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Recalls affecting Maryland

Data last updated: September 11, 2026 at 1:08 PM UTC

16,861 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.

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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

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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 January 7, 2026

Medline Convenience Kits: 1) PICC CATHETER INSERTION TRAY, Model Number: CVI4300; 2) OSC SHERMAN KNEE ARTHRO BASIC, Model Number: DYKM1977C; 3) KIT ACES INSERT PEG, Model Number: DYKMBNDL130; 4) KIT ACES INSERT PEG, Model Number: DYKMBNDL130A; 5) KIT ACES INSERT PERCUTANEOUS T, Model Number: DYKMBNDL4; 6) NICU LINE CHANGE TRAY, Model Number: LC295

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

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

Recall #:
98642
Lot/product code:
1) CVI4300, UDI-DI: 10653160294313(each), 653160294316(case), Lot Number: 2020120950; 2) DYKM1977C, UDI-DI: 10653160381105(each), 653160381108(case), Lot Number: 2024110190; 3) DYKMBNDL130, UDI-DI: 10193489479027(each), 40193489479028(case), Lot Number: 21ABC197; 4) DYKMBNDL130, UDI-DI: 10193489479027(each), 40193489479028(case), Lot Number: 21ABJ543; 5) DYKMBNDL130, UDI-DI: 10193489479027(each), 40193489479028(case), Lot Number: 21BBB580; 6) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21CLA391; 7) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21CLA391Z; 8) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21CLA621; 9) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21DLA326; 10) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21ELA080; 11) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21FLA214; 12) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21GLA677; 13) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21HLA740; 14) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21ILA163; 15) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21JLA910; 16) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 22ALA593; 17) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 22BLA721; 18) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 22CLA448; 19) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 22DLA407; 20) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 22ELA008; 21) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 22FLA745; 22) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 22GLA694; 23) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 22GLB021; 24) DYKMBNDL4, UDI-DI: 10193489477627(each), 40193489477628(case), Lot Number: 21ALA056; 25) DYKMBNDL4, UDI-DI: 10193489477627(each), 40193489477628(case), Lot Number: 21ALA631; 26) DYKMBNDL4, UDI-DI: 10193489477627(each), 40193489477628(case), Lot Number: 21DLA343; 27) LC295, UDI-DI: 10653160322702(each), 653160322705(case), Lot Number: 2025110490
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0330; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

Devices which did not undergo thermoforming could deform and lose performance.

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

Recall #:
98252
Lot/product code:
Model/Catalog Number: KD-V411M-0330; Material REF: (1) N1089530, (2) N1089510, (3) N5411230; UDI-DI: (1) 04953170380563, (2) 04953170380563, (3) 04953170380563; All Lots with a valid expiration date
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

Medline Convenience Kits: 1) CHEST/BREAST-LF, Model Number: DYNJ83950

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

ALL 50 STATES
▸Full report

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

Recall #:
98329
Lot/product code:
1) DYNJ83950, UDI-DI: 10195327318925(each), 40195327318926(case), Lot Number: 24DBT832; 2) DYNJ83950, UDI-DI: 10195327318925(each), 40195327318926(case), Lot Number: 24CBH626; 3) DYNJ83950, UDI-DI: 10195327318925(each), 40195327318926(case), Lot Number: 23LBR075; 4) DYNJ83950, UDI-DI: 10195327318925(each), 40195327318926(case), Lot Number: 23FBF248; 5) DYNJ83950, UDI-DI: 10195327318925(each), 40195327318926(case), Lot Number: 23CBG610
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

Medline Convenience Kits: 1) MAJOR LAPAROTOMY CDS, Model Number: CDS860015U; 2) MAJOR LAPAROTOMY CDS, Model Number: CDS860015V; 3) MAJOR LAPAROTOMY CDS, Model Number: CDS860015W; 4) MAJOR LAPAROTOMY CDS, Model Number: CDS860015X; 5) MINOR LAPAROTOMY CDS, Model Number: CDS860016P; 6) MINOR LAPAROTOMY CDS, Model Number: CDS860016Q; 7) MINOR LAPAROTOMY CDS, Model Number: CDS860016R; 8) MINOR LAPAROTOMY CDS, Model Number: CDS860016S; 9) LAP GASTRIC BYPASS CDS, Model Number: CDS860146M; 10) NEW LONDON MINOR CDS, Model Number: CDS982518M; 11) NEW LONDON MINOR CDS, Model Number: CDS982518N; 12) NEW LONDON MINOR CDS, Model Number: CDS982518O; 13) NEW LONDON MINOR CDS, Model Number: CDS982518P; 14) GENERAL LAPAROSCOPY CDS, Model Number: CDS983311J; 15) LAVH CDS, Model Number: CDS983411G; 16) NHP ROBOTIC GENERAL CDS, Model Number: CDS984244J; 17) ROBOTIC-LF, Model Number: CDS984543C; 18) CYSTO CDS, Model Number: CDS984592G; 19) CYSTO CDS, Model Number: CDS984592I; 20) ROBOTIC, Model Number: CDS985270F; 21) GENERAL LAPAROSCOPY CDS, Model Number: CDS985422I; 22) ROBOTIC CDS, Model Number: CDS985429L; 23) LAP CHOLE CDS, Model Number: CDS985558N; 24) LAP CHOLE CDS, Model Number: CDS985558O; 25) ENDO KIT, Model Number: DYKE1580A; 26) KIT GEN SURG EXLAP, Model Number: DYKMBNDL105; 27) KIT GEN SURG EXLAP, Model Number: DYKMBNDL105A; 28) KIT GEN SURG EXLAP, Model Number: DYKMBNDL105B; 29) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116; 30) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116B; 31) KIT UROLOGY URETHROPLASTY, Model Number: DYKMBNDL117A; 32) KIT SURG ONC DIAGNOSTIC LAPARO, Model Number: DYKMBNDL12; 33) KIT UROLOGY LAP PHELAN, Model Number: DYKMBNDL121; 34) KIT UROLOGY LAP PHELAN, Model Number: DYKMBNDL121A; 35) KIT UROLOGY LAP PHELAN, Model Number: DYKMBNDL121B; 36) KIT UROLOGY LAP PHELAN, Model Number: DYKMBNDL121C; 37) KIT UROLOGY LAP PHELAN, Model Number: DYKMBNDL121F; 38) KIT L&D CYSTO SETUP, Model Number: DYKMBNDL135A; 39) KIT THORACIC LAPAROSCOPIC HIAT, Model Number: DYKMBNDL136; 40) KIT THORACIC LAPAROSCOPIC HIAT, Model Number: DYKMBNDL136A; 41) KIT THORACIC STAGING LAPAROTOM, Model Number: DYKMBNDL15; 42) KIT SURG ONC LAP DIAG/CV CATH, Model Number: DYKMBNDL153A; 43) KIT SURG ONC LAP DIAG/PORT INS, Model Number: DYKMBNDL153B; 44) KIT LAP DONOR NEPHRECTOMY, Model Number: DYKMBNDL173; 45) KIT LAP DONOR NEPHRECTOMY, Model Number: DYKMBNDL173A; 46) KIT THORACIC HIATAL HERNIA TRA, Model Number: DYKMBNDL175; 47) KIT GEN SURG LAP INGUINAL, Model Number: DYKMBNDL176; 48) KIT GEN SURG LAP INGUINAL, Model Number: DYKMBNDL176A; 49) KIT GEN SURG LAP INGUINAL, Model Number: DYKMBNDL176B; 50) KIT GEN SURG LAP INGUINAL, Model Number: DYKMBNDL176C; 51) KIT THORACIC ROBOTIC LOBECTOMY, Model Number: DYKMBNDL184; 52) KIT THORACIC ROBOTIC LOBECTOMY, Model Number: DYKMBNDL184A; 53) KIT UROLOGY PENILE REPAIR, Model Number: DYKMBNDL188A; 54) KIT UROLOGY LAP SIDDIQUI, Model Number: DYKMBNDL193; 55) KIT UROLOGY LAP SIDDIQUI, Model Number: DYKMBNDL193A; 56) KIT UROLOGY BUCCAL GRAFT, Model Number: DYKMBNDL206; 57) KIT STC PLASTIC FREE FLAP, Model Number: DYKMBNDL54A; 58) KIT UROLOGY CYSTOSCOPY SUPPLEM, Model Number: DYKMBNDL60; 59) KIT UROLOGY CYSTOSCOPY SUPPLEM, Model Number: DYKMBNDL60A; 60) KIT UROLOGY MINOR, Model Number: DYKMBNDL61A; 61) KIT UROLOGY MINOR, Model Number: DYKMBNDL61B; 62) KIT GEN SURG LAP COLECTOMY, Model Number: DYKMBNDL73; 63) KIT GEN SURG LAP COLORECTAL, Model Number: DYKMBNDL73A; 64) KIT GEN SURG LAP COLORECTAL, Model Number: DYKMBNDL73B; 65) KIT GEN SURG LAP COLORECTAL, Model Number: DYKMBNDL73C; 66) KIT GEN SURG LAP COLORECTAL, Model Number: DYKMBNDL73D; 67) KIT GEN SURG LAP GASTRIC BYPAS, Model Number: DYKMBNDL74; 68) KIT GEN SURG LAP GASTRIC BYPAS, Model Number: DYKMBNDL74A; 69) KIT GEN SURG LAP GASTRIC BYPAS, Model Number: DYKMBNDL74B; 70) KIT GEN SURG LAP GASTRIC BYPAS,

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

ALL 50 STATES
▸Full report

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

Recall #:
98329
Lot/product code:
1) CDS860015U, UDI-DI: 10193489847994(each), 40193489847995(case), Lot Number: 21LBT172; 2) CDS860015U, UDI-DI: 10193489847994(each), 40193489847995(case), Lot Number: 21LBD726; 3) CDS860015U, UDI-DI: 10193489847994(each), 40193489847995(case), Lot Number: 21KBB595; 4) CDS860015U, UDI-DI: 10193489847994(each), 40193489847995(case), Lot Number: 21IBL031; 5) CDS860015U, UDI-DI: 10193489847994(each), 40193489847995(case), Lot Number: 21GBS688; 6) CDS860015U, UDI-DI: 10193489847994(each), 40193489847995(case), Lot Number: 21FBR386; 7) CDS860015V, UDI-DI: 10195327209582(each), 40195327209583(case), Lot Number: 22HBF170; 8) CDS860015W, UDI-DI: 10195327349509(each), 40195327349500(case), Lot Number: 23LBQ388; 9) CDS860015W, UDI-DI: 10195327349509(each), 40195327349500(case), Lot Number: 23KBX194; 10) CDS860015W, UDI-DI: 10195327349509(each), 40195327349500(case), Lot Number: 23JBR469; 11) CDS860015W, UDI-DI: 10195327349509(each), 40195327349500(case), Lot Number: 23HBT489; 12) CDS860015W, UDI-DI: 10195327349509(each), 40195327349500(case), Lot Number: 23GBM065; 13) CDS860015W, UDI-DI: 10195327349509(each), 40195327349500(case), Lot Number: 23FBP597; 14) CDS860015X, UDI-DI: 10195327647513(each), 40195327647514(case), Lot Number: 25EBQ940; 15) CDS860015X, UDI-DI: 10195327647513(each), 40195327647514(case), Lot Number: 25DBF532; 16) CDS860015X, UDI-DI: 10195327647513(each), 40195327647514(case), Lot Number: 24EBA340; 17) CDS860015X, UDI-DI: 10195327647513(each), 40195327647514(case), Lot Number: 24DBP400; 18) CDS860015X, UDI-DI: 10195327647513(each), 40195327647514(case), Lot Number: 24DBC504; 19) CDS860016P, UDI-DI: 10193489848007(each), 40193489848008(case), Lot Number: 22FBQ637; 20) CDS860016P, UDI-DI: 10193489848007(each), 40193489848008(case), Lot Number: 22FBH684; 21) CDS860016P, UDI-DI: 10193489848007(each), 40193489848008(case), Lot Number: 22BBL530; 22) CDS860016P, UDI-DI: 10193489848007(each), 40193489848008(case), Lot Number: 22ABD367; 23) CDS860016P, UDI-DI: 10193489848007(each), 40193489848008(case), Lot Number: 21KBI389; 24) CDS860016P, UDI-DI: 10193489848007(each), 40193489848008(case), Lot Number: 21GBV762; 25) CDS860016P, UDI-DI: 10193489848007(each), 40193489848008(case), Lot Number: 21GBV761; 26) CDS860016P, UDI-DI: 10193489848007(each), 40193489848008(case), Lot Number: 21FBC634; 27) CDS860016P, UDI-DI: 10193489848007(each), 40193489848008(case), Lot Number: 21EBD212; 28) CDS860016Q, UDI-DI: 10195327209599(each), 40195327209590(case), Lot Number: 23ABM653; 29) CDS860016Q, UDI-DI: 10195327209599(each), 40195327209590(case), Lot Number: 22KBA835; 30) CDS860016Q, UDI-DI: 10195327209599(each), 40195327209590(case), Lot Number: 22JBE511; 31) CDS860016R, UDI-DI: 10195327349479(each), 40195327349470(case), Lot Number: 24BBK121; 32) CDS860016R, UDI-DI: 10195327349479(each), 40195327349470(case), Lot Number: 23KBP519; 33) CDS860016R, UDI-DI: 10195327349479(each), 40195327349470(case), Lot Number: 23IBO655; 34) CDS860016R, UDI-DI: 10195327349479(each), 40195327349470(case), Lot Number: 23GBD634; 35) CDS860016S, UDI-DI: 10195327647520(each), 40195327647521(case), Lot Number: 25LMH226; 36) CDS860016S, UDI-DI: 10195327647520(each), 40195327647521(case), Lot Number: 25JBA926; 37) CDS860016S, UDI-DI: 10195327647520(each), 40195327647521(case), Lot Number: 25FBG578; 38) CDS860016S, UDI-DI: 10195327647520(each), 40195327647521(case), Lot Number: 25DBK311; 39) CDS860016S, UDI-DI: 10195327647520(each), 40195327647521(case), Lot Number: 24LBS320; 40) CDS860016S, UDI-DI: 10195327647520(each), 40195327647521(case), Lot Number: 24KBA566; 41) CDS860016S, UDI-DI: 10195327647520(each), 40195327647521(case), Lot Number: 24HBG876; 42) CDS860016S, UDI-DI: 10195327647520(each), 40195327647521(case), Lot Number: 24GBQ718; 43) CDS860016S, UDI-DI: 10195327647520(each), 40195327647521(case), Lot Number: 24DBJ711; 44) CDS860016S, UDI-DI: 10195327647520(each), 40195327647521(case), Lot Number: 24CBD741; 45) CDS860146M, UDI-DI: 10195327224547(each), 40195327224548(case), Lot Number: 23ABM631; 46) CDS982518M, UDI-DI: 10193489401028(each), 40193489401029(case), Lot Number: 22EBC713; 47) CDS982518M, UDI-DI: 10193489401028(each), 40193489401029(case), Lot Number: 22BBZ407; 48) CDS982518M, UDI-DI: 10193489401028(each), 40193489401029(case), Lot Number: 21KBE056; 49) CDS982518M, UDI-DI: 10193489401028(each), 40193489401029(case), Lot Number: 21HBH225; 50) CDS982518M, UDI-DI: 10193489401028(each), 40193489401029(case), Lot Number: 21FBI691; 51) CDS982518N, UDI-DI: 10195327144166(each), 40195327144167(case), Lot Number: 22HBS430; 52) CDS982518N, UDI-DI: 10195327144166(each), 40195327144167(case), Lot Number: 22HBA456; 53) CDS982518O, UDI-DI: 10195327247386(each), 40195327247387(case), Lot Number: 23ABD137; 54) CDS982518O, UDI-DI: 10195327247386(each), 40195327247387(case), Lot Number: 22LBC678; 55) CDS982518P, UDI-DI: 10195327318857(each), 40195327318858(case), Lot Number: 24BBO559; 56) CDS982518P, UDI-DI: 10195327318857(each), 4019532731885… (truncated, 138514 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 January 7, 2026

Medline Convenience Kits: 1) OR ARTERIOGRAM, Model Number: CDS985094F; 2) KIT SURG ONC LAP DIAG/CV CATH, Model Number: DYKMBNDL153; 3) KIT ACES INSERT PERCUTANEOUS T, Model Number: DYKMBNDL4A; 4) KIT ACES INSERT PERCUTANEOUS T, Model Number: DYKMBNDL4B; 5) VEIN PROCEDURE KIT, Model Number: DYNDA2076C; 6) CARDIAC CATH PACK-LF, Model Number: DYNJ0150605AC; 7) CATH LAB PACK-LF, Model Number: DYNJ0648473Y; 8) NBMC CATH PACK-LF, Model Number: DYNJ0803367I; 9) ANGIO PACK-LF, Model Number: DYNJ0954970I; 10) CARDIAC CATH PACK, Model Number: DYNJ19946M; 11) CATH LAB PACK, Model Number: DYNJ30955I; 12) CATH LAB PACK, Model Number: DYNJ31773K; 13) CATH PACK-LF, Model Number: DYNJ33061D; 14) DB CCL OAKWOOD PACK-LF, Model Number: DYNJ33620D; 15) CARDIAC CATH PACK MRH-LF, Model Number: DYNJ35300M; 16) CATH LAB PK, Model Number: DYNJ35643C; 17) CARDIAC CATH PACK-LF, Model Number: DYNJ39066B; 18) CATH PACK-LF, Model Number: DYNJ43101C; 19) OR ANGIO PACK-LF, Model Number: DYNJ43415D; 20) OR ANGIO PACK-LF, Model Number: DYNJ43415F; 21) ANGIOPLASTY PACK, Model Number: DYNJ44700J; 22) ANGIOGRAPHY DRAPE PACK, Model Number: DYNJ44850J; 23) RADIOLOGICAL PACK, Model Number: DYNJ44889O; 24) CARDIAC CATH PACK, Model Number: DYNJ47370B; 25) ANGIOGRAPHY PACK, Model Number: DYNJ53129D; 26) ANGIOGRAPHY DRAPE PACK, Model Number: DYNJ56772G; 27) DR. MOHINDRA PACK, Model Number: DYNJ57602G; 28) NE ENDO VASCULAR PACK, Model Number: DYNJ57940B; 29) CARDIAC CATH PACK - Q1, Model Number: DYNJ58048C; 30) OR ANGIO, Model Number: DYNJ59931B; 31) LPCH PERRY CATH PACK, Model Number: DYNJ67378C; 32) HOSPITAL REGIONAL DE CONCEPCIO, Model Number: DYNJ67918A; 33) CATH LAB PACK, Model Number: DYNJ68633; 34) STEWARD CATH LAB PACK GSS, Model Number: DYNJ81197B; 35) STEWARD CATH LAB PACK GSS, Model Number: DYNJ81197C; 36) STEWARD CATH LAB PACK GSS, Model Number: DYNJ81197D; 37) STEWARD CATH LAB PACK GSS, Model Number: DYNJ81197F; 38) STEWARD CATH LAB PACK GSS, Model Number: DYNJ81197G; 39) BASIC CARDIAC CATH PACK, Model Number: DYNJ81593B; 40) UMC EL PASO CATH PACK, Model Number: DYNJ83089; 41) DR. MOHINDRA PACK, Model Number: DYNJ83819A; 42) VZ VAS/ANG PACK, Model Number: DYNJ83981; 43) WCPN CARDIOLOGY PACK, Model Number: DYNJ84539; 44) CATH LAB, Model Number: DYNJ85511; 45) ANGIOGRAPHY DRAPE PACK, Model Number: DYNJT1520K; 46) ANGIOGRAPHY TRAY, Model Number: MNS9130; 47) CVC BUNDLE KIT, Model Number: ECVC6225A; 48) CVC 3L 7F 20CM VANTEX, Model Number: ECVC7265A

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

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

Recall #:
98329
Lot/product code:
1) CDS985094F, UDI-DI: 10195327657642(each), 40195327657643(case), Lot Number: 25AMG933; 2) DYKMBNDL153, UDI-DI: 10193489478440(each), 40193489478441(case), Lot Number: 22ABO093; 3) DYKMBNDL153, UDI-DI: 10193489478440(each), 40193489478441(case), Lot Number: 21LBJ748; 4) DYKMBNDL153, UDI-DI: 10193489478440(each), 40193489478441(case), Lot Number: 21BBG516; 5) DYKMBNDL153, UDI-DI: 10193489478440(each), 40193489478441(case), Lot Number: 21ABI976; 6) DYKMBNDL4A, UDI-DI: 10193489904512(each), 40193489904513(case), Lot Number: 22ALA279; 7) DYKMBNDL4A, UDI-DI: 10193489904512(each), 40193489904513(case), Lot Number: 21KLA100; 8) DYKMBNDL4A, UDI-DI: 10193489904512(each), 40193489904513(case), Lot Number: 21GLA930; 9) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 25ALA014; 10) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 24FLA816; 11) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 24CLA777; 12) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 23KLA402; 13) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 23JLA979; 14) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 23ILA268; 15) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 23HLA316; 16) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 23GLA710; 17) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 23GLA176; 18) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 23BLA583; 19) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 22HLB260; 20) DYNDA2076C, UDI-DI: 10198459001208(each), 40198459001209(case), Lot Number: 24LMB205; 21) DYNDA2076C, UDI-DI: 10198459001208(each), 40198459001209(case), Lot Number: 24KMC111; 22) DYNDA2076C, UDI-DI: 10198459001208(each), 40198459001209(case), Lot Number: 24HMD928; 23) DYNJ0150605AC, UDI-DI: 10198459106422(each), 40198459106423(case), Lot Number: 24IMB736; 24) DYNJ0648473Y, UDI-DI: 10195327647834(each), 40195327647835(case), Lot Number: 25EBR586; 25) DYNJ0648473Y, UDI-DI: 10195327647834(each), 40195327647835(case), Lot Number: 25CBO084; 26) DYNJ0648473Y, UDI-DI: 10195327647834(each), 40195327647835(case), Lot Number: 25BBT175; 27) DYNJ0648473Y, UDI-DI: 10195327647834(each), 40195327647835(case), Lot Number: 25ABH209; 28) DYNJ0648473Y, UDI-DI: 10195327647834(each), 40195327647835(case), Lot Number: 24LBE715; 29) DYNJ0648473Y, UDI-DI: 10195327647834(each), 40195327647835(case), Lot Number: 24IBS786; 30) DYNJ0648473Y, UDI-DI: 10195327647834(each), 40195327647835(case), Lot Number: 24HBQ060; 31) DYNJ0648473Y, UDI-DI: 10195327647834(each), 40195327647835(case), Lot Number: 24GBT979; 32) DYNJ0803367I, UDI-DI: 10195327461027(each), 40195327461028(case), Lot Number: 23IMC122; 33) DYNJ0954970I, UDI-DI: 10198459297571(each), 40198459297572(case), Lot Number: 25FMJ515; 34) DYNJ19946M, UDI-DI: 10193489907933(each), 40193489907934(case), Lot Number: 23HBO857; 35) DYNJ30955I, UDI-DI: 10195327428051(each), 40195327428052(case), Lot Number: 23GBN513; 36) DYNJ31773K, UDI-DI: 10195327245856(each), 40195327245857(case), Lot Number: 23ABB938; 37) DYNJ33061D, UDI-DI: 10193489841428(each), 40193489841429(case), Lot Number: 21CBI315; 38) DYNJ33620D, UDI-DI: 10889942677832(each), 40889942677833(case), Lot Number: 21ADA464; 39) DYNJ35300M, UDI-DI: 10195327101169(each), 40195327101160(case), Lot Number: 22JMB302; 40) DYNJ35643C, UDI-DI: 10195327111946(each), 40195327111947(case), Lot Number: 23CBI301; 41) DYNJ39066B, UDI-DI: 10193489937268(each), 40193489937269(case), Lot Number: 23HMG433; 42) DYNJ43101C, UDI-DI: 10888277737327(each), 40888277737328(case), Lot Number: 21ADA535; 43) DYNJ43415D, UDI-DI: 10195327512873(each), 40195327512874(case), Lot Number: 24CBG256; 44) DYNJ43415D, UDI-DI: 10195327512873(each), 40195327512874(case), Lot Number: 24ABI910; 45) DYNJ43415D, UDI-DI: 10195327512873(each), 40195327512874(case), Lot Number: 23IBP533; 46) DYNJ43415F, UDI-DI: 10195327674731(each), 40195327674732(case), Lot Number: 25EBF775; 47) DYNJ43415F, UDI-DI: 10195327674731(each), 40195327674732(case), Lot Number: 24LBQ306; 48) DYNJ43415F, UDI-DI: 10195327674731(each), 40195327674732(case), Lot Number: 24KBR090; 49) DYNJ43415F, UDI-DI: 10195327674731(each), 40195327674732(case), Lot Number: 24IBU874; 50) DYNJ43415F, UDI-DI: 10195327674731(each), 40195327674732(case), Lot Number: 24HBM254; 51) DYNJ43415F, UDI-DI: 10195327674731(each), 40195327674732(case), Lot Number: 24GBV382; 52) DYNJ44700J, UDI-DI: 10195327277413(each), 40195327277414(case), Lot Number: 25JDA679; 53) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 23IBB504; 54) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 23GBP204; 55) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 23FBF258; 56) DYNJ44850J, UDI-DI: 10193489… (truncated, 15372 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 January 7, 2026

Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0725; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

Devices which did not undergo thermoforming could deform and lose performance.

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

Recall #:
98252
Lot/product code:
Model/Catalog Number: KD-VC411Q-0725; Material REF: N5424710; UDI-DI: N/A; All Lots with a valid expiration date
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 6, 2026

PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without Sealed Dialysate System

There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

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

Recall #:
98180
Lot/product code:
UDI/DI 07332414090005, All lots including and manufactured after 24F0100CA
Recalling firm:
VANTIVE US HEALTHCARE LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 6, 2026

PRISMAFLEX ST150 SET US, Product Code 107640US; Dialyzer, High Permeability With Or Without Sealed Dialysate System

There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

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

Recall #:
98180
Lot/product code:
UDI/DI 00085412917696, All lots including and manufactured after 24F0085
Recalling firm:
VANTIVE US HEALTHCARE LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled January 6, 2026

AQ 120 GFEW, Aquarion Preserved Cartridges (2) 3.7 Gallons each

CGMP deviations.

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

Recall #:
D-0260-2026
Lot/product code:
Lot #: 239066, Exp. Date 1/24/2027; 378106, Exp. Date 3/8/2026; 379202, Exp. Date 3/29/2026; 379750, Exp. Date 4/24/2026; 380983, Exp. Date 5/24/2026; 382901, Exp. Date 7/11/2026; 384682, Exp. Date 8/16/2026; 386189, Exp. Date 9/20/2026; 387559, Exp. Date 10/11/2026; 388381, Exp. Date 11/2/2026; 398066, Exp. Date 1/24/2027; 389477, Exp. Date 2/21/2027; 392491, Exp. Date 3/13/2027; 393724, Exp. Date 4/3/2027, 394683, Exp. Date 4/29/2027; 395094, Exp. Date 5/29/2027; 395231, Exp. Date 6/18/2027; 395368, Exp. Date 7/17/2027, 397971, Exp. Date 11/8/2027; 398930, Exp. Date 8/28/2027; 399204, Exp. Date 9/25/2027; 400300, Exp. Date 10/16/2027; 403177, Exp. Date 11/8/2027; 403314, Exp. Date 11/25/2027; 405095, Exp. Date 1/24/2028; 406328, Exp. Date 2/14/2028; 407700, Exp. Date 4/3/2028; 407974, Exp. Date 4/17/2028; ; 410166, Exp. Date 6/13/2028; 410988, Exp. Date 7/1/2028.
Recalling firm:
Encon Safety Products Co
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 6, 2026

PRISMAFLEX TPE2000 SET, Product Code 114093; Dialyzer, High Permeability With Or Without Sealed Dialysate System

There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

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

Recall #:
98180
Lot/product code:
UDI/DI 07332414111038, All lots including and manufactured after 24J0106
Recalling firm:
VANTIVE US HEALTHCARE LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 6, 2026

PRISMAFLEX HF1000 SET, Product Code 107142; Dialyzer, High Permeability With Or Without Sealed Dialysate System

There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

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▸Full report

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

Recall #:
98180
Lot/product code:
UDI/DI 07332414069315, All lots including and manufactured after 24F0094CA
Recalling firm:
VANTIVE US HEALTHCARE LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 6, 2026

OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without Sealed Dialysate System

There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

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

Recall #:
98180
Lot/product code:
UDI/DI 07332414102234, All lots including and manufactured after 24G0041Z
Recalling firm:
VANTIVE US HEALTHCARE LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 6, 2026

PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialysate System

There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

ALL 50 STATES
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FDA has not published a risk classification for this recall yet.

Recall #:
98180
Lot/product code:
UDI/DI 07332414069254, All lots including and manufactured after 24G0034CA
Recalling firm:
VANTIVE US HEALTHCARE LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 6, 2026

PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System

There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

ALL 50 STATES
▸Full report

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

Recall #:
98180
Lot/product code:
UDI/DI 07332414064556, All lots including and manufactured after 24F0077CA
Recalling firm:
VANTIVE US HEALTHCARE LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 6, 2026

PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or Without Sealed Dialysate System

There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

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

Recall #:
98180
Lot/product code:
UDI/DI 00085412954073, All lots including and manufactured after 24G0072
Recalling firm:
VANTIVE US HEALTHCARE LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 6, 2026

WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM

The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown.

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

Recall #:
98265
Lot/product code:
Article Number: 065.4810; UDI-DI: 07630031741110; Lot numbers: VWPX4, VWPX6;
Recalling firm:
Straumann USA LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 5, 2026

Medline Convenience Kits: 1) NAIL KIT, Model Number: DYKM1528

Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.

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

Recall #:
98319
Lot/product code:
1) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 25BBO366; 2) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 25ABI804; 3) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 25ABF375; 4) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 24JBL155; 5) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 24IBG900; 6) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 24FBT801; 7) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 24FBC584; 8) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 24DBB692; 9) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 24BBL239; 10) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 23KBO692; 11) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 23IBT788; 12) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 23HBJ026; 13) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 23EBK780; 14) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 23DBL149; 15) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 23CBJ576 Additional Lot as of 3/27/26: 1) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 25IBP134
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 5, 2026

Raz-AT (Attendant Tilt) Mobile Shower Commode Chair, Catalog Number Z300 UDI-DI code: (01)00628758003007 Raz-ART (Attendant Rotational Tilt) Mobile Shower Commode Chair, Catalog Number Z333 UDI-DI code: (01)00628758003335 Raz-AT600 (Bariatric Tilt) Mobile Shower Commode Chair, Catalog Number Z360 UDI-DI code: (01)00628758003601 Raz-SP (Self Propel) Mobile Shower Commode Chair, Catalog Number Z200 UDI-DI code: (01)00628758001003 Raz-AP (Attendant Propel) Mobile Shower Commode Chair, Catalog Number Z100 UDI-DI code: (01)00628758001003 The Raz Mobile Shower Commode Chair is intended to be used by people with mobility impairments, who may have difficulty in standing or keeping their balance while completing activities such as showering, toileting, or personal hygiene.

Due to a modification by a vendor and may be reinstalled without properly engaging the outside rear seat brackets that are used to keep the seat in place.

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

Recall #:
98254
Lot/product code:
Raz-AT (Attendant Tilt) Mobile Shower Commode Chair Catalog Number Z300 Seat Catalog Numbers: ZVFIFAR17 ZVFIFAR20 ZCSEAT (FAR) UDI-DI code: (01)00628758003007 Serial Numbers: RAT218789 RAT116906 RAT200337 RAT208010 RAT208987 RAT210426 RAT211344 RAT211837 RAT211998 RAT212001 RAT212066 RAT212450 RAT213190 RAT213227 RAT214334 RAT217987 RAT218213 RAT218552 RAT218570 RAT218612 RAT219142 RAT220066 RAT222210 RAT223140 RAT224902 RAT206923 RAT217768 RAT221724 RAT213036 RAT218862 RAT221044 RAT216437 RAT217073 RAT218555 RAT218557 RAT219817 RAT121348 RAT216055 RAT217379 RAT220648 RAT124264 RAT200864 Raz-ART (Attendant Rotational Tilt) Mobile Shower Commode Chair Catalog Number Z333 Seat Catalog Numbers: ZVFIFAR17 ZVFIFAR20 ZCSEAT (FAR) UDI-DI code: (01)00628758003335 Serial Numbers: ART219556 ART222544 ART211605 ART223825 ART212722 ART212675 Raz-AT600 (Bariatric Tilt) Mobile Shower Commode Chair Catalog Number Z360 Seat Catalog Numbers: ZCSEATHD (FAR) UDI-DI code: (01)00628758003601 Serial Numbers: BAT216618 BAT204112 Raz-SP (Self Propel) Mobile Shower Commode Chair Catalog Number Z200 Seat Catalog Numbers: ZVFIFAR17 ZVFIFAR20 ZCSEAT (FAR) UDI-DI code: (01)00628758001003 Serial Numbers: RAS210872 RAS214903 RAS217818 RAS220760 RAS209166 RAS218239 RAS107030 RAS214470 Raz-AP (Attendant Propel) Mobile Shower Commode Chair Catalog Number Z100 Seat Catalog Numbers: ZVFIFAR17 ZVFIFAR 20 ZCSEAT (FAR) UDI-DI code: (01)00628758001003 Serial Numbers: RAS217210 RAS224711 RAS214364 FAR Seat (Demo) Catalog Numbers: ZVFI17FAR-A ZCSEAT-A UDI-DI code: N/A Serial Numbers: N/A
Recalling firm:
Raz Design Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 5, 2026

Medline Convenience Kits: 1) TRUNK KIT W/EXPIRATION, Model Number: DYKM1361A; 2) TRUNK KIT 1EA, Model Number: DYKM2013; 3) TRUNK KIT 1EA, Model Number: DYKM2013A; 4) RN TRUNK KIT, Model Number: DYKM2699; 5) TRUNK KIT, Model Number: DYKTRUNK1

Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.

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

Recall #:
98319
Lot/product code:
1) DYKM1361A, UDI-DI: 10193489586862(each), 40193489586863(case), Lot Number: 25JBG340; 2) DYKM1361A, UDI-DI: 10193489586862(each), 40193489586863(case), Lot Number: 25EBV829; 3) DYKM1361A, UDI-DI: 10193489586862(each), 40193489586863(case), Lot Number: 25CBM029; 4) DYKM1361A, UDI-DI: 10193489586862(each), 40193489586863(case), Lot Number: 25BBI797; 5) DYKM1361A, UDI-DI: 10193489586862(each), 40193489586863(case), Lot Number: 25ABW687; 6) DYKM2013, UDI-DI: 10193489796582(each), 40193489796583(case), Lot Number: 23EBN045; 7) DYKM2013, UDI-DI: 10193489796582(each), 40193489796583(case), Lot Number: 23DBM064; 8) DYKM2013A, UDI-DI: 10195327419868(each), 40195327419869(case), Lot Number: 25HBB845; 9) DYKM2013A, UDI-DI: 10195327419868(each), 40195327419869(case), Lot Number: 25GBS259; 10) DYKM2013A, UDI-DI: 10195327419868(each), 40195327419869(case), Lot Number: 25DBR145; 11) DYKM2013A, UDI-DI: 10195327419868(each), 40195327419869(case), Lot Number: 25BBS769; 12) DYKM2013A, UDI-DI: 10195327419868(each), 40195327419869(case), Lot Number: 24KBJ466; 13) DYKM2013A, UDI-DI: 10195327419868(each), 40195327419869(case), Lot Number: 24JBQ815; 14) DYKM2013A, UDI-DI: 10195327419868(each), 40195327419869(case), Lot Number: 24IBU526; 15) DYKM2013A, UDI-DI: 10195327419868(each), 40195327419869(case), Lot Number: 23IBJ540; 16) DYKM2013A, UDI-DI: 10195327419868(each), 40195327419869(case), Lot Number: 23HBP844; 17) DYKM2013A, UDI-DI: 10195327419868(each), 40195327419869(case), Lot Number: 23HBE308; 18) DYKM2013A, UDI-DI: 10195327419868(each), 40195327419869(case), Lot Number: 23GBT102; 19) DYKM2699, UDI-DI: 10195327610654(each), 40195327610655(case), Lot Number: 25DLA344; 20) DYKM2699, UDI-DI: 10195327610654(each), 40195327610655(case), Lot Number: 25CLA657; 21) DYKM2699, UDI-DI: 10195327610654(each), 40195327610655(case), Lot Number: 24GLB208; 22) DYKM2699, UDI-DI: 10195327610654(each), 40195327610655(case), Lot Number: 24ELA332; 23) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 25HBS451; 24) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 25HBS450; 25) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 25HBE908; 26) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 25HBE909; 27) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 25GBM037; 28) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 25GBK565; 29) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 25FBL177; 30) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 25EBP727; 31) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 25EBO749; 32) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 25DBQ021; 33) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 25DBD942; 34) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 25DBA345; 35) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 25BBU730; 36) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 25BBS503; 37) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 25ABM247; 38) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 24KBN725; 39) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 24KBE264; 40) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 24IBH956; 41) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 24IBH955; 42) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 24IBH957; 43) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 24HBQ854; 44) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 24HBO200; 45) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 24GBN624; 46) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 24FBH929; 47) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 24FBG790; 48) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 24FBD096; 49) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 24DBS507; 50) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 24DBC075; 51) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 24CBG460; 52) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 24ABO402; 53) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 23LBU172; 54) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 23KBK857; 55) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 23KBJ794; 56) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 23JBM608; 57) DYKTRUNK1, UDI-DI: 10888277… (truncated, 5983 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 January 5, 2026

Medline Sterile Saline Wound Wash, Cleansing & Wound Irrigation, USP Normal Saline (0.9% Sodium Chloride), 7.1 FL OZ (210 mL), DBD-CAN,SPRAY,7.1-OZ,SALINE,WOUND WASH,S, Model Number MDSALINE7

Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.

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

Recall #:
98319
Lot/product code:
MDSALINE7 - UDI-DI: 10193489089356 (each), 20193489089353 (case), All Lots
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 5, 2026

Meijer STERILE saline wound wash, First Aid Cleansing Spray, 0.9% USP SODIUM CHLORIDE, 7.1FL OZ (210 mL), DBD-CAN,SPRAY,7.1-OZ,SALINE,WOUND WASH,S, Model Number MJSALINE7

Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.

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

Recall #:
98319
Lot/product code:
Model Number MJSALINE7 - UDI-DI: 00708820657052 (unit), 10708820657059 (case), All Lots
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 5, 2026

Medline Convenience Kits: 1) NAIL KIT, Model Number: POD14214

Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.

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

Recall #:
98319
Lot/product code:
1) POD14214, UDI-DI: 10889942819362(each), 40889942819363(case), Lot Number: 25CBS147; 2) POD14214, UDI-DI: 10889942819362(each), 40889942819363(case), Lot Number: 25CBJ329; 3) POD14214, UDI-DI: 10889942819362(each), 40889942819363(case), Lot Number: 25ABU209; 4) POD14214, UDI-DI: 10889942819362(each), 40889942819363(case), Lot Number: 24DBJ364; 5) POD14214, UDI-DI: 10889942819362(each), 40889942819363(case), Lot Number: 24DBB718; 6) POD14214, UDI-DI: 10889942819362(each), 40889942819363(case), Lot Number: 23JBV524; 7) POD14214, UDI-DI: 10889942819362(each), 40889942819363(case), Lot Number: 23IBU998; 8) POD14214, UDI-DI: 10889942819362(each), 40889942819363(case), Lot Number: 23IBF119
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 5, 2026

VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem/Vaborbactam (mev01n) o Imipenem (ipm05n) o Imipenem/Relebactam (ipr01n); CARD NAME/ PRODUCT REFERENCE: AST-N399 423701 AST-N402 423644 AST-N403 423645 AST-N404 423664 AST-N405 423864 AST-N406 423869 AST-N407 423870 AST-N409 423925 AST-N412 423936 AST-N413 423928 AST-N414 423933 AST-N415 423934 AST-N416 423935 AST-N417 423880 AST-N419 423948 AST-N421 424055 AST-N428 424320 AST-N429 424321 AST-N430 424322 AST-N433 424389 AST-N439 424501 AST-N440 424502 AST-N443 424541 AST-N444 424587 AST-N467 424857 AST-N476 424934 AST-N478 425052 AST-N480 425084 AST-N481 425085 AST-N485 425182 AST-N496 425265 AST-N800 423310 AST-N802 423706 AST-N804 424634 AST-N808 424711 AST-N810 424712 AST-N811 424713 AST-N813 424722 AST-N815 425054 AST-XN09 423425 AST-XN15 423829 AST-XN17 423673 AST-XN18 423874 AST-XN20 423947 AST-XN21 424197 AST-XN22 424199 AST-XN23 424198 AST-XN24 424351 AST-XN26 424500 AST-XN28 424586 AST-XN29 424604 AST-XN30 424639 AST-XN31 424640 AST-XN32 424678 AST-XN33 424723 AST-XN34 424752 AST-XN35 424810 AST-XN36 424860 AST-XN37 424888 AST-XN38 425074 AST-XN39 425086 AST-XN40 425095 AST-XN41 425204 AST-XN42 425309 ***Update 4/2/26 -- Additional product references not manufactured at time of initial notification. These products will not be distributed within the United States.*** AST-N484 Ref. 425181 AST-N486 Ref. 425183 AST-N491 Ref. 425206 AST-N494 Ref. 425224 AST-N485 Ref. 425182 AST-XN41 Ref. 425204 AST-XN42 Ref. 425309 AST-N504 Ref. 425491

Potential risk of Quality Control failures and/or false resistant antibiotic results when testing isolates of Enterobacterales/Enterobacteriaceae species and/or Pseudomonas aeruginosa with the identified antibiotic formulations. Issue may lead to QC failure or false resistant results.

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

Recall #:
98268
Lot/product code:
All lot codes of the identified Gram-negative AST test kits.
Recalling firm:
Biomerieux Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 2, 2026

Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01.

Tyvek bag seal issue which may compromise sterility of the kit.

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

Recall #:
98298
Lot/product code:
Kit Code: LIFE0080-01. UDI-DI: 10809160314500. Lot Number: 1650056. Expiration Date: 07/24/2028
Recalling firm:
AVID Medical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 2, 2026

ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 267-01-000-10-N UDI-DI code: 00190376541471; GMDN 12844 The ATEC Navigation Disc Prep Instruments are intended for use in surgical procedures. These instruments are non-sterile or sterile packaged, re-usable or single-use instruments designed to function with the Medtronic StealthStation System and NavLock Tracker.

Due a design issue where the navigated array connection geometry is incorrect.

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

Recall #:
98251
Lot/product code:
Model/Catalog Number: 267-01-000-10-N UDI-DI code: 00190376541471 Lot Number: EM56693
Recalling firm:
Alphatec Spine, Inc.
View official FDA record (opens in a new tab)