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.

This page is a general organization of U.S. public information and is not medical advice or diagnosis. Data is provided as-is and may contain errors. Base health and safety decisions on official information and professionals.

Browse all collected data (list, filter, search) →

Featured

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

Class I (most serious) Medical Device Jul 22, 2026

FDA Class I recall: leakage risk in the introducer supplied with every Impella heart pump set (Abiomed)

The U.S. FDA classified Abiomed's Impella CP pump sets as a Class I recall, its most serious category, citing a potential for leakage from the introducer sheath that is supplied with the pump. The recall covers 87,277 units distributed worldwide.

The FDA classified it Class I, its most serious category (Z-2682-2026, reported July 22, 2026, status ongoing).
The recall covers the ABIOMED Impella CP Set (pump set code 0048-0003) with its 14 Fr introducer (product code 0052-3046) — 87,277 units.
The defect is potential leakage from under the sheath cap and along the hub score lines in 14 Fr and 23 Fr introducers.

Class I (most serious) Food Jul 22, 2026

FDA Class I recall: organic frozen blueberries from Chile over potential E. coli O145:H28

The U.S. FDA classified organic frozen whole blueberries shipped by Chile-based Frutas y Hortalizas del Sur S.A. as a Class I recall, its most serious category, citing potential contamination with E. coli O145:H28. The recall covers 3,640 cases distributed in Florida.

The FDA classified it Class I, its most serious category (H-1181-2026, reported July 22, 2026, status ongoing).
The recall covers organic frozen whole blueberries in 10 oz bags (8 bags per case), 3,640 cases; lot 6040 01, best by February 9, 2028.
The stated reason is potential E. coli O145:H28 contamination; O145 is a leading non-O157 Shiga toxin-producing (STEC) serotype.

Class I (most serious) Food Jul 15, 2026

FDA Class I recall: undeclared peanut in chocolate covered raisins caused by mis-packaging (Lehi Valley Trading)

The U.S. FDA classified High Valley Orchard Chocolate Covered Raisins, distributed by Lehi Valley Trading Company, as a Class I recall, its most serious category, because mis-packaging left undeclared peanut in the product. The recall covers 624 containers (585 pounds) distributed in Arizona, Nevada, New Mexico and Texas.

The FDA classified it Class I, its most serious category (H-1150-2026, reported July 15, 2026, status ongoing).
The recall covers 624 High Valley Orchard Chocolate Covered Raisins 15 oz containers (585 lb total), lot 0160933, best by January 23, 2027.
The stated reason is undeclared peanut resulting from mis-packaging; the label declares milk and soy.

Class I (most serious) Medical Device Jul 8, 2026

FDA Class I recall: air and medication leaking from the nebulizer cup on VOLARA respiratory therapy circuits (Baxter)

The U.S. FDA classified Baxter's single-patient-use circuits for the Hillrom VOLARA system as a Class I recall, its most serious category, following reports of air and medication leaking from the nebulizer cup during therapy. The recall covers 13,881 units distributed in the United States and Canada.

The FDA classified it Class I, its most serious category (Z-2551-2026, reported July 8, 2026, status ongoing).
The recall covers 13,881 Hillrom VOLARA System P.CIRCUIT 5KIT AC units (REF M08474), distributed in the United States and Canada.
Air and medication have been reported leaking from the nebulizer cup during therapy, which can lower the patient's oxygen level and cause ineffective nebulization.

Class I (most serious) Medical Device Jul 8, 2026

FDA Class I recall: potential distal tip detachment in the Harmony delivery catheter, distributed worldwide including Japan (Medtronic)

The U.S. FDA classified the Medtronic Harmony Delivery Catheter System as a Class I recall, its most serious category, because devices built with inner shaft assemblies from specific manufacturing lots may have an increased potential for distal tip detachment. The recall covers 1,881 units distributed worldwide, including Japan.

The FDA classified it Class I, its most serious category (Z-2624-2026, reported July 8, 2026, status ongoing).
The recall covers 1,881 units of the Medtronic Harmony Delivery Catheter System (GTIN 00763000341367; affected lots listed in the record).
The defect is an increased potential for distal tip detachment in devices with inner shaft assemblies from specific manufacturing lots.

Class I (most serious) Medical Device Jul 8, 2026

FDA Class I recall: Omnipod (Eros) Pod cannula damage causes insulin to leak and under-deliver (Insulet)

The U.S. FDA classified Insulet's tubeless insulin pump, the Omnipod (Eros) Pod, as a Class I recall, its most serious category, after external soft cannula damage during manufacturing was found to let insulin leak around the Pod instead of reaching the user. The recall covers 289,046 units distributed in the United States and 20 other countries.

The FDA classified it Class I, its most serious category (Z-2605-2026, reported July 8, 2026, status ongoing).
The recall covers 289,046 Omnipod (Eros) Pods, including model/REF numbers POD-ZXP425/420, ZXR425/420 and ZXP425/420.
The cause is external soft cannula damage during manufacturing, letting insulin leak around the Pod for both basal and bolus delivery.

Class I (most serious) Food Jul 8, 2026

FDA Class I recall: moringa supplement capsules over potential Salmonella, sold nationwide via Amazon and other marketplaces (MOGO Moringa)

The U.S. FDA classified MOGO Moringa's pure moringa oleifera capsules as a Class I recall, its most serious category, because the product may be contaminated with Salmonella Typhimurium. The recall covers 23,186 bottles sold nationwide through Amazon, eBay, Etsy and the company website.

The FDA classified it Class I, its most serious category (H-1128-2026, reported July 8, 2026, status ongoing).
The recall covers 23,186 bottles of MOGO PURE MORINGA OLEIFERA CAPSULES (180 capsules, 350 mg each); lots 15525AA and 00926AA.
The stated reason is potential contamination with Salmonella Typhimurium.

Class I (most serious) Food Jul 8, 2026

FDA Class I recall: infant formula that may be contaminated with Clostridium botulinum — 377,610 cans nationwide (nara organics)

The U.S. Food and Drug Administration (FDA) classified nara organics brand organic infant formula (milk-based powder with iron, for 0-12 months) as a Class I recall, its most serious category, because the product may be contaminated with Clostridium botulinum. The recall covers 377,610 cans distributed nationwide.

The FDA classified it Class I, its most serious category (H-1137-2026, reported July 8, 2026, status ongoing).
The products are nara organics brand organic infant formula (milk-based powder with iron, 0-12 months) in 24.7 oz and 14.1 oz cans.
The stated reason is that the product may be contaminated with Clostridium botulinum.

Class I (most serious) Medical Device Jun 3, 2026

FDA Class I recall: Medline procedure kits containing Huons bupivacaine pulled in chain recall

The FDA classified procedure kits distributed by Medline Industries as a Class I recall because the Huons bupivacaine injection packed inside them had itself been recalled over quality issues, including microbiology testing.

Classified as an FDA Class I recall (the most serious category); covers 270 procedure kits from Medline Industries, LP.
Root cause: the Huons Co. bupivacaine injection packed in the kits was recalled first over quality issues, including microbiology testing.
The problem lay in a single packed-in component, not the kit's own design or manufacture, and chained to the recall of the whole finished product.

Class I (most serious) Medical Device Jun 3, 2026

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) Medical Device Jun 3, 2026

FDA Class I recall: Bolton Medical RelayPro Thoracic Stent-Graft System labeling update over delivery-system release risk

The FDA has classified a Class I recall (recall_number: Z-2160-2026) of Bolton Medical's RelayPro Thoracic Stent-Graft System, involving a labeling update. The proximal clasp may disconnect from the outer control tube, which may prevent the stent graft from being released from the delivery system.

The affected device is Bolton Medical Inc.'s RelayPro Thoracic Stent-Graft System (various sizes).
The reason is a labeling update concerning proximal clasp disconnection from the outer control tube, which may prevent the stent graft from being released from the delivery system.
The FDA classification is the most serious, Class I (recall_number: Z-2160-2026).

Class I (most serious) Medical Device Jun 3, 2026

FDA Class I recall: Abiomed Automated Impella Controller (AIC) units requiring hardware updates

The U.S. Food and Drug Administration (FDA) classified a recall of Abiomed's Automated Impella Controller (AIC) as Class I, its most serious category. A retrospective review identified AIC units that require specific hardware updates to address potential safety concerns.

On June 3, 2026, the FDA classified a recall of Abiomed's Automated Impella Controller (AIC, product code 0042-0000-US) as Class I, its most serious category.
Impella is a circulatory support device that temporarily assists the heart's pumping function, and the AIC is the controller that operates it.
The reason is that a retrospective review identified AIC units requiring specific hardware updates to address potential safety concerns.

Class I (most serious) Food Jun 3, 2026

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 Jun 3, 2026

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) Food Jun 3, 2026

FDA Class I recall: bulk banana smoothie ingredient pulled over possible Salmonella (Honeyville)

Honeyville, Inc. is recalling a bulk, business-use banana smoothie ingredient because the firm received and used a potentially Salmonella-contaminated ingredient to manufacture various products. The FDA classified it as Class I, its most serious category.

A food recall classified as Class I, the highest of the FDA's three severity tiers for recalls.
The product is a bulk, business-use banana smoothie ingredient ((BULK) SPL-BEV Banana CWT, Super Sack Tote).
The reason on record: the firm received and used a potentially Salmonella-contaminated ingredient to manufacture various products.

Class I (most serious) Food Jun 3, 2026

FDA Class I recall: Giant Eagle pita chips made with Salmonella-recalled milk powder (Legacy Bakehouse)

On June 3, 2026, the U.S. FDA reported a Class I recall — its most serious category — for Giant Eagle-brand pita chips made by Legacy Bakehouse LLC, because they were produced with milk powder from California Dairies that had already been recalled for Salmonella.

On June 3, 2026, the FDA reported this recall in its most serious Class I tier (status: Ongoing).
The product is "giant eagle Baked Pita Chips with Parmesan, Garlic & Herb Bagel Crisps, 7.33 oz," totaling 224 cases (12 bags of 7.33 oz).
The recall reason is the use of California Dairies milk powder that had been recalled for Salmonella.

Class I (most serious) Food Jun 3, 2026

FDA Class I recall: Wawa lemon iced tea with undeclared milk allergen (H-0855-2026)

The U.S. FDA has announced a Class I recall, its most serious category, for a lemon-flavored iced tea (16 oz plastic bottle) made by Wawa Beverage Company because it contains milk that is not declared on the label.

Classified as Class I, the most serious recall tier (used when serious health harm is possible).
The product is Wawa Beverage Company's lemon iced tea, 16 oz plastic bottle.
The reason is an undeclared milk allergen (milk content not shown on the label).

Class I (most serious) Drug May 27, 2026

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