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Recalls affecting Puerto Rico

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

16,258 recalls found
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Just announced

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

Business Pill, Branch Manager for Men — dietary supplements marketed for male sexual enhancement

Products contain undeclared yohimbine

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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 Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

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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. Braun — 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container

Presence of particulate matter identified as iron oxide

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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

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UnclassifiedBacteria/virusE. coliAnnounced September 3, 2026

Great Value — Organic Triple Berry Blend

Possible E. Coli Contamination

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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

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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 Temptations — Chocolatey Eyeballs, 7 oz., 10 oz., 10.5 oz., 11 oz., and 16 oz.

Undeclared milk

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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

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

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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

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UnclassifiedAnnounced August 31, 2026

Kofinas — Garlic Mediterranean Infused Extra Virgin Olive Oil 500 ml, 250 ml, and 100 ml

Contains garlic essential oil not approved for culinary use

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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 Sprouts — Robust Radish Mix, 5oz Cups

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

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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

Martina — Mangoes

Potential contamination with Salmonella

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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

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. BARIATRIC DYNJ905153J DYNJ905153K DYNJ905153L GYNE LAPAROTOMY PACK-LF DYNJ49593A LAPAROSCOPY DYNJ905157G DYNJ905157I DYNJ905157J LAPAROSCOPY PACK DYNJ56930B MAJOR PLUS PACK DYNJ905160J DYNJ905160K DYNJ905160M MINIMALLY INVASIVE PACK-LF DYNJ0843063K PERCUTANEOUS TRAY DYNJ80196 ROBOTIC PACK DYNJ908706 DYNJ908706B

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

Recall #:
99062
Lot/product code:
DYNJ905153J UDI-DI 10193489395464 Lots 21HBD986 21HBO570 21JBK103 21LBC610 22BBV026 22CME902 22GMG562 DYNJ905153K UDI-DI 10195327187866 Lots 22IMF393 22JMG893 23AMG164 23BMB570 DYNJ905153L UDI-DI 10195327405519 Lots 23FME792 23GMD683 23JMF608 23JMG151 DYNJ49593A UDI-DI 10889942275700 Lot 21FBM893 DYNJ46550K UDI-DI 10195327466992 Lot 24CMB215 DYNJ905157G UDI-DI 10193489397420 Lots 21BBG946 21DBD729 21EBO606 21HBN881 21IBE897 21KBA400 21KBO309 21LBC591 21LBG289 22CBV171 22DMI216 22EMH096 22FMC402 22GMG222 22OBE713 DYNJ905157I UDI-DI 10195327219925 Lots 22LMA455 22LMG933 DYNJ905157J UDI-DI 10195327406004 Lots 23GMB987 23IMA700 DYNJ56930B UDI-DI 10193489631289 Lot 24BBD644 DYNJ905160J UDI-DI 10193489908954 Lots 21GBT443 21HBN882 21JBA979 21KBA397 21KBA398 21LBH668 22CBV042 22DMI217 22EMB282 22EME050 22GMG599 22NBB158 DYNJ905160K UDI-DI 10195327187965 Lots 22IMF392 22JME891 22LME862 23AMB124 23AMB378 23AMC123 23BMB201 23BMF724 DYNJ905160M UDI-DI 10195327556723 Lots 23KMD689 23LMC509 24BMA402 DYNJ0843063K UDI-DI 10195327286460 Lots 23ADB394 23BDA963 23CDC020 23EDA191 23FDB421 23HDC666 23JDA179 23LDA280 DYNJ80196 UDI-DI 10195327014469 Lot 25CBK877 DYNJ908706 UDI-DI 10195327154585 Lots 22HMG258 23AMC139 23AME093 23AMH476 23BMF735 DYNJ908706B UDI-DI 10195327556907 Lots 23LMC084 24AMC273 24BMJ061 24CMC665
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. ABDOMINAL VASCULAR-LF DYNJ905291B DYNJ905291C ARTERIOGRAM DYNJ28082G CVICU HEART BAG DYKM2130A ENDOVASCULAR PACK DYNJ0678934J EP PACK DYNJ23456J GENERAL ENDO PACK-LF DYNJ0842873K HYBRID PACK DYNJ65925B DYNJ65925C NON VASCULAR PACK DYNJ68037 PACEMAKER DYNJ901681D PACEMAKER PACK DYNJ51853C DYNJ51853D DYNJ60606A PACER PACK DYNJ40952A RADIOLOGY VASCULAR ACCESS TRAY DYNJVB1303A SM- INTERVENTIONAL DRAPE PK-LF DYNJ0780143K VASCULAR ACCESS PACK-LF DYNJ0101291D VASCULAR DSC DYNJ69172 DYNJ69172B VASCULAR HYBRID DYNJ57543F DYNJ57543I DYNJ57543J VASCULAR PACK DYNJ61702A

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

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

Recall #:
99062
Lot/product code:
DYNJ905291B UDI-DI 10193489950373 Lots 21GBO405 21JBX734 21LBO216 DYNJ905291C UDI-DI 10195327062545 Lots 22BBB434 22CBT553 22CBT556 22FBE950 22GBZ363 22LBQ583 23ABE635 23CBI463 DYNJ28082G UDI-DI 10195327050559 Lots 22BBL073 22DBT712 22FBU975 22IBD336 22LBH042 23BBG319 23CBW711 23EBF014 DYKM2130A UDI-DI 10195327630904 Lot 24ELA817 DYNJ0678934J UDI-DI 10195327637378 Lot 24FMI941 DYNJ23456J UDI-DI 10193489449839 Lot 21BMB927 DYNJ0842873K UDI-DI 10195327286613 Lots 22KDB463 23ADA210 23CDA339 23CDB773 23EDB190 23FDB457 23HDA476 23IDC327 23JDB182 23JDC057 24ADB081 24BDB286 24CDB934 24GDA042 24HDA590 24HDC238 DYNJ65925B UDI-DI 10193489925326 Lots 21FLA630 21GLA415 21HLA270 21JLA166 21KLA318 22CLA057 22CLA817 22DLA206 22ELA964 DYNJ65925C UDI-DI 10195327201371 Lots 23CLB075 23ELA853 23HLA442 23ILA022 DYNJ68037 UDI-DI 10193489473889 Lots 21ABT991 21HBL486 DYNJ901681D UDI-DI 10193489308099 Lot 24EMH538 DYNJ51853C UDI-DI 10193489269000 Lots 21CBB992 21DBA936 21FBE790 21HBN274 21KBA699 21KBP057 DYNJ51853D UDI-DI 10195327101336 Lots 22EBB104 22HBF054 22IBE507 22JBJ069 22KBS971 22LBT245 22NBG258 22OBI766 23ABI851 DYNJ60606A UDI-DI 10193489693386 Lot 24BBA469 DYNJ40952A UDI-DI 10193489941906 Lots 21GBR992 21JBX464 22BBS266 22CBP195 22EBS044 DYNJVB1303A UDI-DI 10193489928358 Lots 23ELB088 23FLA355 DYNJ0780143K UDI-DI 10195327477240 Lot 24AMI797 DYNJ0101291D UDI-DI 10193489381931 Lots 21CDC066 21EDB518 21GDC932 21HDC814 22BDA495 22DDB731 22DDC457 22EDB642 22GDA964 22JDA001 22JDC181 DYNJ69172 UDI-DI 10193489899603 Lots 21GMA692 21IMH791 DYNJ69172B UDI-DI 10195327487027 Lot 23KMC637 DYNJ57543F UDI-DI 10195327279028 Lot 23AMF931 DYNJ57543I UDI-DI 10195327359362 Lot 23CMD266 DYNJ57543J UDI-DI 10195327416027 Lots 23GMD945 23GMG266 DYNJ61702A UDI-DI 10193489470321 Lots 21CBN901 21FBM858 21GBE705
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 Control Syringe, labeled as follows: 1. SYRINGE,7ML,TR/FR,RA,W/RES,-,P/G, Medline SKU 70083007; 2. SYRINGE,8ML,TR/FR,RA,W/RES,-,P/G, Medline SKU 70084007; 3. MTS,SYRINGE,8ML,TR/FR,RA,NO,RES,-,P/G, Medline SKU 70084017; 4. SYRINGE,7,ML,TR/FR,RA,W/RES,OEM,PG, Medline SKU 80083007; 5. SYRINGE,8,ML,TR/FR,RA,W/RES,OEM,PG, Medline SKU 80084007; 6. MTO,SYRINGE,8,ML,TR/FR,RA,NO,RES,OEM,PG, Medline SKU 80084017.

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:
1. Medline SKU 70083007, UDI/DI each 10193489065855, UDI/DI case 30193489065859, Lot Numbers: 0000077029, 0000081537, 0000084335, 0000087347, 0000089563, 0000113792, 0000115753, 0000122956, 0000127785, 0000131986, 0000158748, 0000175535, 0000187926; 2. Medline SKU 70084007, UDI/DI each 10193489065893, UDI/DI case 30193489065897, Lot numbers: 0000078186, 0000081539, 0000084274, 0000086756, 0000089554, 0000094842, 0000096918, 0000105613, 0000109479, 0000111244, 0000114562, 0000115421, 0000117317, 0000118251, 0000120265, 0000120769, 0000121714, 0000123466, 0000124589, 0000131984, 0000131989, 0000138071, 0000140322, 0000142850, 0000147002, 0000152069, 0000162694, 0000173507, 0000174662, 0000174773, 0000176555, 0000178806, 0000189895; 3. Medline SKU 70084017, UDI/DI each 10193489065916, UDI/DI case 20193489065913, Lot Numbers: 0000084509, 0000086823, 0000095687, 0000165551, 0000165868, 0000166300; 4. Medline SKU 80083007, UDI/DI each 10193489066753, UDI/DI case 30193489066757, Lot Numbers: 0000097388, 0000127072, 0000135012, 0000137004; 5. Medline SKU 80084007, UDI/DI each 10193489066791, UDI/DI case 30193489066795, Lot Numbers: 0000080553, 0000080919, 0000082969, 0000085041, 0000088044, 0000094514, 0000099870, 0000101882, 0000102372, 0000105155, 0000107328, 0000109442, 0000112810, 0000112966, 0000114317, 0000115744, 0000117572, 0000118722, 0000118962, 0000119950, 0000120931, 0000121305, 0000121393, 0000122583, 0000122606, 0000123102, 0000126198, 0000126566, 0000127132, 0000130798, 0000131678, 0000132838, 0000137176, 0000139543, 0000140507, 0000142057, 0000142279, 0000143110, 0000143264, 0000143714, 0000148872, 0000150059, 0000150488, 0000151054, 0000151295, 0000151300, 0000151768, 0000152754, 0000153438, 0000154148, 0000156028, 0000158045, 0000158122, 0000159113, 0000159652, 0000160479, 0000160753, 0000161269, 0000162083, 0000162090, 0000162336, 0000162895, 0000164540, 0000164541, 0000166504, 0000166983, 0000167995, 0000168000, 0000169147, 0000169560, 0000169793, 0000170823, 0000171778, 0000173402, 0000174087, 0000174697, 0000174747, 0000176011, 0000176240, 0000176850, 0000177923, 0000179193, 0000179414, 0000180511, 0000182186, 0000182779, 0000182782, 0000185643, 0000186234, 0000186874, 0000187362, 0000187363, 0000188837, 0000188842, 0000188845; 6. Medline SKU 80084017, UDI/DI each 10193489066814, UDI/DI case 20193489066811, Lot Numbers: 0000101535, 0000103862, 0000105095, 0000106954, 0000108237, 0000122887, 0000126590, 0000127159, 0000128360, 0000128852, 0000132717, 0000134047, 0000135616, 0000140813, 0000144899, 0000148530, 0000149322, 0000152430, 0000161279, 0000164538, 0000169107, 0000173193, 0000173256, 0000182141, 0000183619, 0000187345, 0000188399.
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. CSTM MANIFOLD KIT - TITUS, Medline SKU VASC1061; 2. CSTM MANIFOLD KIT - FRYE, Medline SKU VASC1074; 3. CRYO EP MANIFOLD KIT, Medline SKU VASC1198; 4. MANIFOLD KIT - 500PSI OFF, Medline SKU VASCSHPOFF1; 5. MANIFOLD KIT LOW PRESSURE ON, Medline SKU VASCSLPON1.

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 VASC1061, UDI/DI each 10889942464722, UDI/DI case 40889942464723, Lot Number 25IBN161; Medline SKU VASC1061, UDI/DI each 10889942464722, UDI/DI case 40889942464723, Lot Number 25GBF769; Medline SKU VASC1074, UDI/DI each 10889942611751, UDI/DI case 40889942611752, Lot Number 25HBN798; Medline SKU VASC1074, UDI/DI each 10889942611751, UDI/DI case 40889942611752, Lot Number 25GBL527; Medline SKU VASC1198, UDI/DI each 10193489664263, UDI/DI case 40193489664264, Lot Number 25GDA142; Medline SKU VASCSHPOFF1, UDI/DI each 10889942405503, UDI/DI case 40889942405504, Lot Number 25IBP989; Medline SKU VASCSHPOFF1, UDI/DI each 10889942405503, UDI/DI case 40889942405504, Lot Number 25GBL526; Medline SKU VASCSLPON1, UDI/DI each 10889942405510, UDI/DI case 40889942405511, Lot Number 25GBL070.
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: CVOR ANGIOGRAPHY PACK-LF, Medline SKU DYNJ42367B

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 DYNJ42367B UDI/DI each 10193489211511, UDI/DI case 40193489211512, Lot Numbers: 24FBJ579, 24DBL828, 24DBE055, 24CBG967, 24ABN254, 23LBI540, 23KBF222, 23JBM761, 23JBA270, 23HBY791, 23HBD212, 23GBJ794, 23FBK893, 23EBQ313, 23DBC465.
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 Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes E P DRAPE PACK-LF DYNJ0373061J

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:
DYNJ0373061J UDI-DI 10889942396856 (EA) 40889942396857 (CS) LOT 24ABR895
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 medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. SHOULDER ARTHROSCOPY PACK, Medline SKU # DYNJ30880M; 2. EXTREMITY PACK, Medline SKU # DYNJ64295A.

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.

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

Recall #:
98598
Lot/product code:
1. Medline SKU # DYNJ30880M, UDI/DI each 10198459446207, UDI/DI case 40198459446208, Lot Number: 25LMJ532; 2. Medline SKU # DYNJ64295A, UDI/DI each 10193489353853, UDI/DI case 40193489353854, Lot Number: 24KMI274.
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 EYE PACK DYNJ35056A HEART CATH PACK DYNJ69318A

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:
DYNJ35056A UDI-DI 10889942227563 (EA) 40889942227564 (CS) LOT 24ABN639 DYNJ69318A UDI-DI 10195327370756 (EA) 40195327370757 (CS) LOTS 23DMD456 23EMB847 23HMB969 23IMC364 23JME011 23JMI841 23LMC384 24BMD333 24CMB768 24CMJ586 24EMJ527 24GMD970 24JMB408 24JMI594 24KMC774 ***Updated 5/20/26 - The following lots were included in the customer letter but not the FDA submission.*** DYNJ69318A lots 23FMA845 23FMA924 25BMF603
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. KIT NEURO CSTM SAMP0551

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

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

Recall #:
99062
Lot/product code:
SAMP0551 UDI-DI 10195327268503 Lots 22JBG593 22JBJ361
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.

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▸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

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BARIATRIC DYNJ905153M, DYNJ905153N GENERAL LAPAROSCOPY PACK DYNJ81602 LAPAROSCOPY DYNJ905157K, DYNJ905157L LAPAROTOMY PACK DYNJ46675G MAJOR LITHOTOMY PACK DYNJ81607 MAJOR PLUS PACK DYNJ905160O MINOR GENERAL PACK DYNJ81599

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:
DYNJ905153M UDI-DI 10195327556761 (EA) 40195327556762 (CS) LOT 24CMG485 DYNJ905153N UDI-DI 10198459017797 (EA) 40198459017798 (CS) LOT 25DMC254 DYNJ81602 UDI-DI 10195327123857 (EA) 40195327123858 (CS) LOT 24ABP080 DYNJ905157K UDI-DI 10195327556921 (EA) 40195327556922 (CS) LOTS 24DMF349 24EMC297 DYNJ905157L UDI-DI 10198459017711 (EA) 40198459017712 (CS) LOTS 24FMD083 24HMD400 24IME332 24JMA234 24KMG588 25AMA393 25AMJ541 25BMI202 25CMD909 25CMH371 DYNJ46675G UDI-DI 10195327419066 (EA) 40195327419067 (CS) LOT 24ABS814 DYNJ81607 UDI-DI 10195327123918 (EA) 40195327123919 (CS) LOT 24ABP097 DYNJ905160O UDI-DI 10198459017742 (EA) 40198459017743 (CS) LOTS 24HMG093 24IME714 24JMI924 24LMB556 25AME613 25BMJ076 DYNJ81599 UDI-DI 10195327124021 (EA) 40195327124022 (CS) LOT 24BBB847 ***Updated 5/20/26 - The following lots were included in the customer letter but not in the FDA submission.*** DYNJ905153M lots 24BMH968 24EMG682; DYNJ905153N lots 24HMG087 24IMA442 24IMG245; DYNJ905157K lots 23LME674 24AMH261 24AMJ205 24BME886 24CMD057
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 Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BASIC CL PACK-LF DYNJ87052 BASIC PACK DYNJ83976 BASIC SET UP PACK DYNJ80700 CORONARY ANGIOGRAPHY PACK (N) DYNJ42136B CSTM ANGIO KIT - S VASC1109 CV PACK DYNJ46301C DR F PACK DYNJ41253B ENSEMBLE HEMORROIDES DYNJ56311A G TAVR PACK DYNJ61006 IR MINOR PACK DYNJ44139C MAJOR PLUS PACK DYNJ905160N MAXIMUM BARRIER BUNDLE PACK DYNJ35216C PCI PACK TBRHSC-LF DYNJ41941D PERC PACK-LF DYNJ0774759P PERIPHERAL ANGIOGRAPHY PK DYNJ42094B PROCEDURE PACK DYNJ55063B PTCA PACK DYNJ55359B ROBOTIC PACK DYNJ908706C SPECIAL PROCEDURES TRAY DYNJ41174A SYRINGE WIRE KIT SANFORD SAMPC0644 WPH EP PACK DYNJ62745 X-RAY PACK DYNJ44295G

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:
DYNJ87052 UDI-DI 10198459005121 (EA) 40198459005122 (CS) LOTS 24FLA345 24FLA915 24HLB029 DYNJ83976 UDI-DI 10195327323196 (EA) 40195327323197 (CS) LOTS 24ABO128 DYNJ80700 UDI-DI 10195327066925 (EA) 40195327066926 (CS) LOTS 24BBD119 DYNJ42136B UDI-DI 10889942825288 (EA) 40889942825289 (CS) LOTS 23EMC679 24BMC063 24BMF939 24DMH398 24FMB963 24GMH870 24HMI957 24JMB273 24KMI914 VASC1109 UDI-DI 10889942779079 (EA) 40889942779070 (CS) LOTS 20EBW196 20FBR136 20HBV757 20JBC396 21ABE357 21ABT166 21BBN949 21CBS148 21EBB385 21KBD389 21LBD078 22BBV291 22DBN021 22EBO307 22GBZ351 22JBD956 23FBJ696 23HBR604 23IBF895 24JBK913 24KBR194 DYNJ46301C UDI-DI 10193489527889 (EA) 40193489527880 (CS) LOT 23LMH904 DYNJ41253B UDI-DI 10888277958173 (EA) 40888277958174 (CS) LOT 24ABP897 DYNJ56311A UDI-DI 10193489360127 (EA) 40193489360128 (CS) LOT 24ABR871 DYNJ61006 UDI-DI 10193489546194 (EA) 40193489546195 (CS) LOTS 21FBT962 21HBE414 21JBK356 21LBU392 22HBH070 22IBD976 22OBF481 23ABS489 23BBT198 23EBR237 23GBH211 23IBP468 23JBC690 23KBJ782 23LBT261 24BBQ276 24DBG218 24EBQ703 24GBE940 24IBD970 24JBA173 24KBQ943 DYNJ44139C UDI-DI 10193489226102 (EA) 40193489226103 (CS) LOTS 21EBS091 21GBI562 21HBR793 21IBX717 21KBJ549 22ABH554 22BBM456 22DBS762 22FBJ076 22FBR590 22IBB384 22KBF481 22LBB630 22OBG108 23ABJ826 23BBO865 23CBR417 23DBN752 23EBV786 23GBR439 23IBE449 23IBU640 23KBJ599 23LBP229 24ABC062 24EMG282 24IMC574 DYNJ905160N UDI-DI 10195327664473 (EA) 40195327664474 (CS) LOTS 24DMC432 24EMG685 DYNJ35216C UDI-DI 10889942952618 (EA) 40889942952619 (CS) LOTS 22GDA210 24IDA943 24KDA980 24LDA479 DYNJ41941D UDI-DI 10193489753707 (EA) 40193489753708 (CS) LOTS 20ABB748 20ABV122 20BBA524 20CBN068 20EBG674 20FBD191 20HBS587 20JBT996 21ABI859 21ABJ490 21BBD481 21CBH747 21DBH332 21JBE257 21JBU827 21LBR129 22CBZ848 22FBK880 22IBT430 22KBT522 22OBG445 23BBB312 23CBR316 23DBO494 23GBQ439 23HBM965 23HBX738 23IBU090 23JBV457 23LBF066 23LBT768 24CBG494 24DBG816 24EBC719 24JBF955 24KBD843 DYNJ0774759P UDI-DI 10195327246136 (EA) 40195327246137 (CS) LOT 24DMH153 DYNJ42094B UDI-DI 10889942820849 (EA) 40889942820840 (CS) LOTS 24CDA087 24EDA493 24HDA294 24IDA278 24IDB151 24IME505 24JMF227 24KMC897 24LME897 DYNJ55063B UDI-DI 10195327538972 (EA) 40195327538973 (CS) LOT 24ABP065 DYNJ55359B UDI-DI 10193489235517 (EA) 40193489235518 (CS) LOTS 23DBI651 23FBR555 23GBK876 23HBC455 23IBC298 23KBN808 24BBO002 24DBG256 24DBQ490 24EBJ876 24GBO458 DYNJ908706C UDI-DI 10195327664497 (EA) 40195327664498 (CS) LOT 24EMG687 DYNJ41174A UDI-DI 10195327366254 (EA) 40195327366255 (CS) LOT 23JBK389 SAMPC0644 UDI-DI 10193489356885 (EA) 40193489356886 (CS) LOT 20FDA159 DYNJ62745 UDI-DI 10193489688160 (EA) 40193489688161 (CS) LOT 24ABQ796 DYNJ44295G UDI-DI 10195327431273 (EA) 40195327431274 (CS) LOT 24IBH033 ***Updated 5/20/26 - The following lots were included in the customer letter but not the FDA submission.*** DYNJ35216C lots 21BDA005 21CDA164 21DDB532 21IDA938 21KDB822 22ADB494 22ADC166 22CDB658 22DDC504 22HDA355 22LDA336 23BDB027 23BDC034 23DDA002 23DDA917 23GDA443 23HDA139 23JDC163 23LDA319 24DDA760 24GDA206 24GDB408 25BDA073 25DDA617 25DDB847; DYNJ41941D lots 24LBU189 25EBO278; DYNJ42094B lots 21DDA142 21EDA157 21FDA721 21HDC553 21JDB308 21KDC411 22ADB304 22DDA696 22EDB388 22GDB457 22HDC130 22KDB833 23ADA446 23BDB104 23DDA367 23EDA799 23FDB379 23HDB674 23KDA291 23KDC457 24ADA586 25DMB689 25EMH157; DYNJ42136B lots 20XBH732 21FBD068 21FBP137 21GBM895 21IBO938 21JBW334 21LBK626 22DBB070 22DBT749 22DBT751 22GBL802 22KMB909 23AMA925 23AMA926 23DMC128 23EMK206 23FMD274 23GMI199 23IMF729 23KMG485 25DMG003 25EMJ002; DYNJ44139C lots 21ABF720 21BBP639 21OBA387 DYNJ46301C 23EMD296; DYNJ55359B lots 21CBY049 21HBJ347 21KBK603 21LBU329 22BBN805 22DBG945 22DBG946 22EBI619 22EBI620 22GBV248 22IBD917 22JBP712 22KBO285 22LBF294 23BBN404 23CBU106; DYNJ61006 lots 21BBM590 21DBE579 25EBA174; DYNJ62745 lots 21CBZ899 21EBI827 21HBB755 21KBR329 21LBP817 22BBB761 22BBY454 22FBG531 22FBG532 22GBH888 22HBH100 22JBS334 23ABF660 23BBR901 23DBC087 23EBN460 23FBQ453 23GBH068 23IBB014 23JBP276 23LBJ141 24BBR785 24BBS830; VASC1109 lots 25BBR047
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 FACE/RHINOPLASTY PACK DYNJ80343C PLASTIC HEAD-NECK PACK DYNJ86639

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:
DYNJ80343C UDI-DI 10195327507299 (EA) 40195327507290 (CS) LOT 24ABO127 DYNJ86639 UDI-DI 10195327661922 (EA) 40195327661923 (CS) LOT 24FBM972
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 GU DAVINCI PACK - LF DYNJ909398A ROBOTIC PACK DYNJ908706D

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

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

Recall #:
98601
Lot/product code:
DYNJ909398A UDI-DI 10195327338190 (EA) 40195327338191 (CS) LOTS 24GMH510 24HMG886 DYNJ908706D UDI-DI 10198459017773 (EA) 40198459017774 (CS) LOTS 24HMA783 24HMG308 24KMC651 24KMJ274 24LME931 25AME217 25BMI653 ***Updated 5/20/26 - The following lots were included in the customer letter but not in the FDA submission.*** DYNJ909398A lots 23EMF078 23HME512 23HMI269 23JMB528 23KME175 24EMC327
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. ANGIO PACK DYNJ30565C DYNJ32555B ANGIO PACK-LF DYNJ0774765U ANGIO TRAY DYNJ46153A ANGIOGRAM TRAY DYNJ33638K ANGIOGRAPHY DRAPE PK QVH-LF DYNJ35110D ANGIOGRAPHY PACK DYNJ44293D ANGIOGRAPHY PACK-LF DYNJ0854485T DYNJ35916J GENERAL ANGIO PACK DYNJ57760B GENERAL ENDO PACK-LF DYNJ0842873J JUDKINS PACK DYNJ51126A RADIOLOGY ANGIO MAJOR PACK DYNJ62858B TAVR JUDKINS PACK DYNJ51127B

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

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

Recall #:
99062
Lot/product code:
DYNJ30565C UDI-DI 10889942165704 Lots 21CDA555 21DDA970 DYNJ32555B UDI-DI 10884389648216 Lot 21AMA053 DYNJ0774765U UDI-DI 10193489634594 Lot 21FLA468 DYNJ46153A UDI-DI 10889942185863 Lots 20XBH471 21BBC325 DYNJ33638K UDI-DI 10193489343281 Lot 21HLA726 DYNJ35110D UDI-DI 10193489329940 Lot 21IMC537 DYNJ44293D UDI-DI 10193489833416 Lots 21CBE250 21CBX084 21FBB546 21HBD075 21KBN509 22ABV463 22BBX022 22DBJ641 22HBB710 22HBT960 22IBD236 22OBF392 DYNJ0854485T UDI-DI 10193489864199 Lots 21FBC416 21GBL506 21IBO920 21JBS587 DYNJ35916J UDI-DI 10193489838404 Lots 21CBF463 21DBP668 21DBR247 DYNJ57760B UDI-DI 10193489342581 Lots 21CME104 21EME408 21FMD506 21GMG028 21JMF774 21KMH487 DYNJ0842873J UDI-DI 10193489448917 Lots 21ADA204 21CDB566 21EDB709 21GDC532 21HDC041 21JDB401 21JDC566 21LDA726 22BDA893 22CDC138 22EDA075 22FDC040 22HDB149 22JDA080 DYNJ51126A UDI-DI 10193489854886 Lots 21DDA694 21EDB249 21GDD164 21IDA472 21KDA815 DYNJ62858B UDI-DI 10193489891263 Lots 21FMF601 21HMF637 21HMG835 21JMF531 DYNJ51127B UDI-DI 10193489854893 Lot 22FBV791
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. CATH LAB PACK-LF, Medline SKU 00-HCT055P; 2. INTERVENTIONAL CATH LAB PK-LF, Medline SKU DYNJ0376230Q; 3. ANGIOGRAPHY CATH LAB, Medline SKU DYNJ23532C; 4. ANGIO LEFT HEART PACK, Medline SKU DYNJ40632C; 5. ANGIO DRAPE PACK, Medline SKU DYNJ47952B; 6. ANGIOGRAPHIC PACK, Medline SKU DYNJ57516; 7. CATH LAB PACK, Medline SKU DYNJ58243B; 8. CATH LAB PACK, Medline SKU DYNJ65185; 9. CSU CATH MANIFOLD KIT, Medline SKU VASC1170A; 10. MANIFOLD KIT NO TRANSDUCER, Medline SKU VASC1184A.

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.

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

Recall #:
98598
Lot/product code:
Medline SKU 00-HCT055P, UDI/DI each 10193489297393, UDI/DI case 40193489297394, Lot Number 24BBI341; Medline SKU 00-HCT055P, UDI/DI each 10193489297393, UDI/DI case 40193489297394, Lot Number 23LBP066; Medline SKU 00-HCT055P, UDI/DI each 10193489297393, UDI/DI case 40193489297394, Lot Number 23KBS305; Medline SKU 00-HCT055P, UDI/DI each 10193489297393, UDI/DI case 40193489297394, Lot Number 23JBA062; Medline SKU 00-HCT055P, UDI/DI each 10193489297393, UDI/DI case 40193489297394, Lot Number 23HBR594; Medline SKU 00-HCT055P, UDI/DI each 10193489297393, UDI/DI case 40193489297394, Lot Number 23DBR051; Medline SKU DYNJ0376230Q, UDI/DI each 10193489759303, UDI/DI case 40193489759304, Lot Number 24ABO014; Medline SKU DYNJ0376230Q, UDI/DI each 10193489759303, UDI/DI case 40193489759304, Lot Number 23KBW878; Medline SKU DYNJ0376230Q, UDI/DI each 10193489759303, UDI/DI case 40193489759304, Lot Number 23HBP761; Medline SKU DYNJ0376230Q, UDI/DI each 10193489759303, UDI/DI case 40193489759304, Lot Number 23FBW006; Medline SKU DYNJ0376230Q, UDI/DI each 10193489759303, UDI/DI case 40193489759304, Lot Number 23DBF403; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 25KMD905; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 25IMD215; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 25GMI326; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 25FMI653; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 25EMH566; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 25DMI277; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 25AMI608; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24LMH838; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24LMB458; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24JME629; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24GME647; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24GMB984; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24GMB351; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24EMF938; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24DMH385; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24CMH336; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24CMF956; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24BMA898; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24AMA108; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 23HMH132; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 23GMH036; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 23GME698; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 23FMF802; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 23EMJ218; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 24JMD976; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 24HMA010; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 24GMG026; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 24GMB098; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 24FMF601; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 24EMB438; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 24BMA764; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 23LME233; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 23JMH698; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 23IMD171; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 23GMD850; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 23FMF778; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 23EMG560; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 25L… (truncated, 10705 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

Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

Multi-parameter command module has a circuit board issue and when in Auto mode, Cardiac Output (CO) measurement may activate early, resulting in Bad Curve error with no CO measurement or Irregular Curve error with CO measurement not automatically excluded, which may result in inaccurate readings, or the need of additional readings, which may lead to delayed care and/or fluid overload.

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

Recall #:
98374
Lot/product code:
Serial Numbers: UDI-DI: 10841522106415, 10841522106422. 1496-223736, 1496-223737, 1496-223738, 1496-224375, 1496-224376, 1496-224400, 1496-224401, 1496-224402, 1496-224403, 1496-224404, 1496-224405, 1496-224406, 1496-223850, 1496-223851, 1496-223852, 1496-224448, 1496-224956, 1496-224957, 1496-224958, 1496-224959, 1496-224960, 1496-224961, 1496-224981, 1496-224258, 1496-223595, 1496-223596, 1496-223597, 1496-223598, 1496-223619, 1496-223620, 1496-223621, 1496-223622, 1496-223623, 1496-223624, 1496-224717, 1496-224718, 1496-223854, 1496-224373, 1496-224374, 1496-223894, 1496-223895, 1496-223896, 1496-223897, 1496-223898, 1496-223899, 1496-223900, 1496-223901, 1496-223902, 1496-223903, 1496-223904, 1496-223905, 1496-223906, 1496-223907, 1496-223918, 1496-225043, 1496-225044, 1496-225045, 1496-225046, 1496-225047, 1496-225048, 1496-225049, 1496-225050, 1496-225051, 1496-225052, 1496-225053, 1496-225054, 1496-225055, 1496-225056, 1496-225057, 1496-225058, 1496-225059, 1496-225060, 1496-225061, 1496-225062, 1496-225063, 1496-225064, 1496-225065, 1496-225066, 1496-225067, 1496-225068, 1496-224949, 1496-223760, 1496-223761, 1496-225154, 1496-224639, 1496-224719, 1496-224720, 1496-224721, 1496-225088, 1496-225089, 1496-224672, 1496-223908, 1496-223909, 1496-223910, 1496-223911, 1496-223912, 1496-223913, 1496-223914, 1496-223915, 1496-223916, 1496-223917, 1496-224637, 1496-224638, 1496-224752, 1496-224744, 1496-224745, 1496-224746, 1496-224747, 1496-224407, 1496-224408, 1496-224409, 1496-224410, 1496-224411, 1496-224412, 1496-224413, 1496-224414, 1496-224415, 1496-224416, 1496-224417, 1496-224418, 1496-224419, 1496-224420, 1496-224421, 1496-224753, 1496-224754, 1496-224755, 1496-224756, 1496-224757, 1496-225129, 1496-223825, 1496-223826, 1496-223829, 1496-223830, 1496-223831, 1496-223832, 1496-223833, 1496-223834, 1496-223835, 1496-223836, 1496-223837, 1496-223838, 1496-223839, 1496-222928, 1496-222929, 1496-223774, 1496-223775, 1496-224063, 1496-224064, 1496-223580, 1496-223618, 1496-223313, 1496-223314, 1496-223315, 1496-223316, 1496-223317, 1496-223318, 1496-223319, 1496-223320, 1496-223321, 1496-223322, 1496-223323, 1496-223325, 1496-223326, 1496-223327, 1496-223328, 1496-223330, 1496-223331, 1496-223332, 1496-223333, 1496-223334, 1496-223335, 1496-223336, 1496-223337, 1496-223338, 1496-223339, 1496-223340, 1496-223341, 1496-223342, 1496-223419, 1496-223420, 1496-223421, 1496-223422, 1496-223423, 1496-223424, 1496-223425, 1496-223426, 1496-223427, 1496-223428, 1496-223429, 1496-223430, 1496-223431, 1496-223432, 1496-223433, 1496-223434, 1496-223435, 1496-223436, 1496-223437, 1496-223438, 1496-223439, 1496-223440, 1496-223441, 1496-223442, 1496-223443, 1496-223444, 1496-223445, 1496-223446, 1496-223447, 1496-223448, 1496-223449, 1496-223450, 1496-223451, 1496-223452, 1496-223453, 1496-223454, 1496-223455, 1496-223456, 1496-223457, 1496-223458, 1496-223459, 1496-223460, 1496-223461, 1496-223462, 1496-223463, 1496-223464, 1496-223465, 1496-223466, 1496-223467, 1496-223468, 1496-223469, 1496-223470, 1496-223471, 1496-223472, 1496-223473, 1496-223474, 1496-223475, 1496-223476, 1496-223477, 1496-223478, 1496-223479, 1496-223480, 1496-223481, 1496-223482, 1496-223483, 1496-223484, 1496-223485, 1496-223486, 1496-223487, 1496-223488, 1496-223489, 1496-223490, 1496-223491, 1496-223492, 1496-223493, 1496-223494, 1496-223495, 1496-223496, 1496-223497, 1496-223498, 1496-223499, 1496-223500, 1496-223501, 1496-223502, 1496-223503, 1496-223504, 1496-223505, 1496-223506, 1496-223507, 1496-223508, 1496-223509, 1496-223510, 1496-223511, 1496-223512, 1496-223513, 1496-223514, 1496-223515, 1496-223516, 1496-223517, 1496-223518, 1496-223519, 1496-223520, 1496-223521, 1496-223522, 1496-223523, 1496-223524, 1496-223525, 1496-223526, 1496-223527, 1496-223528, 1496-223529, 1496-223530, 1496-223531, 1496-223532, 1496-223533, 1496-223534, 1496-223535, 1496-223536, 1496-223537, 1496-223538, 1496-223539, 1496-223540, 1496-223541, 1496-223542, 1496-223543, 1496-223544, 1496-223545, 1496-223546, 1496-223547, 1496-224427, 1496-224428, 1496-224449, 1496-224450, 1496-224451, 1496-224452, 1496-224453, 1496-224454, 1496-224455, 1496-224456, 1496-224457, 1496-224458, 1496-224459, 1496-224460, 1496-224461, 1496-224462, 1496-224463, 1496-224464, 1496-224465, 1496-224466, 1496-224467, 1496-224468, 1496-224469, 1496-224470, 1496-224471, 1496-224472, 1496-224473, 1496-224474, 1496-224475, 1496-224476, 1496-224477, 1496-224478, 1496-224479, 1496-224480, 1496-224481, 1496-224482, 1496-224483, 1496-224484, 1496-224485, 1496-224486, 1496-224487, 1496-224488, 1496-224489, 1496-224490, 1496-224491, 1496-224492, 1496-224493, 1496-224494, 1496-224495, 1496-224496, 1496-224497, 1496-224498, 1496-224499, 1496-224500, 1496-224501, 1496-224502, 1496-224503, 1496-224504, 1496-224505, 1496-224506, 1496-224507, 1496-224508, 1496-224509, 1496-224510, 1496-224511, 1496-224512, 1496-224513, 1496-224514, 1496-224515, 1496-224516, 1496-224517, 1496-224518, 1496-224519, 1496… (truncated, 23324 characters total — see the official FDA record for the full value)
Recalling firm:
Spacelabs Healthcare, Inc.
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

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ENSEMBLE GYNECO SCOPIE-LF DYNJ53744B LAVH GRH-LF DYNJ41792G

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:
DYNJ53744B UDI-DI 10193489761689 (EA) 40193489761680 (CS) LOT 24ABS765 DYNJ41792G UDI-DI 10195327547127 (EA) 40195327547128 (CS) LOT 24ABT556
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

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

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BIOPSY PACK DYNJ38587A, DYNJ38587B BIOPSY/DRAINAGE TRAY-LF DYNJ30078D W LINQ PACK DYNJ59108B

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:
DYNJ38587A UDI-DI 10193489754070 (EA) 40193489754071 (CS) LOTS 20BBF696 20EBH917 20FBW435 20HBM667 20JBF107 20KBW292 20LBS930 21EBB195 21FBR610 21GBS936 21GBS940 21JBU912 21KBP999 22ABX182 22EBI922 22GBZ788 22JBL031 23BBN160 DYNJ38587B UDI-DI 10195327397326 (EA) 40195327397327 (CS) LOTS 23DBP789 23FBM124 23HBW639 23JBN841 24ABG236 24CBM867 24FME120 24JMD066 24LME187 DYNJ30078D UDI-DI 10889942138647 (EA) 40889942138648 (CS) LOTS 23CBK546 23FBQ481 23IBQ435 23JBR634 23LBG856 24ABE287 24BBS264 24EBQ336 24GBJ987 24JBO830 DYNJ59108B UDI-DI 10198459138461 (EA) 40198459138462 (CS) LOT 24JBP861 ***Updated 5/20/26 - The following lots were included in the customer communication but not in the FDA submission.*** DYNJ30078D Lots 21EBD861 21IBM130 21IBV938 21IBV939 21IBV940 21LBB809 22ABZ810 22BBV614 22FBL865 22IBE477 22JBH508 22KBJ437 22OBC310 23BBT881 23EBK298; DYNJ38587B Lots 25BMB873; DYNJ59108B Lots 24LBT539
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)