All Product Recalls

Browse through 1,551 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
Firm has
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HIGHFDA FOOD

Goyal Group Recalls Aluminium Cookware Due to Lead Hazard

Goyal Group recalled 293 sets of aluminium cookware on September 18, 2025. The products contain elevated levels of lead, posing a health risk. Consumers should stop using these items immediately and contact the company for a refund.

Goyal Group
Contains elevated
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HIGHFDA DEVICE

B Braun Medical Issues Recall for Epidural Anesthesia Tray Due to Connector Hazard

B Braun Medical recalled 2,760 units of its PERIFIX FX Continuous Epidural Anesthesia Tray on September 18, 2025. The recall stems from a potential misalignment of the catheter connector lid, posing a high risk to patients. Healthcare providers and patients must stop using the device immediately and follow the manufacturer’s instructions.

B BRAUN MEDICAL
Potential for
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HIGHFDA DEVICE

B BRAUN MEDICAL Recalls Epidural Anesthesia Set Over Connector Issue

B BRAUN MEDICAL recalled its PERIFIX FX Continuous Epidural Anesthesia Set on September 18, 2025. The recall affects a potential defect in the catheter connector lid position. This high-risk issue could impact patient safety in healthcare settings across the country.

B BRAUN MEDICAL
Potential for
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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
Firm has
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HIGHFDA DEVICE

GE Medical Systems Recalls Ultrasound Device Over Inaccurate Data

GE Medical Systems recalled 65 units of its LOGIQ P10 series ultrasound device on September 18, 2025. The device may show inaccurate liver steatosis measurements, risking inappropriate clinical decisions. Healthcare providers must cease use immediately and follow recall instructions.

GE Medical Systems
The Ultrasound-Guided
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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 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 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 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 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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HIGHFDA DRUG

IntegraDose Recalls Oxytocin Injection Due to No Active Ingredient

IntegraDose Compounding Services LLC recalled 853 bags of Oxytocin 30 Units/500 mL on September 16, 2025. Testing revealed these IV bags contain no oxytocin, posing serious health risks. The recall affects products distributed nationwide in the USA.

IntegraDose Compounding Services
Subpotent Drug:
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