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Recalls affecting Maryland

Data last updated: September 8, 2026 at 1:13 PM UTC

16,826 recalls found

Just announced

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

Business Pill, Branch Manager for 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/virusAnnounced September 4, 2026

Foods Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

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

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

B. 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

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

Great Value — Organic Triple Berry Blend

Possible E. Coli Contamination

▸Full report
Food & BeveragesFoodborne Illness

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

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

Company contact: Info.foodsafety@comfrut.com

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

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

Presence of particulate matter and lack of sterility assurance

▸Full report
Food & Beverages

Recalling firm: American Regent, Inc.

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

View FDA’s announcement (opens in a new tab)
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

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

Everything Sprouts — Robust Radish Mix, 5oz Cups

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

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

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

Company contact: everythingsproutsmn@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusAnnounced 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)
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UnclassifiedRisk not yet known
Medical deviceRecalled May 4, 2026

MEDLINE Medical Procedure Kits labeled as: 1) BASIC HEART PACK, Medline Kit/SKU DYNJ67331B; 2) CARDIAC SURGERY, Medline Kit/SKU DYNJ911589A; 3) CAROTID ENDARTECOMY, Medline Kit/SKU DYNJ36211D; 4) CHLA ECMO / CARDIAC PACK, Medline Kit/SKU DYNJ87973; 5) CHLA ECMO / CARDIAC PACK, Medline Kit/SKU DYNJ87973A; 6) CV PART 1 AND 2, Medline Kit/SKU DYNJ908879; 7) CV PART 1 AND 2, Medline Kit/SKU DYNJ908879C; 8) FEM POP CDS, Medline Kit/SKU CDS983670K; 9) LAP BASIN TRAY, Medline Kit/SKU DYNJ50908B; 10) OPEN HEART LTX CATHETERS KIT, Medline Kit/SKU DYNJ0049032A; 11) OPEN HEART PACK, Medline Kit/SKU DYNJ80549C; 12) OPEN HEART PACK, Medline Kit/SKU DYNJ80549D; 13) RR-ADULT ECMO PACK, Medline Kit/SKU DYNJ69742B; 14) TAVR, Medline Kit/SKU DYNJ906509C.

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

ALL 50 STATES
▸Full report

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

Recall #:
98994
Lot/product code:
Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case), Lot Number 23JBM539; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case), Lot Number 23IBF088; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case), Lot Number 23FBM203; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case), Lot Number 22JBK233; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case), Lot Number 22JBB115; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case), Lot Number 22IBO304; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case), Lot Number 22HBR331; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case), Lot Number 22FBM460; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case), Lot Number 22DBS093; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case), Lot Number 22CBJ072; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case), Lot Number 22BBX288; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case), Lot Number 21LBU240; Medline Kit Number/SKU DYNJ67331B: UDI/DI 10195327013837 (each), 40195327013838 (case), Lot Number 21JBP452; Medline Kit Number/SKU DYNJ911589A: UDI/DI 10198459646102 (each), 40198459646103 (case), Lot Number 26CBD487; Medline Kit Number/SKU DYNJ36211D: UDI/DI 10889942885657 (each), 40889942885658 (case), Lot Number 24EBB811; Medline Kit Number/SKU DYNJ36211D: UDI/DI 10889942885657 (each), 40889942885658 (case), Lot Number 24ABV035; Medline Kit Number/SKU DYNJ36211D: UDI/DI 10889942885657 (each), 40889942885658 (case), Lot Number 23LBG394; Medline Kit Number/SKU DYNJ36211D: UDI/DI 10889942885657 (each), 40889942885658 (case), Lot Number 23KBA664; Medline Kit Number/SKU DYNJ36211D: UDI/DI 10889942885657 (each), 40889942885658 (case), Lot Number 23HBC987; Medline Kit Number/SKU DYNJ36211D: UDI/DI 10889942885657 (each), 40889942885658 (case), Lot Number 23GBQ638; Medline Kit Number/SKU DYNJ36211D: UDI/DI 10889942885657 (each), 40889942885658 (case), Lot Number 23EBM118; Medline Kit Number/SKU DYNJ36211D: UDI/DI 10889942885657 (each), 40889942885658 (case), Lot Number 23DBB008; Medline Kit Number/SKU DYNJ36211D: UDI/DI 10889942885657 (each), 40889942885658 (case), Lot Number 22KBR412; Medline Kit Number/SKU DYNJ87973: UDI/DI 10198459085031 (each), 40198459085032 (case), Lot Number 24HMH646; Medline Kit Number/SKU DYNJ87973A: UDI/DI 10198459159633 (each), 40198459159634 (case), Lot Number 24JMG070; Medline Kit Number/SKU DYNJ908879: UDI/DI 10195327203429 (each), 40195327203420 (case), Lot Number 22HBX489; Medline Kit Number/SKU DYNJ908879C: UDI/DI 10195327690885 (each), 40195327690886 (case), Lot Number 24KBD462; Medline Kit Number/SKU DYNJ908879C: UDI/DI 10195327690885 (each), 40195327690886 (case), Lot Number 24IBQ955; Medline Kit Number/SKU DYNJ908879C: UDI/DI 10195327690885 (each), 40195327690886 (case), Lot Number 24GBA028; Medline Kit Number/SKU DYNJ908879C: UDI/DI 10195327690885 (each), 40195327690886 (case), Lot Number 24FBI615; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case), Lot Number 26BBJ555; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case), Lot Number 26BBB853; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case), Lot Number 25LBA306; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case), Lot Number 25IBD419; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case), Lot Number 25HBM069; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case), Lot Number 25GBT806; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case), Lot Number 25GBB405; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case), Lot Number 25DBE889; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case), Lot Number 25CBT575; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case), Lot Number 25ABT789; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case), Lot Number 25ABJ907; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case), Lot Number 24LBI235; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case), Lot Number 24KBQ247; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case), Lot Number 24JBT379; Medline Kit Number/SKU CDS983670K: UDI/DI 10193489952568 (each), 40193489952569 (case), Lot Number 24IBT329; M… (truncated, 9891 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)
Class IIILow risk
DrugRecalled May 4, 2026

Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195, Made in Canada, NDC 25021-241-10.

Failed Impurities/Degradation Specifications

ALL 50 STATES
▸Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0539-2026
Lot/product code:
Lot #: 656412, Exp. Date 08/31/2026; 659646, Exp. Date 03/31/2027.
Recalling firm:
Sagent Pharmaceuticals
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 4, 2026

MEDLINE Medical Procedure Kits labeled as: 1) BNT CV PACK, Medline Kit Number/SKU DYNJ912271; 2) CV PACK PART 1, Medline Kit Number/SKU DYNJ31204D; 3) KIT PERIPHERAL VASCULAR MMC, Medline Kit Number/SKU DYNJ905368D; 4) KIT PERIVASCULAR MMC, Medline Kit Number/SKU DYNJ905368B; 5) VP SHUNT PACK, Medline Kit Number/SKU DYNJ46530I.

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

ALL 50 STATES
▸Full report

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

Recall #:
98994
Lot/product code:
Medline Kit Number/SKU DYNJ912271: UDI/DI 10198459688324 (each), 40198459688325 (case), Lot Number 26CBQ109; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 25FBO720; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 24KBO387; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 24KBO015; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 24KBD819; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 24KBA736; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 24FBG144; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 24DBO838; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 24BBC453; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 24ABM118; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 23KBS950; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 23IBC670; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 22LBN883; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 22KBF121; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 22IBN293; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 22FBO695; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 22OBH349; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 21JBY498; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 21JBY507; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 21JBH105; Medline Kit Number/SKU DYNJ905368D: UDI/DI 10198459698149 (each), 40198459698140 (case), Lot Number 26DBE022; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 25GBD045; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 25EBN367; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 25CBR397; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 25BBK435; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 25ABR151; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 24JBU152; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 24IBD106; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 24HBI890; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 24GBS879; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 24EBB182; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 24CBT638; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 24CBN624; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 23KBU577; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 23IBS119; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 23GBV028; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 23HBO351; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 23BBL739; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 23BBL740; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 23ABS355; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 23ABG430; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 22GBG375; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 22GBG376; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 22GBG377; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lo… (truncated, 5797 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 May 4, 2026

MEDLINE Medical Procedure Kits labeled as: 1) KIT UROLOGY URETHROPLASTY, Medline Kit Number/SKU DYKMBNDL117C; 2) URETHROPLASTY, Medline Kit Number/SKU DYNJ908978; 3) URETHROPLASTY, Medline Kit Number/SKU DYNJ908978F.

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

ALL 50 STATES
▸Full report

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

Recall #:
98994
Lot/product code:
Medline Kit Number/SKU DYKMBNDL117C: UDI/DI 10195327371104 (each), 40195327371105 (case), Lot Number 23DLA834; Medline Kit Number/SKU DYNJ908978: UDI/DI 10195327231132 (each), 40195327231133 (case), Lot Number 23BMC463; Medline Kit Number/SKU DYNJ908978: UDI/DI 10195327231132 (each), 40195327231133 (case), Lot Number 23AMA685; Medline Kit Number/SKU DYNJ908978: UDI/DI 10195327231132 (each), 40195327231133 (case), Lot Number 23AMB905; Medline Kit Number/SKU DYNJ908978: UDI/DI 10195327231132 (each), 40195327231133 (case), Lot Number 22LMG466; Medline Kit Number/SKU DYNJ908978: UDI/DI 10195327231132 (each), 40195327231133 (case), Lot Number 22LMB983; Medline Kit Number/SKU DYNJ908978F: UDI/DI 10198459228803 (each), 40198459228804 (case), Lot Number 25JBD225; Medline Kit Number/SKU DYNJ908978F: UDI/DI 10198459228803 (each), 40198459228804 (case), Lot Number 25HBW236.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 4, 2026

MEDLINE Medical Procedure Kits labeled as: 1) CAROTID NEURO PACK, Medline Kit Number/SKU DYNJ44926G; 2) VP SHUNT CDS, Medline Kit Number/SKU CDS983800J; 3) VP SHUNT CDS, Medline Kit Number/SKU CDS983800K.

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

ALL 50 STATES
▸Full report

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

Recall #:
98994
Lot/product code:
Medline Kit Number/SKU DYNJ44926G: UDI/DI 10193489766554 (each), 40193489766555 (case), Lot Number 24EBH848; Medline Kit Number/SKU DYNJ44926G: UDI/DI 10193489766554 (each), 40193489766555 (case), Lot Number 24DBK995; Medline Kit Number/SKU DYNJ44926G: UDI/DI 10193489766554 (each), 40193489766555 (case), Lot Number 23JBP023; Medline Kit Number/SKU DYNJ44926G: UDI/DI 10193489766554 (each), 40193489766555 (case), Lot Number 23HBR067; Medline Kit Number/SKU DYNJ44926G: UDI/DI 10193489766554 (each), 40193489766555 (case), Lot Number 23FBM330; Medline Kit Number/SKU DYNJ44926G: UDI/DI 10193489766554 (each), 40193489766555 (case), Lot Number 23EBK061; Medline Kit Number/SKU DYNJ44926G: UDI/DI 10193489766554 (each), 40193489766555 (case), Lot Number 22JBG042; Medline Kit Number/SKU DYNJ44926G: UDI/DI 10193489766554 (each), 40193489766555 (case), Lot Number 22GBH864; Medline Kit Number/SKU DYNJ44926G: UDI/DI 10193489766554 (each), 40193489766555 (case), Lot Number 22DBT571; Medline Kit Number/SKU CDS983800J: UDI/DI 10195327684662 (each), 40195327684663 (case), Lot Number 25DMJ438; Medline Kit Number/SKU CDS983800J: UDI/DI 10195327684662 (each), 40195327684663 (case), Lot Number 25CMH178; Medline Kit Number/SKU CDS983800J: UDI/DI 10195327684662 (each), 40195327684663 (case), Lot Number 24IME720; Medline Kit Number/SKU CDS983800J: UDI/DI 10195327684662 (each), 40195327684663 (case), Lot Number 24HMG912; Medline Kit Number/SKU CDS983800K: UDI/DI 10198459518973 (each), 40198459518974 (case), Lot Number 26CMC503; Medline Kit Number/SKU CDS983800K: UDI/DI 10198459518973 (each), 40198459518974 (case), Lot Number 26AMB047; Medline Kit Number/SKU CDS983800K: UDI/DI 10198459518973 (each), 40198459518974 (case), Lot Number 25JME109.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 4, 2026

MEDLINE Medical Procedure Kits labeled as: KIT URO ROBOT CYSTECTOMY, D AND C PACK, MAD D & C, VPH LITHOTOMY MINOR, TRMC- PERI GYN PACK, RICH MINOR LITHOTOMY, etc. (see recall documents for a full list of products)

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

ALL 50 STATES
▸Full report

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

Recall #:
98994
Lot/product code:
Medline Kit Number/SKU DYNJ83242B: UDI/DI 10198459157028 (each), 40198459157029 (case), Lot Number 25HBR321; Medline Kit Number/SKU DYNJ83242B: UDI/DI 10198459157028 (each), 40198459157029 (case), Lot Number 25GBD202; Medline Kit Number/SKU DYNJ83242B: UDI/DI 10198459157028 (each), 40198459157029 (case), Lot Number 25FBK813; Medline Kit Number/SKU DYNJ83242B: UDI/DI 10198459157028 (each), 40198459157029 (case), Lot Number 25EBG207; Medline Kit Number/SKU DYNJ61059B: UDI/DI 10195327193454 (each), 40195327193455 (case), Lot Number 23FBK499; Medline Kit Number/SKU DYNJ61059B: UDI/DI 10195327193454 (each), 40195327193455 (case), Lot Number 23EBV071; Medline Kit Number/SKU DYNJ61059B: UDI/DI 10195327193454 (each), 40195327193455 (case), Lot Number 22KBK089; Medline Kit Number/SKU DYNJ61059B: UDI/DI 10195327193454 (each), 40195327193455 (case), Lot Number 22IBV707; Medline Kit Number/SKU DYNJ61059B: UDI/DI 10195327193454 (each), 40195327193455 (case), Lot Number 22HBC310; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 26DMG168; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 26CMD637; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 25KMC849; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 25JMA672; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 25DMC189; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 25CMH655; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 25CMC735; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 24KMA168; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 24IMD969; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 24GMF018; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 24EMA387; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 23LBR964; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 23KBR832; Medline Kit Number/SKU DYNJ61059C: UDI/DI 10195327451653 (each), 40195327451654 (case), Lot Number 23JBE549; Medline Kit Number/SKU DYNJT2135D: UDI/DI 10889942399239 (each), 40889942399230 (case), Lot Number 21LME546; Medline Kit Number/SKU DYNJT2135D: UDI/DI 10889942399239 (each), 40889942399230 (case), Lot Number 21KMG048; Medline Kit Number/SKU DYNJT2135D: UDI/DI 10889942399239 (each), 40889942399230 (case), Lot Number 21JMH240; Medline Kit Number/SKU DYNJT2135D: UDI/DI 10889942399239 (each), 40889942399230 (case), Lot Number 21IMC541; Medline Kit Number/SKU DYNJT2135D: UDI/DI 10889942399239 (each), 40889942399230 (case), Lot Number 21GMD231; Medline Kit Number/SKU DYNJT2135D: UDI/DI 10889942399239 (each), 40889942399230 (case), Lot Number 21DME148; Medline Kit Number/SKU DYNJT2135D: UDI/DI 10889942399239 (each), 40889942399230 (case), Lot Number 21CMC690; Medline Kit Number/SKU DYNJ51750C: UDI/DI 10195327583781 (each), 40195327583782 (case), Lot Number 25HBB990; Medline Kit Number/SKU DYNJ51750C: UDI/DI 10195327583781 (each), 40195327583782 (case), Lot Number 25FBO533; Medline Kit Number/SKU DYNJ51750C: UDI/DI 10195327583781 (each), 40195327583782 (case), Lot Number 25EBA604; Medline Kit Number/SKU DYNJ51750C: UDI/DI 10195327583781 (each), 40195327583782 (case), Lot Number 25CBB580; Medline Kit Number/SKU DYNJ51750C: UDI/DI 10195327583781 (each), 40195327583782 (case), Lot Number 25ABE166; Medline Kit Number/SKU DYNJ51750C: UDI/DI 10195327583781 (each), 40195327583782 (case), Lot Number 24IBR571; Medline Kit Number/SKU DYNJ51750C: UDI/DI 10195327583781 (each), 40195327583782 (case), Lot Number 24HBU707; Medline Kit Number/SKU DYNJ51750C: UDI/DI 10195327583781 (each), 40195327583782 (case), Lot Number 24HBA096; Medline Kit Number/SKU DYNJ51750C: UDI/DI 10195327583781 (each), 40195327583782 (case), Lot Number 24DBC284; Medline Kit Number/SKU DYNJ51750C: UDI/DI 10195327583781 (each), 40195327583782 (case), Lot Number 24CBF095; Medline Kit Number/SKU DYNJ51750C: UDI/DI 10195327583781 (each), 40195327583782 (case), Lot Number 24BBA310; Medline Kit Number/SKU DYNJ51750C: UDI/DI 10195327583781 (each), 40195327583782 (case), Lot Number 24ABM210; Medline Kit Number/SKU DYNJ58848A: UDI/DI 10193489750089 (each), 40193489750080 (case), Lot Number 21DBB421; Medline Kit Number/SKU DYNJ58848A: UDI/DI 10193489750089 (each), 40193489750080 (case), Lot Number 21BBO116; Medline Kit Number/SKU DYNJ41314: UDI/DI 10884389909201 (each), 40884389909202 (case), Lot Number 21GBR980; Medlin… (truncated, 62445 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 May 4, 2026

MEDLINE Urethral Catheter, Red Rubber Latex, Medline Product Number/SKU (REF), French sizes: 1. DYND13508 - 08 Fr; 2. DYND13510 - 10 Fr; 3. DYND13512 - 12 Fr; 4. DYND13514 - 14 Fr; 5. DYND13515 - 15 Fr; 6. DYND13516 - 16 Fr; 7. DYND13518 - 18 Fr; 8. DYND13520 - 20 Fr; 9. DYND13522 - 22 Fr; 10. DYND13614 - 14 Fr; 11. DYND13616 - 16 Fr.

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

ALL 50 STATES
▸Full report

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

Recall #:
98994
Lot/product code:
1. DYND13508, UDI/DI 10080196031139 (each), 20080196031136 (case); 2. DYND13510, UDI/DI 10080196726462 (each), 40080196726463 (case); 3. DYND13512, UDI/DI 10080196031177 (each), 40080196031178 (case); 4. DYND13514, UDI/DI 10080196726219 (each), 40080196726210 (case); 5. DYND13515, UDI/DI 10080196031214 (each), 40080196031215 (case); 6. DYND13516, UDI/DI 10080196031221 (each), 40080196031222 (case); 7. DYND13518, UDI/DI 10080196031245 (each), 40080196031246 (case); 8. DYND13520, UDI/DI 10080196031252 (each), 40080196031253 (case); 9. DYND13522, UDI/DI 10080196061259 (each), 40080196061250 (case); 10. DYND13614, UDI/DI 10080196031276 (each), 30080196031270 (case); 11. DYND13616, UDI/DI 10888277720879 (each), 20888277720876 (case); ALL LOTS
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 4, 2026

MEDLINE Medical Procedure Kits labeled as: 1) D AND C PACK, Medline Kit Number/SKU DYNJ53973C; 2) PK CUST CV A&B CABRINI CO, Medline Kit Number/SKU DYNJ60583C.

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

ALL 50 STATES
▸Full report

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

Recall #:
98994
Lot/product code:
Medline Product Number/SKU DYNJ53973C: UDI/DI 10195327008864 (each), 40195327008865 (case), Lot Number 21KME435; Medline Product Number/SKU DYNJ53973C: UDI/DI 10195327008864 (each), 40195327008865 (case), Lot Number 21JMC247; Medline Product Number/SKU DYNJ53973C: UDI/DI 10195327008864 (each), 40195327008865 (case), Lot Number 21JMB678; Medline Product Number/SKU DYNJ53973C: UDI/DI 10195327008864 (each), 40195327008865 (case), Lot Number 21IMH919; Medline Product Number/SKU DYNJ60583C: UDI/DI 10195327605582 (each), 40195327605583 (case), Lot Number 24CBO389; Medline Product Number/SKU DYNJ60583C: UDI/DI 10195327605582 (each), 40195327605583 (case), Lot Number 24ABR872.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 4, 2026

MEDLINE Medical Procedure Kits labeled as: BILAT MICRO VASECTOMY REVERSAL, Medline Kit Number/SKU DYNJ68302

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

ALL 50 STATES
▸Full report

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

Recall #:
98994
Lot/product code:
UDI/DI 10193489820478 (each), 40193489820479 (case), Lot Numbers: 24CBL413, 24ABX694, 23JBY172, 23IBI716, 23DBG873, 23BBR326, 23ABH376, 22KBS634, 22JBS743, 22FBT429, 22BBZ842, 22BBK836, 21BBG579, 21ABO658.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 4, 2026

MEDLINE Medical Procedure Kits labeled as: ORAL RESTORATION, Medline Kit Number/SKUDYNJ86253A

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

ALL 50 STATES
▸Full report

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

Recall #:
98994
Lot/product code:
UDI/DI 10198459556654 (each), 40198459556655 (case). Lot Numbers: 25KBC063, 25JBO955.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 4, 2026

MEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag, 14 Fr, 1000mL, Medline Product Number/SKU (REF) URO4RR14C

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

ALL 50 STATES
▸Full report

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

Recall #:
98994
Lot/product code:
UDI/DI 10197344148998 (each), 20197344148995 (case); ALL LOTS
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 4, 2026

MEDLINE Medical Procedure Kits labeled as CH OPEN HEART, ADULT CARDIAC KIT, AHT CVOR CABG, APH EMERGENCY OPEN HEART PACK, Etc. (see recall documents for a full list of products)

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

ALL 50 STATES
▸Full report

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

Recall #:
98994
Lot/product code:
Medline Kit Number/SKU CDS983773G: UDI/DI 10193489344240 (each), 40193489344241 (case), Lot Number 21ABD933; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 22IBJ338; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 22EBL456; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 22EBL231; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 22BBW955; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 22ABC123; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 21IBM442; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 21IBI539; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 21FBT730; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 21EBA066; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 21CBW872; Medline Kit Number/SKU CDS983773J: UDI/DI 10195327233617 (each), 40195327233618 (case), Lot Number 23HBV936; Medline Kit Number/SKU CDS983773J: UDI/DI 10195327233617 (each), 40195327233618 (case), Lot Number 23HBL135; Medline Kit Number/SKU CDS983773J: UDI/DI 10195327233617 (each), 40195327233618 (case), Lot Number 23HBH924; Medline Kit Number/SKU CDS983773J: UDI/DI 10195327233617 (each), 40195327233618 (case), Lot Number 23GBT133; Medline Kit Number/SKU CDS983773J: UDI/DI 10195327233617 (each), 40195327233618 (case), Lot Number 23GBD523; Medline Kit Number/SKU CDS983773J: UDI/DI 10195327233617 (each), 40195327233618 (case), Lot Number 23ABM749; Medline Kit Number/SKU CDS983773J: UDI/DI 10195327233617 (each), 40195327233618 (case), Lot Number 22JBH775; Medline Kit Number/SKU DYNJ39755A: UDI/DI 10193489670233 (each), 40193489670234 (case), Lot Number 24EDB118; Medline Kit Number/SKU DYNJ39755A: UDI/DI 10193489670233 (each), 40193489670234 (case), Lot Number 24DDC044; Medline Kit Number/SKU DYNJ39755A: UDI/DI 10193489670233 (each), 40193489670234 (case), Lot Number 24BDB774; Medline Kit Number/SKU DYNJ39755A: UDI/DI 10193489670233 (each), 40193489670234 (case), Lot Number 24ADB944; Medline Kit Number/SKU DYNJ39755A: UDI/DI 10193489670233 (each), 40193489670234 (case), Lot Number 24ADA835; Medline Kit Number/SKU DYNJ39755A: UDI/DI 10193489670233 (each), 40193489670234 (case), Lot Number 24ADA564; Medline Kit Number/SKU DYNJ39755A: UDI/DI 10193489670233 (each), 40193489670234 (case), Lot Number 23KDB417; Medline Kit Number/SKU DYNJ39755A: UDI/DI 10193489670233 (each), 40193489670234 (case), Lot Number 21KDB767; Medline Kit Number/SKU DYNJ39755A: UDI/DI 10193489670233 (each), 40193489670234 (case), Lot Number 21IDC416; Medline Kit Number/SKU DYNJ39755A: UDI/DI 10193489670233 (each), 40193489670234 (case), Lot Number 24BDB595; Medline Kit Number/SKU DYNJ39755A: UDI/DI 10193489670233 (each), 40193489670234 (case), Lot Number 24ADB653; Medline Kit Number/SKU DYNJ39755A: UDI/DI 10193489670233 (each), 40193489670234 (case), Lot Number 22DDA063; Medline Kit Number/SKU DYNJ46712: UDI/DI 10888277252998 (each), 40888277252999 (case), Lot Number 23JBQ990; Medline Kit Number/SKU DYNJ46712: UDI/DI 10888277252998 (each), 40888277252999 (case), Lot Number 23GBS121; Medline Kit Number/SKU DYNJ46712: UDI/DI 10888277252998 (each), 40888277252999 (case), Lot Number 22HBB007; Medline Kit Number/SKU DYNJ46712: UDI/DI 10888277252998 (each), 40888277252999 (case), Lot Number 22FBC016; Medline Kit Number/SKU DYNJ46712: UDI/DI 10888277252998 (each), 40888277252999 (case), Lot Number 22BBE079; Medline Kit Number/SKU DYNJ46712: UDI/DI 10888277252998 (each), 40888277252999 (case), Lot Number 22ABJ835; Medline Kit Number/SKU DYNJ46712: UDI/DI 10888277252998 (each), 40888277252999 (case), Lot Number 21IBG139; Medline Kit Number/SKU DYNJ46712: UDI/DI 10888277252998 (each), 40888277252999 (case), Lot Number 21BBA612; Medline Kit Number/SKU DYNJ46712: UDI/DI 10888277252998 (each), 40888277252999 (case), Lot Number 21ABU423; Medline Kit Number/SKU DYNJ46712: UDI/DI 10888277252998 (each), 40888277252999 (case), Lot Number 21ABP812; Medline Kit Number/SKU DYNJ905177B: UDI/DI 10193489940497 (each), 40193489940498 (case), Lot Number 21LMG772; Medline Kit Number/SKU DYNJ905177B: UDI/DI 10193489940497 (each), 40193489940498 (case), Lot Number 21LMF805; Medline Kit Number/SKU DYNJ905177B: UDI/DI 10193489940497 (each), 40193489940498 (case), Lot Number 21KMD456; Medline Kit Number/SKU DYNJ905177B: UDI/DI 10193489940497 (each), 40193489940498 (case), Lot Number 21KMC752; Medline Kit Number/SKU DYNJ905177B: UDI/DI 10193489940497 (each), 40193489940498 (case), Lot Number 21KMA494; Medline Ki… (truncated, 591332 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 May 4, 2026

MEDLINE Medical Procedure Kits labeled as: ADULT TRACHEOSTOMY TUBE INSERT, ASC T&A, CONWAY T&A SINUS, EAR PACK, etc. (see the recall documents for the full list of products)

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

ALL 50 STATES
▸Full report

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

Recall #:
98994
Lot/product code:
Medline Kit Number/SKU MNS12180: UDI/DI 10653160327134 (each), 40653160327135 (case), Lot Number 22FBM309; Medline Kit Number/SKU MNS12180: UDI/DI 10653160327134 (each), 40653160327135 (case), Lot Number 22DBJ094; Medline Kit Number/SKU MNS12180: UDI/DI 10653160327134 (each), 40653160327135 (case), Lot Number 22OBH091; Medline Kit Number/SKU MNS12180: UDI/DI 10653160327134 (each), 40653160327135 (case), Lot Number 21HBC428; Medline Kit Number/SKU DYNJ67109B: UDI/DI 10195327207083 (each), 40195327207084 (case), Lot Number 24ABC426; Medline Kit Number/SKU DYNJ67109B: UDI/DI 10195327207083 (each), 40195327207084 (case), Lot Number 23JBM836; Medline Kit Number/SKU DYNJ67109B: UDI/DI 10195327207083 (each), 40195327207084 (case), Lot Number 23HBS357; Medline Kit Number/SKU DYNJ67109B: UDI/DI 10195327207083 (each), 40195327207084 (case), Lot Number 22KBS784; Medline Kit Number/SKU DYNJ67109B: UDI/DI 10195327207083 (each), 40195327207084 (case), Lot Number 22IBV574; Medline Kit Number/SKU DYNJ67109D: UDI/DI 10195327689100 (each), 40195327689101 (case), Lot Number 26ABH211; Medline Kit Number/SKU DYNJ67109D: UDI/DI 10195327689100 (each), 40195327689101 (case), Lot Number 25GBS702; Medline Kit Number/SKU DYNJ67109D: UDI/DI 10195327689100 (each), 40195327689101 (case), Lot Number 25EBT418; Medline Kit Number/SKU DYNJ67109D: UDI/DI 10195327689100 (each), 40195327689101 (case), Lot Number 24LBP073; Medline Kit Number/SKU DYNJ67109D: UDI/DI 10195327689100 (each), 40195327689101 (case), Lot Number 24JBI868; Medline Kit Number/SKU DYNJ67109D: UDI/DI 10195327689100 (each), 40195327689101 (case), Lot Number 24HBW417; Medline Kit Number/SKU DYNJ67109D: UDI/DI 10195327689100 (each), 40195327689101 (case), Lot Number 24EBV861; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 26CMK753; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 26BMF647; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 26BMB840; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 25KMD227; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 25JMB620; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 25HME486; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 25GMA169; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 25EME427; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 25CMG490; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 25BMC915; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 25AMD126; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 24KMJ170; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 24KMA267; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 24IMH206; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 24HMI841; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 24HMA214; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 24FMH462; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 24EMJ672; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 24EME216; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 24DMK415; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 24CMA079; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 24BMG449; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 24BMC569; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 23LME699; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 23JMD593; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 23HMI241; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 23HMB780; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 23GMD384; Medline Kit Number/SKU PHS41719A: UDI/DI 10193489784824 (each), 40193489784825 (case), Lot Number 23EMB734; Medline Kit Number/SKU PHS41719A: UDI/DI … (truncated, 291828 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 May 1, 2026

Brand Name: CGuard Prime Carotid Stent System, 135cm, 8mmx30mm Model/Catalog Number: CND0830

Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.

ALL 50 STATES
▸Full report

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

Recall #:
98922
Lot/product code:
UDI: 07290120281691; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026
Recalling firm:
INSPIREMD Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 1, 2026

Brand Name: CGuard Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840

Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.

ALL 50 STATES
▸Full report

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

Recall #:
98922
Lot/product code:
UDI: 07290120281707; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026
Recalling firm:
INSPIREMD Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 1, 2026

Brand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm Model/Catalog Number: CND0940

Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.

ALL 50 STATES
▸Full report

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

Recall #:
98922
Lot/product code:
UDI: 07290120281745; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026
Recalling firm:
INSPIREMD Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 1, 2026

CGuard Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND1040

Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.

ALL 50 STATES
▸Full report

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

Recall #:
98922
Lot/product code:
UDI: 07290120281783; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026
Recalling firm:
INSPIREMD Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 1, 2026

Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 6600-1461-500

GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain conditions, for example, impact during transport, one or more of the fasteners that secure the soffit can disengage. If this occurs, a fastener could fall into the patient compartment. In rare circumstances, if multiple fasteners disengage, the canopy soffit can become loose or detach. These conditions could potentially result in patient injury.

ALL 50 STATES
▸Full report

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

Recall #:
98986
Lot/product code:
Serial Numbers: 5452896 801057486 800977619 801093759 5584569 5587625 5367527 5603110 5371240 5497382
Recalling firm:
GE Medical Systems, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 1, 2026

Giraffe OmniBed, a combination of an infant incubator and an infant warmer, All Models

GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain conditions, for example, impact during transport, one or more of the fasteners that secure the soffit can disengage. If this occurs, a fastener could fall into the patient compartment. In rare circumstances, if multiple fasteners disengage, the canopy soffit can become loose or detach. These conditions could potentially result in patient injury.

ALL 50 STATES
▸Full report

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

Recall #:
98986
Lot/product code:
Serial Numbers: HDGP50034 HDGP51018 HDGS50069 HDGS50070 HDGS50074 HDGS50077 HDGS50158 HDGS50162 HDGS52245 HDGS52286 HDGT50374 HDGT50399 HDGS50464 HDGS50560 HDGS50569 HDGS50570 HDGD50349 HDGG54079 HDGJ50278 HDGJ50281 HDGJ50390 HDGJ50391 HDGJ50394 HDGJ50400 HDGK52363 HDGM50481 HDGM50482 HDGM50483 HDGM50484 HDGM50485 HDGM50486 HDGQ50625 HDGQ50626 HDGQ50627 HDGQ50628 HDGQ50629 HDGS50369 HDGS50370 HDGS50371 HDGS50372 HDGR50086 HDGL51597 HDGG54268 HDGG54270 HDGG54410 HDGK51696 HDGL51002 HDGL51003 HDGL51004 HDGL51005 HDGL51032 HDGN50383 HDGP50522 HDGQ50763 HDGQ50882 HDGQ50884 HDGQ50886 HDGQ50887 HDGQ50901 HDGQ50902 HDGQ50903 HDGQ50904 HDGQ50905 HDGQ50906 HDGQ50907 HDGQ50908 HDGQ50909 HDGQ50910 HDGQ50911 HDGQ50912 HDGQ50913 HDGQ50917 HDGS51833 HDGU60609 HDGU60732 HDGE50297 HDGE50370 HDGE50371 HDGK51791 HDGK51792 HDGK51793 HDGK51794 HDGK51795 HDGK51804 HDGK51822 HDGK51840 HDGR50087 HDGR50088 HDGR50178 HDGR50180 HDGR50184 HDGR50185 HDGN50863 HDGN50864 HDGN50865 HDGN50866 HDGN50868 HDGN50869 HDGN50870 HDGH60335 HDGH60316 HDGH60319 HDGH60320 HDGH60321 HDGH60322 HDGH60323 HDGH60324 HDGH60326 HDGH60327 HDGH60328 HDGH60329 HDGH60330 HDGH60331 HDGH60333 HDGH60334 HDGH60403 HDGH60407 HDGH60408 HDGH60409 HDGN50867 HDGT50420 HDGK51412 HDGK51706 HDGK52164 HDGL50039 HDGL51294 HDGL51483 HDGL51486 HDGM51574 HDGM51575 HDGM51583 HDGP51029 HDGS52343 HDGS52358 HDGJ50055 HDGN50393 HDGM50726 HDGM50093 HDGM50146 HDGM50149 HDGM50151 HDGP51237 HDGP51290 HDGP51297 HDGQ51823 HDGQ51947 HDGJ51132 HDGJ51133 HDGJ51134 HDGJ51136 HDGJ51142 HDGJ51176 HDGJ51177 HDGJ51180 HDGJ51181 HDGJ51182 HDGJ51189 HDGJ51190 HDGL50080 HDGL50082 HDGL50123 HDGL50165 HDGR52333 HDGS50800 HDGS50812 HDGU60084 HDGU60087 HDGU60098 HDGU60157 HDGU60158 HDGU60162 HDGU60168 HDGU60598 HDGT50753 HDGT50754 HDGT50756 HDGT50757 HDGU60516 HDGU60520 HDGU60523 HDGU60527 HDGU60528 HDGU60533 HDGU60535 HDGU60540 HDGU60542 HDGU60543 HDGJ51045 HDGJ51079 HDGQ50791 HDGR52718 HDGR52936 HDGL51165 HDGL51190 HDGM51272 HDGM51289 HDGN51296 HDGN51337 HDGP50832 HDGP50839 HDGT50381 HDGT50382 HDGL51672 HDGN51051 HDGN51096 HDGR50127 HDGR50143 HDGS50619 HDGS50624 HDGS50629 HDGS50630 HDGG55016 HDGJ50424 HDGJ50427 HDGJ50432 HDGK52226 HDGM50995 HDGM50996 HDGM51000 HDGM51003 HDGM51005 HDGM51009 HDGQ50958 HDGQ50961 HDGQ50963 HDGQ50965 HDGQ50967 HDGR52148 HDGR52150 HDGR52152 HDGR52221 HDGR52246 HDGR52281 HDGR52301 HDGR52310 HDGR52329 HDGR52331 HDGD00113 HDGF50369 HDGF53069 HDGF53072 HDGG55175 HDGH60780 HDGH60781 HDGJ50183 HDGJ50935 HDGJ51027 HDGK51849 HDGM50511 HDGQ51811 HDGS50516 HDGT60443 HDGT60444 HDGT60445 HDGK52275 HDGM50360 HDGM50366 HDGM50374 HDGM50397 HDGM50402 HDGM50416 HDGM50417 HDGM50430 HDGM50438 HDGM50439 HDGM50441 HDGM50448 HDGM50455 HDGM50456 HDGM50473 HDGM50548 HDGM50550 HDGM50552 HDGM50553 HDGM50554 HDGM50555 HDGM50557 HDGM50562 HDGM50564 HDGM50581 HDGM50583 HDGM50595 HDGM50632 HDGM50633 HDGM50634 HDGM50635 HDGM50641 HDGM50642 HDGM50646 HDGM50648 HDGM50649 HDGM50650 HDGM50681 HDGM50686 HDGS52298 HDGM50445 HDGM50643 HDGL50363 HDGL51839 HDGK51331 HDGK51348 HDGL51846 HDGL51847 HDGQ51109 HDGQ51112 HDGQ51116 HDGQ51117 HDGS50785 HDGS50787 HDGS52365 HDGS52369 HDGT60089 HDGT60113 HDGL50427 HDGL50628 HDGS50005 HDGS50010 HDGN50437 HDGN50586 HDGN50588 HDGN50590 HDGN50591 HDGN50592 HDGN50593 HDGN50594 HDGN50606 HDGN50793 HDGG54096 HDGG54099 HDGG54100 HDGL51851 HDGL51857 HDGL51858 HDGP50025 HDGQ51891 HDGT50691 HDGM50788 HDGM50789 HDGN50790 HDGH61006 HDGS50355 HDGS50755 HDGH60898 HDGE50352 HDGJ50127 HDGJ50133 HDGJ50393 HDGJ50396 HDGJ50397 HDGJ50399 HDGJ50401 HDGJ50404 HDGJ50405 HDGT50740 HDGJ50654 HDGJ50657 HDGG54196 HDGH60133 HDGH60485 HDGH60505 HDGH60571 HDGJ50175 HDGK51252 HDGK51350 HDGS51933 HDGS51974 HDGS52066 HDGS52088 HDGS52149 HDGS52151 HDGK51230 HDGK51232 HDGK52080 HDGK52081 HDGK52189 HDGK52190 HDGK52194 HDGK52195 HDGK52263 HDGN51268 HDGN51306 HDGN51308 HDGJ51212 HDGL51827 HDGM51259 HDGM51356 HDGM51360 HDGN50309 HDGP50101 HDGU60725 HDGU60731 HDGU60735 HDGU60840 HDGU60863 HDGU60881 HDGU63034 HDGU63201 HDGU63220 HDGU63222 HDGQ50008 HDGQ50079 HDGU60441 HDGM52234 HDGN50198 HDGP50027 HDGP50031 HDGP50032 HDGP50048 HDGP50050 HDGP50053 HDGP50055 HDGP50057 HDGP50073 HDGP50075 HDGP50077 HDGP50083 HDGP50084 HDGP50087 HDGP50089 HDGP50092 HDGP50110 HDGP50111 HDGP50112 HDGP50114 HDGP50115 HDGP50118 HDGP50122 HDGP50127 HDGL51643 HDGL51802 HDGM50104 HDGM50131 HDGM50133 HDGM50137 HDGM50138 HDGM50139 HDGM50140 HDGM50142 HDGM50143 HDGM50144 HDGS50191 HDGS50200 HDGS50780 HDGT50540 HDGK52422 HDGK52604 HDGL50012 HDGL50019 HDGL50020 HDGL50106 HDGL50733 HDGM50465 HDGM50663 HDGM50664 HDGM50702 HDGP51156 HDGQ51070 HDGQ51711 HDGS51245 HDGS51585 HDGS51588 HDGS51592 HDGS51593 HDGS51595 HDGS51600 HDGS51604 HDGS52370 HDGS52377 HDGS52380 HDGS52384 HDGS52385 HDGG54025 HDGH60268 HDGN50587 HDGN50598 HDGQ51194 HDGU60074 HDGU60075 HDGV60169 HDGE50372 HDGG54306 HDGG55066 HDGM51909 HDGL51449 HDGN50490 HDGQ50500 HDGQ51524 HDGQ51722 HDGQ51723 HDGQ51724 HDGQ51725 HDGQ51726 HDGQ51727 HDGQ51728 HDGQ51729 HDGQ51730 HDGQ51732 HDGT60589 HDGT… (truncated, 195891 characters total — see the official FDA record for the full value)
Recalling firm:
GE Medical Systems, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 1, 2026

Giraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1, a combination of an infant incubator and an infant warmer, Model Numbers 2082844-001-XXX

GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain conditions, for example, impact during transport, one or more of the fasteners that secure the soffit can disengage. If this occurs, a fastener could fall into the patient compartment. In rare circumstances, if multiple fasteners disengage, the canopy soffit can become loose or detach. These conditions could potentially result in patient injury.

ALL 50 STATES
▸Full report

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

Recall #:
98986
Lot/product code:
UDI-DI: 010084068211686221; Serial Numbers: TAB24430068SA TAB24430069SA TAB24430070SA TAB24430071SA TAB26011006SA TAB26011009SA TAB26021001SA TAB26061022SA TABW63370 TAB24300033SA TABV60214 TABW63378 TAB24240010SA TABV62327 TABA70043 TABA70053 TABA70054 TABA70055 TABZ72515 TABV60081 TABV60219 TABV60221 TABV60223 TABV60224 TAB25351023SA TAB25501502SA TAB25501503SA TAB25501530SA TAB25501531SA TAB26021501SA TAB26021503SA TAB26101502SA TAB26101503SA TAB26101507SA TAB26101509SA TAB26101510SA TAB26101511SA TAB26101512SA TAB26101513SA TAB26101515SA TAB26101516SA TAB26101517SA TAB26101519SA TAB26101520SA TAB26101521SA TABX63854 TABX63855 TABX63856 TAB25111019SA TAB24160010SA TABY70926 TABY70987 TABX63393 TAB24280002SA TABV60007 TABV60203 TABW63326 TABX62677 TABX62757 TABX63717 TABX63718 TABY71177 TAB24180045SA TAB24180046SA TAB24180047SA TAB24280001SA TAB25081073SA TAB25081074SA TABB70452 TABB70464 TABB70550 TABB70572 TABX63665 TABX63769 TABX63776 TAB24330009SA TAB24330010SA TAB24330011SA TAB24330012SA TAB24330013SA TAB24330014SA TAB24330015SA TAB24330016SA TAB24330017SA TAB24330018SA TAB24330021SA TAB24430028SA TAB25101068SA TAB25101069SA TAB25101070SA TAB25101071SA TAB25101072SA TAB25101073SA TAB25101074SA TAB25101075SA TAB25101076SA TAB25101077SA TAB25101078SA TAB25101079SA TAB25101080SA TAB25101081SA TAB25101082SA TAB25101083SA TAB25111000SA TAB25111001SA TAB25111002SA TAB25111003SA TAB25111004SA TAB25111009SA TAB25111010SA TAB25111011SA TAB25111012SA TAB25111013SA TAB25421013SA TAB25421014SA TAB25421015SA TAB25421016SA TABX62269 TABZ70640 TAB26061051SA TAB26071039SA TAB26081028SA TAB26081035SA TAB26081042SA TABW62610 TABW62689 TABW62731 TABX62268 TABX63359 TABX63374 TABX63603 TABX63614 TABX63616 TABA71644 TABA71768 TABW63180 TABZ70669 TAB24500004SA TAB24500005SA TAB24500006SA TAB24500007SA TAB25121048SA TABV61088 TABV61128 TABV61129 TABV61130 TABV61295 TABV61301 TABV61306 TABV61313 TABV61326 TABV61333 TABV61335 TABV61336 TABV61338 TABV61350 TABV61352 TABV61355 TABV61361 TABV61362 TABV61364 TAB24370088SA TAB24370090SA TABX70343 TABX70377 TABW62806 TABX63694 TABX63739 TABX63748 TABW63195 TABW63196 TABX62758 TAB23410035SA TAB23410063SA TAB23410064SA TAB24360011SA TAB25341076SA TAB25341077SA TAB25341078SA TAB24230074SA TAB24230075SA TAB24230077SA TAB24230078SA TAB24230079SA TAB24460003SA TAB24460005SA TAB24460007SA TAB24460008SA TAB24460009SA TAB25521016SA TAB24120011SA TAB24120019SA TAB24120021SA TAB24120035SA TAB24120063SA TAB24120064SA TAB26101041SA TAB26101042SA TABA70815 TABA70817 TABA70820 TAB25020018SA TABA71786 TABA71790 TABA71793 TABA71797 TABA71801 TAB23400025SA TAB24280015SA TABW62703 TABW62757 TABY71094 TABY71114 TABY71176 TABY71277 TABY71368 TABY71624 TABY71628 TABY71633 TABY71647 TABY71650 TABY71652 TABY71659 TABW63827 TAB24430050SA TAB24430051SA TAB24430052SA TAB24430053SA TAB24430054SA TABB70738 TABV60044 TABV60090 TABW62244 TABX62370 TABX63373 TABX63563 TABY71172 TABY71173 TABY71175 TAB24420005SA TAB24420006SA TAB24420007SA TABB70847 TABB71365 TABB71501 TABB71514 TABB71548 TABB71550 TABB71551 TABB71573 TABB71574 TABB71575 TABB71576 TABB71611 TABB71614 TABB71617 TABB71618 TABB71620 TAB23410042SA TAB23450037SA TAB23470001SA TAB23470007SA TAB23480027SA TAB23480028SA TAB23480030SA TAB23480035SA TAB23480037SA TAB23480038SA TAB23480039SA TAB23480040SA TAB22340001SA TAB24060005SA TAB24420088SA TAB24430012SA TAB24430013SA TAB24430014SA TAB24430016SA TAB24430017SA TAB24430018SA TAB24430019SA TAB24430020SA TAB24430021SA TAB24430022SA TAB24430023SA TAB24430024SA TAB24430025SA TAB24430026SA TAB24430027SA TAB24440001SA TAB24440003SA TAB24440004SA TAB24440005SA TAB24440006SA TAB24440007SA TAB24440008SA TAB24440010SA TAB24440011SA TAB24440012SA TAB24440013SA TAB24440014SA TAB24440015SA TAB24440016SA TABA70297 TAB24430034SA TAB24370093SA TAB24370099SA TAB24370101SA TAB24370102SA TAB24370103SA TAB24370104SA TAB24370105SA TAB24370106SA TAB24370107SA TAB24370108SA TAB24370109SA TAB24370110SA TAB24370111SA TAB24370112SA TAB24370113SA TAB24370114SA TAB24370115SA TAB24370116SA TAB24370117SA TAB24370118SA TAB24380054SA TAB24380055SA TAB24380056SA TAB24380057SA TAB24380058SA TAB24380059SA TAB24380060SA TAB24380061SA TAB24380062SA TAB24380063SA TAB24380064SA TAB24380065SA TAB24380066SA TAB24380067SA TAB24380068SA TAB24380079SA TAB24380082SA TAB24380083SA TAB24380084SA TAB24380085SA TAB24380086SA TAB24380087SA TAB24380088SA TAB24380089SA TAB24380090SA TAB24380091SA TAB24380092SA TAB24380093SA TAB24380094SA TAB24380095SA TAB24380096SA TAB24380097SA TAB24380098SA TAB24380121SA TAB24420010SA TAB24420012SA TAB24420013SA TAB24420015SA TAB24420072SA TABB71176 TABB71809 TABB71813 TAB24200067SA TAB24380113SA TAB24420016SA TAB24420017SA TAB24420018SA TAB24420019SA TAB24420020SA TAB24420021SA TAB24420022SA TAB24420023SA TAB24420024SA TAB24420025SA TAB24420027SA TAB24420028SA TAB24420029SA TAB24420030SA TAB24420031SA TAB24420032SA TAB24380102SA TAB24380103SA TAB24380104SA TAB24380105SA TAB24380106SA TAB24380107SA TAB24380111SA TAB244… (truncated, 269577 characters total — see the official FDA record for the full value)
Recalling firm:
GE Medical Systems, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 1, 2026

CGuard Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND1040

Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.

ALL 50 STATES
▸Full report

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

Recall #:
98922
Lot/product code:
UDI: 07290120281783; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026
Recalling firm:
INSPIREMD Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodAllergenUndeclaredRecalled May 1, 2026

SECOND NATURE KETO CRUNCH SMART MIX, 10-ounce retail-sized plastic pouch, UPC 077034013405, 6-10oz units per case.

The product may contain not listed on the label allergens (cashews, pistachios), and dried cherries.

ALL 50 STATES
▸Full report

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

Recall #:
H-0905-2026
Lot/product code:
Best if Used By: 2/12/2027
Recalling firm:
SECOND NATURE BRAND
Resolved:
August 21, 2026
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled May 1, 2026

Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-203-01; Individual Dose NDC: 68084-203-11

Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

ALL 50 STATES
▸Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0536-2026
Lot/product code:
Lot#: 1027583, Exp 09/30/2027
Recalling firm:
Amerisource Health Services LLC
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled May 1, 2026

Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-202-01; Individual Dose NDC: 68084-202-11

Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

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A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0537-2026
Lot/product code:
Lot 1028739, exp 12/31/2027; Lot 1025622, exp 06/30/2027
Recalling firm:
Amerisource Health Services LLC
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UnclassifiedRisk not yet known
Medical deviceRecalled May 1, 2026

CGuard Prime Carotid Stent System, 135cm, 9mx30mm Model/Catalog Number: CND0930

Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.

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

Recall #:
98922
Lot/product code:
UDI: 07290120281738; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026
Recalling firm:
INSPIREMD Inc
View official FDA record (opens in a new tab)