These recalls involve products that pose serious risks of injury or death. Check if you own any of these products and take immediate action if needed.

High Risk Recalls

2,247 critical product recalls that require immediate attention. These products have been identified as posing serious safety hazards.

What to do if you own a recalled product:

  1. Stop using the product immediately
  2. Keep the product away from children
  3. Follow the remedy instructions provided
  4. Contact the manufacturer for a refund or replacement
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 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 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 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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HIGHFDA DEVICE

FUJIFILM Healthcare Recalls X-ray Tube Support Over Breakage Risk

FUJIFILM Healthcare Americas recalled 16 units of the CH-200 X-ray tube support on September 15, 2025, due to a potential shaft failure. The broken shaft could render protective components ineffective, posing a high risk during operation. Healthcare providers and patients must stop using the device immediately.

FUJIFILM Healthcare
It was
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HIGHFDA DEVICE

Alcon Recalls CONSTELLATION Devices Over High Hazard Risk

Alcon Research LLC recalled 28,323 CONSTELLATION ULTRAVIT and HYPERVIT devices on September 15, 2025, due to a high hazard risk. The recall affects products distributed worldwide, including multiple states in the U.S. and several countries.

Alcon Research
XXX
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