openFDA

Tracking U.S. FDA recalls

The most serious (Class I/II) FDA recalls of medical devices, drugs, and food, summarized with sources. Data from openFDA. This site is not an official U.S. government website.

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High-severity recalls explained with key points, FAQs, and sources.

Class I (most serious) Medical Device 2026/06/03

FDA Class I recall: alarm and electrical faults in the controller (AIC) for the Impella heart pump — distributed worldwide (Abiomed)

Abiomed recalled the Automated Impella Controller (AIC), the console for its Impella circulatory-support pump, after identifying alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current sensing. The FDA classified it Class I, the most serious. Distributed across the U.S. and Europe.

Impella circulatory-support pump controller (AIC): alarm, power, short-circuit, and motor-sensing faults
Purge-cassette misalignment can cause a piston block, requiring a switch to a backup console
FDA classified it Class I (Z-2238-2026, reported June 3, 2026, ongoing)

Class I (most serious) Food 2026/06/03

FDA Class I recall: bagel crisps may be contaminated with Salmonella — a cascade from recalled milk powder (Legacy Bakehouse)

Legacy Bakehouse recalled "Butter Parsley Bagel Crisps" because they were made with milk powder (from California Dairies) that had itself been recalled for Salmonella. The FDA classified it Class I, the most serious. An example of a contaminated ingredient cascading into many downstream products.

Bagel crisps recalled because made with recalled milk powder
FDA classified it Class I (H-0850-2026, reported June 3, 2026, ongoing)
Cause: used California Dairies milk powder recalled for Salmonella

Class I (most serious) Food 2026/06/03

FDA Class I recall: Wawa bottled iced tea has an undeclared milk allergen — a serious risk for those with milk allergy

Wawa's bottled "Diet Iced Tea Lemon" (16oz) was recalled for an undeclared milk allergen. The FDA classified it Class I, the most serious. People with a milk allergy who trust the label could suffer a severe reaction.

Wawa bottled "Diet Iced Tea Lemon (16oz)" recalled for an undeclared milk allergen
FDA classified it Class I (H-0856-2026, reported June 3, 2026, ongoing)
Distributed in DE, MD, NJ, PA, VA; similar recalls cover other Wawa bottled drinks

Class I (most serious) Drug 2026/05/27

FDA Class I recall: Staphylococcus aureus in MG217 skin cream — microbial contamination of a non-sterile product

Wisconsin Pharmacal recalled an over-the-counter MG217 multi-symptom treatment cream (colloidal oatmeal 2%) after confirming the presence of Staphylococcus aureus. The FDA classified it Class I.

Staphylococcus aureus in MG217 skin cream (colloidal oatmeal 2%)
FDA classified it Class I (D-0553-2026, reported May 27, 2026, ongoing)
Microbial contamination of a non-sterile product; about 690 tubes, U.S. and Bahamas

Class I (most serious) Food 2026/05/27

FDA Class I recall: uncontrolled Clostridium botulinum hazard in vacuum-packed kippered herring — botulism risk

Shining Sea Fish recalled vacuum-packed kippered herring over an uncontrolled Clostridium botulinum (botulism) hazard. The FDA classified it Class I. Vacuum-packed, low-oxygen seafood is a classic botulism risk.

Uncontrolled Clostridium botulinum (botulism) hazard in vacuum-packed kippered herring
FDA classified it Class I (H-0810-2026, reported May 27, 2026, ongoing)
About 675 pounds, distributed in Michigan, firm-initiated (initiated April 28, 2026)

Class I (most serious) Food 2026/05/27

FDA Class I recall: possible Salmonella in Ghirardelli frappe mix — distribution includes Japan, tied to recalled milk powder

Ghirardelli recalled commercial frappe mixes (containing nonfat dry milk) over possible Salmonella contamination. The FDA classified it Class I. Distribution includes Japan. In late May 2026, many Class I food recalls cited Salmonella, several tied to a contaminated milk-powder ingredient.

Possible Salmonella in Ghirardelli commercial frappe mix (with nonfat dry milk)
FDA classified it Class I (H-0841-2026, reported May 27, 2026, ongoing)
Distribution includes Japan (plus 26+ U.S. states and Canada/Guatemala/Philippines)

Class I (most serious) Medical Device 2026/05/20

FDA Class I recall: particulate in Medline cardiac-catheter manifolds (Namic) — distribution includes Japan

Medline recalled medical kits containing Namic manifolds (used in cardiac catheterization / angiography) after identifying particulate within the manifolds' fluid path. The FDA classified it Class I, the most serious. Distribution includes Japan.

Particulate identified in the fluid path of Namic manifolds used in cardiac-cath / angiography kits
FDA classified it Class I (recall Z-2147-2026, reported May 20, 2026, ongoing)
About 21,119 kits; firm-initiated (recall initiated March 24, 2026)

Class I (most serious) Drug 2026/05/13

FDA Class I recall: particulate matter in B. Braun Lactated Ringer's injection (IV) — ~95,000 units nationwide

B. Braun Medical recalled Lactated Ringer's Injection (1000 mL) over the presence of particulate matter. The FDA classified it Class I. About 95,412 units are affected, distributed U.S. nationwide. Particulate in injectables can cause serious harm.

Particulate matter in B. Braun Lactated Ringer's injection (1000 mL, Rx)
FDA classified it Class I (D-0540-2026, reported May 13, 2026, ongoing)
About 95,412 units, distributed U.S. nationwide, firm-initiated (initiated April 28, 2026)

Class II Food 2026/06/03

FDA Class II recall: popular brand Fly By Jing noodles may have peanut cross-contamination (undeclared allergen)

Fly By Jing's "Creamy Sesame Noodles" (3.8oz) were recalled for possible peanut cross-contamination resulting in an undeclared allergen. The FDA classified it Class II. Distributed nationwide. People with a peanut allergy should take note.

Popular brand Fly By Jing's "Creamy Sesame Noodles (3.8oz)" recalled
Reason: possible cross-contamination yielding an undeclared allergen (peanut)
FDA classified it Class II (H-0854-2026, reported June 3, 2026, ongoing)

Class II Drug 2026/05/27

FDA Class II recall: ADHD drug atomoxetine — 25mg mislabeled as "10mg," risking a dosing mix-up

Drug repackager Safecor Health recalled atomoxetine HCl capsules where a 25mg product was mistakenly labeled "10mg." The FDA classified it Class II. Trusting the label could lead a patient to take 2.5× the intended dose.

Atomoxetine (ADHD) capsules: a 25mg product mislabeled as "10mg"
FDA classified it Class II (D-0538-2026, reported May 27, 2026, ongoing)
Trusting the label could mean taking 2.5× the intended dose

Class II Drug 2026/05/27

FDA Class II recall: antibiotic erythromycin tablets exceed the limit for a nitrosamine impurity — nationwide (Zydus)

Generics maker Zydus recalled erythromycin tablets (500mg) after a nitrosamine impurity (N-Nitroso-Desmethyl-Erythromycin) was found above the recommended acceptable intake limit. The FDA classified it Class II. Distributed nationwide.

Erythromycin tablets (500mg) had a nitrosamine impurity above the acceptable limit
Impurity: N-Nitroso-Desmethyl-Erythromycin (caused by a CGMP deviation)
FDA classified it Class II (D-0545-2026, reported May 27, 2026, ongoing)

Latest (original, serious recalls)

Recent recalls

Recently reported serious (Class I/II) recalls (original). Each is based on official primary information.

Class I Wawa Fruit Punch Pint (16oz), Plastic bottle Food ・ Wawa Beverage Company ・ 2026/06/03
Class I Wawa Iced Tea Lemon 16 oz Pint, Plastic bottle Food ・ Wawa Beverage Company ・ 2026/06/03
Class I Parmesan & Herb Bagel Crisps, Item Number 18139, Net Weight: 10 lbs. Legacy Ba... Food ・ Legacy Bakehouse LLC ・ 2026/06/03
Class I giant eagle Baked Pita Chips with Parmesan, Garlic & Herb Bagel Crisps, Net Wt... Food ・ Legacy Bakehouse LLC ・ 2026/06/03
Class I (BULK) SPL-BEV Banana CWT (Banana Smoothie); Super Sack Tote Item# 355-0099 Food ・ Honeyville, Inc ・ 2026/06/03
Class I Wawa Diet Lemonade Pint (16oz), Plastic bottle Food ・ Wawa Beverage Company ・ 2026/06/03
Class II Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimul... Medical Device ・ Medtronic Neuromodulation ・ 2026/06/03
Class II GE HealthCare CARESCAPE TELEMETRY SERVER V5 ATO MODEL, REF #2063702-101, Product... Medical Device ・ GE Medical Systems Information Technologies Inc ・ 2026/06/03
Class II GE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit - Orde... Medical Device ・ GE Medical Systems Information Technologies Inc ・ 2026/06/03
Class II GE HealthCare IOU ASSY ARK2250 CARESCAPE TELEMETRY SERVER, REF #2108729-901, Pro... Medical Device ・ GE Medical Systems Information Technologies Inc ・ 2026/06/03
Class I Automated Impella Controller (AIC); Product Code: 0042-0000-US; Medical Device ・ Abiomed, Inc. ・ 2026/06/03
Class II HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3 Medical Device ・ Devicor Medical Products Inc ・ 2026/06/03
Class II Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003... Medical Device ・ PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ・ 2026/06/03
Class II GE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603... Medical Device ・ GE Medical Systems Information Technologies Inc ・ 2026/06/03
Class II Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS),... Medical Device ・ O&M HALYARD INC ・ 2026/06/03
Class II Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063,... Medical Device ・ PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ・ 2026/06/03
Class II Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimul... Medical Device ・ Medtronic Neuromodulation ・ 2026/06/03
Class I Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, la... Medical Device ・ Medline Industries, LP ・ 2026/06/03
Class I RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-3... Medical Device ・ Bolton Medical Inc. ・ 2026/06/03
Class I Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, la... Medical Device ・ Medline Industries, LP ・ 2026/06/03
Class II Medline medical convenience kit labeled as EYE TRAY-LF, Medline Kit SKU DYNJ2162... Medical Device ・ Medline Industries, LP ・ 2026/06/03
Class I Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, la... Medical Device ・ Medline Industries, LP ・ 2026/06/03
Class I Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, la... Medical Device ・ Medline Industries, LP ・ 2026/06/03
Class I Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, la... Medical Device ・ Medline Industries, LP ・ 2026/06/03
Class II GE HealthCare ApexPro v6.0 eDelivery Software, REF #5700026, Product Code SUV; u... Medical Device ・ GE Medical Systems Information Technologies Inc ・ 2026/06/03
Class I Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, la... Medical Device ・ Medline Industries, LP ・ 2026/06/03
Class I Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, la... Medical Device ・ Medline Industries, LP ・ 2026/06/03
Class II GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF... Medical Device ・ GE Medical Systems Information Technologies Inc ・ 2026/06/03
Class II Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are pac... Drug ・ Safecor Health, LLC ・ 2026/05/27
Class I GHIRARDELLI PREMIUM HOT COCOA MIX NET WT 32oz (2lbs) 907g Ingredients: *** nonfa... Food ・ Ghirardelli Chocolate Company ・ 2026/05/27

Source: openFDA (U.S. FDA, CC0 public domain). Data is provided as-is and must not be used for medical decisions. Verify the latest and exact details with the official FDA recall information. This site is not endorsed or certified by the U.S. FDA.