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

2,251 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
Recalled Outdoor Master children's helmet - model OM-TD BIKE
HIGH
CPSC

Outdoor Master Helmets Recalled for Head Injury Risk

Outdoor Master recalled two models of children's and youth helmets on November 26, 2025. The helmets violate mandatory safety standards and pose a risk of serious head injury. Consumers should stop using them immediately and seek refunds.

Outdoor Master Children's and Youth Helmets
The recalled
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HIGHFDA DEVICE

Medline Recalls Homecare Beds Over Fire Hazard

Medline Industries recalled 22,565 Full Electric Low Basic Homecare Beds on November 26, 2025, due to a fire risk. The recall affects beds labeled with REF MDR107003ELO following 58 reports of overheating hand control pendants. Consumers should stop using the beds and follow recall instructions immediately.

Medline Industries, LP
Medline Industries
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HIGHFDA DEVICE

Medline Recalls Homecare Beds Over Fire Hazard Risk

Medline Industries recalled 373,392 homecare beds on November 26, 2025, due to a fire hazard. The hand control pendant can overheat, causing sparking or burning. The recall affects models MDR107002E and MDR107002E-4 sold in the U.S. and Canada.

Medline Industries, LP
Medline Industries
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HIGHFDA DEVICE

Cook Medical Recalls Introducer Sheaths Over Manufacturing Errors

Cook Medical recalled 7,952 Flexor Check-Flo introducers and sets on November 26, 2025. The devices may have been manufactured out of specification, potentially posing serious risks to patients. Health care providers and patients should stop using these products immediately.

Cook
Cook Medical
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HIGHFDA DEVICE

Cook Medical Recalls Transjugular Liver Access Set Over Hazardous Manufacturing

Cook Medical recalled 23 units of its Transjugular Liver Access Sets on November 26, 2025. The recall follows concerns that products may have been manufactured out of specification, leading to potential use errors. Healthcare providers and patients should stop using the device immediately and follow recall instructions.

Cook
Cook Medical
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HIGHFDA DEVICE

Medline Recalls IV Administration Sets Due to Valve Malfunction

Medline Industries recalled 12 IV administration kits on November 26, 2025. The kits may contain defective check valve components that can become stuck. Patients and healthcare providers should stop using these devices immediately.

Medline Industries, LP
Medline kits
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HIGHFDA DEVICE

Medline Recalls IV Administration Sets Over Valve Malfunction Risk

Medline Industries recalled 96 IV administration sets on November 26, 2025, due to a defect in the check valve. The defect can cause the valves to become stuck, posing a high risk for patients. Users should stop using the products immediately and follow the recall instructions.

Medline Industries, LP
Medline kits
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HIGHFDA DEVICE

Beckman Coulter Recalls 6,457 Immunoassay Analyzers Over Restart Issues

Beckman Coulter recalled 6,457 UniCel Dxl 800 analyzers on November 26, 2025, due to potential restart failures. The defect prevents the devices from transitioning to Ready mode, delaying patient sample processing. Healthcare providers must stop using the devices immediately and follow recall instructions.

Beckman Coulter
Beckman Coulter
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HIGHFDA DEVICE

Medline Recalls IV Administration Kits Over Valve Malfunction Risk

Medline Industries recalled 11,173 IV administration kits on November 26, 2025. The kits contain B. Braun IV Administration Sets and Pump Administration Sets with faulty check valves. These valves may become stuck, posing a high hazard to patients.

Medline Industries, LP
Medline kits
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HIGHFDA DEVICE

Medline Recalls IV Administration Sets Due to Valve Issues

Medline Industries recalled 3,045 IV administration kits on November 26, 2025. The recall affects several Medline kits due to potential malfunction of check valve components. Patients and healthcare providers should stop using these devices immediately.

Medline Industries, LP
Medline kits
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HIGHFDA DEVICE

Medline Recalls IV Administration Sets Over Stuck Valve Hazard

Medline Industries recalled 16 units of IV Administration Sets on November 26, 2025. Customers reported check valve components may become stuck, posing a risk during use. Healthcare providers should stop using these devices immediately and follow recall instructions.

Medline Industries, LP
Medline kits
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HIGHFDA DEVICE

Medline Recalls IV Administration Sets Due to Valve Issues

Medline Industries recalled 5,314 IV Administration Sets on November 26, 2025. The recall affects several product SKUs due to potential failure of check valve components. Patients and healthcare providers should stop using these devices immediately.

Medline Industries, LP
Medline kits
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HIGHFDA DRUG

Taro Pharmaceuticals Recalls Clindamycin Phosphate Over Impurities

Taro Pharmaceuticals recalled Clindamycin Phosphate USP, 1% topical solution on November 26, 2025. The recall affects specific lots due to failed impurity testing. Consumers should stop using the product immediately and consult healthcare providers.

CLINDAMYCIN PHOSPHATE
Failed Impurities/Degradation:
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HIGHFDA DEVICE

Medline Recalls IV Administration Sets Due to Sticking Valves

Medline Industries recalled 33 units of IV Administration Sets on November 26, 2025. The recall follows customer complaints about check valve components potentially becoming stuck. This defect poses a high risk to patient safety and requires immediate action from healthcare providers.

Medline Industries, LP
Medline kits
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HIGHFDA DEVICE

Medline Recalls IV Administration Sets Over Hazardous Check Valves

Medline Industries recalled 633 units of IV administration sets on November 26, 2025. The recall follows complaints that check valve components may become stuck, posing a high risk to patient safety. Healthcare providers and patients must stop using affected products immediately.

Medline Industries, LP
Medline kits
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HIGHFDA DEVICE

Medline Recalls IV Administration Sets Over High Hazard Risk

Medline Industries recalled 338 IV Administration Sets on November 26, 2025. The recall stems from complaints about malfunctioning check valve components. Patients and healthcare providers must stop using these devices immediately.

Medline Industries, LP
Medline kits
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HIGHFDA DEVICE

Medline Recalls Homecare Beds Over Fire Risk from Hand Control

Medline Industries recalled 35,694 Full Electric Lightweight Homecare Beds on November 26, 2025, due to a fire hazard. The hand control pendant may overheat under certain conditions, leading to potential fire risks. The company received 58 complaints related to sparking and burning incidents.

Medline Industries, LP
Medline Industries
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HIGHFDA DEVICE

Medline Recalls Electric Homecare Beds Due to Fire Hazard

Medline Industries recalled 138,412 electric homecare beds on November 26, 2025. Hazardous hand control pendants may overheat and pose a fire risk. The recall follows 58 reports of sparking, burning, and smoking incidents.

Medline Industries, LP
Medline Industries
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