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

1,498 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

B Braun Medical Recalls Anesthesia Tray Over Connector Hazard

B Braun Medical recalled 2,840 anesthesia trays on September 18, 2025. The recall stems from a potential defect in the catheter connector lid position. The product poses a high hazard risk to patients and healthcare providers.

B BRAUN MEDICAL
Potential for
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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
Firm has
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HeartSine Recalls Defibrillator Pads Over Electrical Contact Issues

HeartSine Technologies recalled over 1.2 million defibrillator pads on September 18, 2025. The recall affects several models due to defective pins that may disrupt electrical contact. Consumers and healthcare providers should stop using these pads immediately.

HeartSine Technologies
Due to
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HIGHFDA FOOD

Taproom Gourmet Recalls 15lb Bulk "Madison" Mix Over Allergen Risk

Taproom Gourmet recalled 3,547 cases of its 15lb bulk "Madison" Mix on September 18, 2025. The product lacks a proper ingredient label and contains undeclared allergens including peanuts, almonds, wheat, and soy. Consumers should stop using the product immediately and seek a refund.

Taproom Gourmet
No ingredient
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Taproom Gourmet Snack Mix Recalled Due to Allergen Risks

Taproom Gourmet recalled 3,547 cases of its "Fifth Avenue" Mix on September 18, 2025. The product lacks an ingredient label and contains undeclared allergens including peanuts, almonds, cashew, and soy. Consumers in NY, NJ, CT, CA, IL, and FL are urged to avoid consumption.

Taproom Gourmet
No ingredient
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Taproom Gourmet Recalls Bulk "Empire" Mix Over Allergen Risk

Taproom Gourmet recalled 3,547 cases of its 18lb bulk "Empire" Mix on September 18, 2025. The mix lacks an ingredient label and contains undeclared allergens including cashews and almonds. Consumers should not consume the product and seek a refund or replacement.

Taproom Gourmet
No ingredient
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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
Firm has
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Kirkland Signature Ahi Tuna Poke Recalled Over Listeria Risk

Kirkland Signature recalled 3,314.7 lbs of Ahi Tuna Wasabi Poke due to potential Listeria contamination. The recall was initiated on September 18, 2025. Consumers should not consume the product and seek refunds immediately.

Kirkland Signature
Listeria monocytogenes.
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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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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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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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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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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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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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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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