All Product Recalls

Browse through 2,313 product recalls and safety alerts. Filter by hazard level, status, or search for specific products.

HIGHFDA DEVICE

Cardinal Health Recalls Anti-Reflux Valves Over Breakage Risk

Cardinal Health 200 recalled all lots of its Anti-Reflux Valves on September 18, 2025, after reports of breakage due to excessive force. The recall affects products distributed worldwide, including in the U.S. Consumers must stop using the valves immediately and follow manufacturer guidance.

Cardinal Health 200
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HIGHFDA DEVICE

Cardinal Health Recalls PVC Tubes Over Valve Breakage Risk

Cardinal Health 200 recalled its Salem Sump PVC tubes on September 18, 2025, due to reports of Anti-Reflux Valve (ARV) breakage. Excessive force during use caused the failures, posing a high hazard to patients. The recall affects all lots distributed worldwide.

Cardinal Health 200
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HIGHFDA DEVICE

Cardinal Health Recalls Salem Sump Tubes Over Valve Breakage Risk

Cardinal Health 200 recalled Salem Sump silicone dual lumen stomach tubes on September 18, 2025. The recall affects all lots due to complaints of Anti-Reflux Valve breakage during use. Patients and healthcare providers should stop using the devices immediately.

Cardinal Health 200
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HIGHFDA DEVICE

Cardinal Health Recalls Salem Sump Tubes Over Valve Breakage Risk

Cardinal Health recalled all lots of Salem Sump stomach tubes on September 18, 2025. The recall affects tubes with product codes 264929, 264945, and others due to complaints of valve breakage. Patients and healthcare providers should stop using the devices immediately.

Cardinal Health 200
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HIGHFDA DEVICE

Cardinal Health Recalls Salem Sump PVC Tubes Due to Breakage Risk

Cardinal Health 200 recalled Salem Sump PVC gastroduodenal tubes on September 18, 2025. The recall affects all lots sold worldwide due to complaints of Anti-Reflux Valve breakage. Patients and healthcare providers must stop using the devices immediately.

Cardinal Health 200
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HIGHFDA DRUG

Glenmark Pharmaceuticals Recalls Azelaic Acid Gel Over Texture Issues

Glenmark Pharmaceuticals Inc. recalled 13,824 tubes of Azelaic Acid Gel on September 17, 2025. The recall stems from market complaints regarding a gritty texture. Consumers should stop using the product immediately and contact their healthcare provider.

Glenmark Pharmaceuticals
CGMP Deviations:
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HIGHFDA FOOD

D & M Smoked Fish Recalls Cold Smoked Salmon Over Listeria Risk

D & M Smoked Fish, Inc. recalled 2,022 pieces of Haifa Cold Smoked Salmon on September 17, 2025. The product is contaminated with Listeria monocytogenes, which poses a serious health risk. Consumers in NY, NJ, PA, WA, CA, IL, and FL should not consume this product.

D & M Smoked Fish
Contaminated with
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HIGHFDA DEVICE

Baxter Healthcare Recalls Oral Probes Over Temperature Misreadings

Baxter Healthcare recalled 5,209 oral probes on September 17, 2025. The probes were incorrectly programmed to show lower temperatures, risking delayed treatment for fever-related symptoms. Consumers and healthcare providers must stop using the affected probes immediately.

Baxter Healthcare
Affected oral/axillary
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HIGHFDA DRUG

Park Avenue Compounding Phenylephrine HCI Syringes Recalled Over CGMP Violations

Park Avenue Compounding recalled 858 syringes of Phenylephrine HCI on September 17, 2025, due to CGMP deviations. The recall affects syringes with Lot # 20250813-13D65E and an expiration date of February 9, 2026. Consumers must stop using the product immediately and consult healthcare providers for further guidance.

Park Avenue Compounding
CGMP Deviations
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HIGHFDA DEVICE

Enterix Recalls InSure ONE Test Kits Due to False Negative Risk

Enterix recalled 201,426 InSure ONE fecal immunochemical test kits on September 17, 2025. The kits may produce false negative results due to failed sensitivity testing with Test Card Lot T241102. The recall affects units distributed worldwide, including multiple states in the U.S.

Enterix
InSure ONE
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HIGHFDA DEVICE

Percussionaire Recalls In-Line Valve Due to Leak Hazard

Percussionaire recalled 59,160 Phasitron 5 In-Line Valves on September 17, 2025. The valves may leak when used with ventilators, posing a high risk of respiratory failure. Consumers should stop using the product immediately and follow recall instructions.

Percussionaire
IFU update;
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HIGHFDA FOOD

D & M Smoked Fish Recalls Cold Smoked Seabass Over Listeria Risk

D & M Smoked Fish, Inc. recalled 348 pieces of Cold Smoked Seabass on September 17, 2025. The product may contain Listeria monocytogenes, a serious health risk. Consumers in NY, NJ, PA, WA, CA, IL, and FL should not consume this product.

D & M Smoked Fish
Contaminated with
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HIGHFDA FOOD

Sprout Organics Baby Food Recalled Over Lead Contamination Risk

Sprout Foods, Inc. recalled 9,873 cases of its 6+ Months Organic Baby Food on September 16, 2025. The recall stems from potential contamination with lead, a heavy metal. The affected products include several lot numbers with best by dates ranging from October 29, 2025, to February 4, 2026.

Sprout Organics
Potential contamination
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