 10193489043693(each), 20193489043690(case), Lot Number: 185194; 20) 60060387, UDI-DI: 10193489043693(each), 20193489043690(case), Lot Number: 187370; 21) 60070435, UDI-DI: 10193489044133(each), 20193489044130(case), Lot Number: 183377; 22) 60070435, UDI-DI: 10193489044133(each), 20193489044130(case), Lot Number: 187371; 23) 60070521, UDI-DI: 10193489044164(each), 20193489044161(case), Lot Number: 185196; 24) 60071743, UDI-DI: 10193489044348(each), 20193489044345(case), Lot Number: 176190; 25) 60090078, UDI-DI: 10193489044829(each), 20193489044826(case), Lot Number: 185197; 26) 60090542, UDI-DI: 10193489044867(each), 20193489044864(case), Lot Number: 181373; 27) 60090542, UDI-DI: 10193489044867(each), 20193489044864(case), Lot Number: 185198; 28) 60100071, UDI-DI: 10193489044959(each), 20193489044956(case), Lot Number: 176193; 29) 60100071, UDI-DI: 10193489044959(each), 20193489044956(case), Lot Number: 185189; 30) 60100254, UDI-DI: 10193489045024(each), 20193489045021(case), Lot Number: 185188; 31) 60100439, UDI-DI: 10193489045130(each), 20193489045137(case), Lot Number: 181369; 32) 60100439, UDI-DI: 10193489045130(each), 20193489045137(case), Lot Number: 185203; 33) 60101773, UDI-DI: 10193489045451(each), 20193489045458(case), Lot Number: 181364; 34) 60131099, UDI-DI: 10193489046717(each), 20193489046714(case), Lot Number: 181370; 35) 60131099, UDI-DI: 10193489046717(each), 20193489046714(case), Lot Number: 185204; 36) 60132653, UDI-DI: 10193489047332(each), 20193489047339(case), Lot Number: 181381; 37) 60138326, UDI-DI: 10193489047653(each), 20193489047650(case), Lot Number: 185205; 38) 60160148, UDI-DI: 10193489048704(each), 20193489048701(case), Lot Number: 183382; 39) 60160148, UDI-DI: 10193489048704(each), 20193489048701(case), Lot Number: 185207; 40) 60160428, UDI-DI: 10193489048773(each), 20193489048770(case), Lot Number: 181100; 41) 60161135, UDI-DI: 10193489049046(each), 20193489049043(case), Lot Number: 177936; 42) 60161135, UDI-DI: 10193489049046(each), 20193489049043(case), Lot Number: 185208; 43) 60163618, UDI-DI: 10193489049251(each), 20193489049258(case), Lot Number: 140392; 44) 60181531, UDI-DI: 10193489049619(each), 20193489049616(case), Lot Number: 185209; 45) 60182137, UDI-DI: 10193489049695(each), 20193489049692(case), Lot Number: 185522; 46) 60182137, UDI-DI: 10193489049695(each), 20193489049692(case), Lot Number: 187343; 47) 60182661, UDI-DI: 10193489049794(each), 20193489049791(case), Lot Number: 176203; 48) 60183662, UDI-DI: 10193489050080(each), 20193489050087(case), Lot Number: 181371; 49) 60184001, UDI-DI: 10193489050110(each), 20193489050117(case), Lot Number: 177939; 50) 60184001, UDI-DI: 10193489050110(each), 20193489050117(case), Lot Number: 185210; 51) 60185432, UDI-DI: 10193489050325(each), 20193489050322(case), Lot Number: 184739; 52) 60191312, UDI-DI: 10193489050820(each), 20193489050827(case), Lot Number: 185212; 53) 60194273, UDI-DI: 10193489051094(each), 20193489051091(case), Lot Number: 133064; 54) 60195202, UDI-DI: 10193489051322(each), 20193489051329(case), Lot Number: 181368; 55) 60195202, UDI-DI: 10193489051322(each), 20193489051329(case), Lot Number: 187374; 56) 60200189, UDI-DI: 10193489051513(each), 20193489051510(case), Lot Number: 176208; 57) 60200189, UDI-DI: 10193489051513(each), 20193489051510(case), Lot Number: 181375; 58) 60200189, UDI-DI: 10193489051513(each), 20193489051510(case), Lot Number: 185213; 59) 60210014, UDI-DI:… (truncated, 13411 characters total — see the official FDA record for the full value)
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 25, 2026

Medline Kits: 1) ANGIO CATH PACK-MARY IMMACULAT, Model Number: DYNJ24517D

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98599
Lot/product code:
1) DYNJ24517D, UDI-DI: 10193489812510(each), 40193489812511(case), Lot Number: 25CBA224
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 25, 2026

Medline Kits: 1) ANGIOGRAPHY PACK-LF, Model Number: DYNJQ0505M; 2) ANGIO PACK, Model Number: DYNJT2021G; 3) ANGIOGRAPHY PACK, Model Number: DYNJ31377B; 4) ANGIO PACK, Model Number: DYNJ51279; 5) ANGIOGRAPHY PACK II, Model Number: DYNJ52447; 6) CATH ANGIO PACK, Model Number: DYNJ53369C; 7) ANGIO PACK, Model Number: DYNJ53591A; 8) ANGIOGRAPHIC PACK, Model Number: DYNJ57516; 9) ANGIOGRAPHY TRAY-LF, Model Number: DYNJ58722A; 10) ANGIO TRAY W/CHLORAPREP, Model Number: DYNJ62742; 11) CEREBRAL ANGIOGRAM, Model Number: DYNJ67876; 12) CSU CATH MANIFOLD KIT, Model Number: VASC1170A

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98599
Lot/product code:
1) DYNJQ0505M, UDI-DI: 10889942846900(each), 40889942846901(case), Lot Number: 23KBL880; 2) DYNJQ0505M, UDI-DI: 10889942846900(each), 40889942846901(case), Lot Number: 24ABA125; 3) DYNJQ0505M, UDI-DI: 10889942846900(each), 40889942846901(case), Lot Number: 23IBA898; 4) DYNJT2021G, UDI-DI: 10193489608816(each), 40193489608817(case), Lot Number: 24CMH245; 5) DYNJ31377B, UDI-DI: 10889942106691(each), 40889942106692(case), Lot Number: 25LBQ639; 6) DYNJ31377B, UDI-DI: 10889942106691(each), 40889942106692(case), Lot Number: 25GBF384; 7) DYNJ51279, UDI-DI: 10889942145300(each), 40889942145301(case), Lot Number: 25DBQ486; 8) DYNJ51279, UDI-DI: 10889942145300(each), 40889942145301(case), Lot Number: 25CBT538; 9) DYNJ52447, UDI-DI: 10889942279777(each), 40889942279778(case), Lot Number: 25FMA232; 10) DYNJ53369C, UDI-DI: 10193489651331(each), 40193489651332(case), Lot Number: 25ILA917; 11) DYNJ53369C, UDI-DI: 10193489651331(each), 40193489651332(case), Lot Number: 25FLA554; 12) DYNJ53591A, UDI-DI: 10889942592371(each), 40889942592372(case), Lot Number: 25FBA222; 13) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 21JBN533; 14) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 21KBM563; 15) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 21KBQ110; 16) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 21LBI454; 17) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 23DMF559; 18) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 23EMB053; 19) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 23FME913; 20) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 23JME012; 21) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 24BMK272; 22) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 24CMK043; 23) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 24CMK043Z; 24) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 24DMJ156; 25) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 24FMI064; 26) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 24HMB643; 27) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 24JME212; 28) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 23HME551; 29) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 25DMB495; 30) DYNJ58722A, UDI-DI: 10193489329698(each), 40193489329699(case), Lot Number: 25GBS720; 31) DYNJ62742, UDI-DI: 10193489685923(each), 40193489685924(case), Lot Number: 24KBE607; 32) DYNJ67876, UDI-DI: 10193489449198(each), 40193489449199(case), Lot Number: 25KBP615; 33) VASC1170A, UDI-DI: 10193489774863(each), 40193489774864(case), Lot Number: 23GMC436
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 25, 2026

Medline Namic Guidewires: 1) GUIDEWIRE 3MMJ 0.035X260CM LT, Model Number: DYNJGWIRE20L; 2) GWIRE HYDRO 0.035 180CM ANG S, Model Number: DYNJHWIRE105; 3) GWIRE HYDRO 0.035 260CM ANG S, Model Number: DYNJHWIRE107; 4) GWIRE HYDRO 0.035 260CM STR S, Model Number: DYNJHWIRE115; 5) GWIRE HYDRO 0.035 150CM STR, Model Number: DYNJHWIRE108; 6) GWIRE HYDRO 0.035 150CM ANG S, Model Number: DYNJHWIRE104; 7) GWIRE HYDRO 0.035 180CM STR S, Model Number: DYNJHWIRE113; 8) GWIRE HYDRO 0.035 260CM ANGLE, Model Number: DYNJHWIRE103; 9) GDWIRE .035INX150CM 3MMJ LT, Model Number: DYNJGWIRE01L; 10) GDWIRE .035INX180CM 3MMJ LT, Model Number: DYNJGWIRE03L; 11) GWIRE HYDRO 0.035 150CM STR S, Model Number: DYNJHWIRE112; 12) GWIRE HYDRO 0.035 180CM STR, Model Number: DYNJHWIRE109; 13) GWIRE HYDRO 0.035 210CM ANGLE, Model Number: DYNJHWIRE102; 14) GWIRE HYDRO 0.035 210CM ANG S, Model Number: DYNJHWIRE106; 15) GWIRE HYDRO 0.035 210CM STR, Model Number: DYNJHWIRE110; 16) GWIRE,HYDRO,0.038,180CM,ANG S, Model Number: DYNJHWIRE121; 17) GWIRE HYDRO 0.038 210CM ANG S, Model Number: DYNJHWIRE122; 18) GWIRE HYDRO 0.038 210CM ANGLE, Model Number: DYNJHWIRE118; 19) GWIRE HYDRO 0.038 260CM STR, Model Number: DYNJHWIRE127; 20) GWIRE,HYDRO,0.038,210CM,STR S, Model Number: DYNJHWIRE130; 21) GWIRE,HYDRO,0.038,260CM,ANG S, Model Number: DYNJHWIRE123; 22) GWIRE,HYDRO,0.038",150CM,STR, Model Number: DYNJHWIRE124; 23) GWIRE HYDRO 0.038 150CM ANGLE, Model Number: DYNJHWIRE116; 24) GWIRE,HYDRO,0.038",210CM,STR, Model Number: DYNJHWIRE126; 25) GWIRE HYDRO 0.035 260CM STR, Model Number: DYNJHWIRE111; 26) GWIRE HYDRO 0.035 150CM ANGLE, Model Number: DYNJHWIRE100; 27) GWIRE HYDRO 0.035 180CM ANGLE, Model Number: DYNJHWIRE101; 28) GWIRE,HYDRO,0.038",180CM, STR, Model Number: DYNJHWIRE125; 29) GWIRE HYDRO 0.038 260CM ANGLE, Model Number: DYNJHWIRE119; 30) GWIRE HYDRO 0.038 150CM ANG S, Model Number: DYNJHWIRE120

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98599
Lot/product code:
1) DYNJGWIRE20L, UDI-DI: 10195327188955(each), 40195327188956(case), Lot Number: 34125030001; 2) DYNJGWIRE20L, UDI-DI: 10195327188955(each), 40195327188956(case), Lot Number: 34125040001; 3) DYNJGWIRE20L, UDI-DI: 10195327188955(each), 40195327188956(case), Lot Number: 25DBG562; 4) DYNJGWIRE20L, UDI-DI: 10195327188955(each), 40195327188956(case), Lot Number: 25DBM956; 5) DYNJHWIRE105, UDI-DI: 10195327301637(each), 40195327301638(case), Lot Number: 34124110001; 6) DYNJHWIRE105, UDI-DI: 10195327301637(each), 40195327301638(case), Lot Number: 24LBR925; 7) DYNJHWIRE105, UDI-DI: 10195327301637(each), 40195327301638(case), Lot Number: 25IDB410; 8) DYNJHWIRE107, UDI-DI: 10195327302184(each), 40195327302185(case), Lot Number: 34124110001; 9) DYNJHWIRE107, UDI-DI: 10195327302184(each), 40195327302185(case), Lot Number: 23IBI440; 10) DYNJHWIRE107, UDI-DI: 10195327302184(each), 40195327302185(case), Lot Number: 23KBI254; 11) DYNJHWIRE107, UDI-DI: 10195327302184(each), 40195327302185(case), Lot Number: 24ABQ057; 12) DYNJHWIRE107, UDI-DI: 10195327302184(each), 40195327302185(case), Lot Number: 24ABR513; 13) DYNJHWIRE107, UDI-DI: 10195327302184(each), 40195327302185(case), Lot Number: 24GBL513; 14) DYNJHWIRE107, UDI-DI: 10195327302184(each), 40195327302185(case), Lot Number: 25JDA853; 15) DYNJHWIRE115, UDI-DI: 10195327306021(each), 40195327306022(case), Lot Number: 34124110001; 16) DYNJHWIRE115, UDI-DI: 10195327306021(each), 40195327306022(case), Lot Number: 23BBI300; 17) DYNJHWIRE115, UDI-DI: 10195327306021(each), 40195327306022(case), Lot Number: 24DBT361; 18) DYNJHWIRE115, UDI-DI: 10195327306021(each), 40195327306022(case), Lot Number: 24LBN513; 19) DYNJHWIRE108, UDI-DI: 10195327302191(each), 40195327302192(case), Lot Number: 34124110001; 20) DYNJHWIRE108, UDI-DI: 10195327302191(each), 40195327302192(case), Lot Number: 24DBG409; 21) DYNJHWIRE108, UDI-DI: 10195327302191(each), 40195327302192(case), Lot Number: 24DBI536; 22) DYNJHWIRE108, UDI-DI: 10195327302191(each), 40195327302192(case), Lot Number: 24DBV499; 23) DYNJHWIRE104, UDI-DI: 10195327301620(each), 40195327301621(case), Lot Number: 34124110001; 24) DYNJHWIRE104, UDI-DI: 10195327301620(each), 40195327301621(case), Lot Number: 23BBE325; 25) DYNJHWIRE104, UDI-DI: 10195327301620(each), 40195327301621(case), Lot Number: 24DBF377; 26) DYNJHWIRE104, UDI-DI: 10195327301620(each), 40195327301621(case), Lot Number: 24DBP677; 27) DYNJHWIRE104, UDI-DI: 10195327301620(each), 40195327301621(case), Lot Number: 24EBT215; 28) DYNJHWIRE104, UDI-DI: 10195327301620(each), 40195327301621(case), Lot Number: 24FBB651; 29) DYNJHWIRE104, UDI-DI: 10195327301620(each), 40195327301621(case), Lot Number: 24GBN276; 30) DYNJHWIRE104, UDI-DI: 10195327301620(each), 40195327301621(case), Lot Number: 25JDB022; 31) DYNJHWIRE113, UDI-DI: 10195327306007(each), 40195327306008(case), Lot Number: 34124110001; 32) DYNJHWIRE113, UDI-DI: 10195327306007(each), 40195327306008(case), Lot Number: 23BBI328; 33) DYNJHWIRE113, UDI-DI: 10195327306007(each), 40195327306008(case), Lot Number: 23EBX142; 34) DYNJHWIRE113, UDI-DI: 10195327306007(each), 40195327306008(case), Lot Number: 24CBI166; 35) DYNJHWIRE113, UDI-DI: 10195327306007(each), 40195327306008(case), Lot Number: 24EBB935; 36) DYNJHWIRE103, UDI-DI: 10195327301613(each), 40195327301614(case), Lot Number: 34125010001; 37) DYNJHWIRE103, UDI-DI: 10195327301613(each), 40195327301614(case), Lot Number: 24CBP092; 38) DYNJHWIRE103, UDI-DI: 10195327301613(each), 40195327301614(case), Lot Number: 24GBQ708; 39) DYNJHWIRE103, UDI-DI: 10195327301613(each), 40195327301614(case), Lot Number: 24LBN511; 40) DYNJHWIRE103, UDI-DI: 10195327301613(each), 40195327301614(case), Lot Number: 25IDB409; 41) DYNJGWIRE01L, UDI-DI: 10198459475368(each), 40198459475369(case), Lot Number: 34125030001; 42) DYNJGWIRE01L, UDI-DI: 10198459475368(each), 40198459475369(case), Lot Number: 34125040001; 43) DYNJGWIRE01L, UDI-DI: 10198459475368(each), 40198459475369(case), Lot Number: 25HDB501; 44) DYNJGWIRE01L, UDI-DI: 10198459475368(each), 40198459475369(case), Lot Number: 25JDA596; 45) DYNJGWIRE01L, UDI-DI: 10198459475368(each), 40198459475369(case), Lot Number: 25JDA852; 46) DYNJGWIRE03L, UDI-DI: 10198459475375(each), 40198459475376(case), Lot Number: 34125030001; 47) DYNJGWIRE03L, UDI-DI: 10198459475375(each), 40198459475376(case), Lot Number: 25IDA121; 48) DYNJGWIRE03L, UDI-DI: 10198459475375(each), 40198459475376(case), Lot Number: 25JDA209; 49) DYNJGWIRE03L, UDI-DI: 10198459475375(each), 40198459475376(case), Lot Number: 25JDA844; 50) DYNJGWIRE03L, UDI-DI: 10198459475375(each), 40198459475376(case), Lot Number: 25JDB021; 51) DYNJHWIRE112, UDI-DI: 10195327305994(each), 40195327305995(case), Lot Number: 23BBC807; 52) DYNJHWIRE112, UDI-DI: 10195327305994(each), 40195327305995(case), Lot Number: 23EBF993; 53) DYNJHWIRE112, UDI-DI: 10195327305994(each), 40195327305995(case), Lot Number: 23EBX235; 54) DYNJHWIRE109, UDI-DI: 10195327302207(each), 40195327302208(case), Lot Number: 23BBI326; 55) D… (truncated, 8857 characters total — see the official FDA record for the full value)
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 25, 2026

Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Forceps Model/Catalog Number: PK-CF0533 Product Description: An assembly of devices intended to generate and apply radio-frequency (RF) alternating current to soft tissues for cutting and coagulation during an endoscopic or open surgical procedure.

Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98454
Lot/product code:
Model: PK-CF0533; UDI: 00821925035867; Lot Numbers: All unexpired;
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 25, 2026

Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Catalog Number: 3005 Product Description: The OLYMPUS Everest Bipolar Cutting Forceps are intended to be passed through a 5 mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the bipolar outputs of compatible generators.

Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98454
Lot/product code:
Model: 3005; UDI: 00821925035881; Lot Number: All unexpired
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 25, 2026

2.4 VOLT(TM) TAP CORTEX SCREW TO 90MM. Part Number: 03.424.126-US.

A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8, resulting in the bones taps having an incorrect thread.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98461
Lot/product code:
Part Number: 03.424.126-US. GTIN: 10886982335951. Lot Number: 68982P8.
Recalling firm:
Synthes (USA) Products LLC
View official FDA record (opens in a new tab)