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 IV Administration Sets Due to Backflow Risk

B Braun Medical recalled 48 IV Administration Sets on October 29, 2025, after reports of potential medication backflow. The affected sets are used with the Infusomat Space, Outlook, and Vista Basic Pumps. Healthcare providers must stop using the devices immediately and follow recall instructions.

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HIGHFDA DEVICE

B Braun Medical Recalls IV Administration Sets Over Backflow Risk

B Braun Medical recalled over 49 million IV administration sets on October 29, 2025. The recall addresses a potential backflow of medication from secondary IV containers into primary IV containers. Users should stop using the affected devices immediately.

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HIGHFDA DEVICE

B Braun Medical Recalls IV Administration Set Over Backflow Risk

B Braun Medical recalled 168,816 IV Administration Sets on October 29, 2025. The sets may allow backflow of medication from secondary containers into primary containers. This recall affects products sold worldwide, including the US, Canada, Germany, Guatemala, and Singapore.

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HIGHFDA DEVICE

B Braun Medical Recalls IV Administration Sets Over Backflow Risk

B Braun Medical recalled 9,500 IV administration sets on October 29, 2025, due to a risk of medication backflow. The recall affects models used in conjunction with the Infusomat Space, Outlook, and Vista Basic pumps. Healthcare providers and patients must stop using these devices immediately to avoid serious health risks.

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HIGHFDA DEVICE

B Braun Medical Recalls IV Administration Sets Over Medication Backflow Risk

B Braun Medical recalled 12,700 IV administration sets on October 29, 2025, due to a risk of medication backflow. The affected models include Catalog Number 352062, distributed worldwide including the US, Canada, and Germany. Healthcare providers must stop using these devices immediately.

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HIGHFDA DEVICE

B Braun Medical Recalls Blood Administration Sets Over Backflow Risk

B Braun Medical recalled 5,448 blood administration sets on October 29, 2025. The recall affects devices used with Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. The company cited potential backflow of medication and occlusion as the primary hazards.

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HIGHFDA DEVICE

B Braun Medical Recalls IV Administration Set Over Backflow Risk

B Braun Medical recalled 31,392 IV administration sets on October 29, 2025, due to a high risk of medication backflow. The affected models include catalog number 490301. This recall affects devices distributed worldwide, including the US and Canada.

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HIGHFDA DEVICE

B Braun Medical Recalls IV Administration Sets Over Backflow Risk

B Braun Medical recalled 4,536 IV administration sets on October 29, 2025. The recall affects devices that may allow backflow of medication from secondary IV containers. This poses a high risk to patients using the Infusomat Space, Outlook, and Vista Basic pumps.

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HIGHFDA DEVICE

B Braun Medical Recalls IV Administration Sets Over Backflow Risk

B Braun Medical recalled 1,861,111 IV administration sets on October 29, 2025. The recall addresses a significant risk of medication backflow from secondary IV containers into primary containers. Healthcare providers and patients must stop using the devices immediately.

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