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 Burette Sets Due to Backflow Risk

B Braun Medical recalled 12,320 burette sets on October 29, 2025, due to a risk of medication backflow. This defect can lead to serious health risks for patients. The recall affects devices distributed worldwide, including the U.S., Canada, Germany, Guatemala, and Singapore.

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HIGHFDA DEVICE

B Braun Medical Recalls IV Administration Set Due to Backflow Risk

B Braun Medical recalled nearly 19,000 IV administration sets on October 29, 2025, due to a serious backflow risk. The affected products may allow medication to flow back from secondary containers into primary ones. This poses significant health risks to patients.

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HIGHFDA DEVICE

B Braun Medical Recalls IV Administration Sets Over Backflow Risk

B Braun Medical issued a recall for 1,250 IV administration sets on October 29, 2025. The recall stems from a potential backflow of medication between IV containers, posing a serious risk to patients. Healthcare providers and patients must stop using the devices immediately.

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HIGHFDA DEVICE

B Braun Medical Recalls IV Administration Sets Over Backflow Risk

B Braun Medical recalled 381,850 IV administration sets on October 29, 2025. The recall addresses potential backflow of medication from secondary IV containers into primary containers. This issue poses a significant risk to patients and healthcare providers worldwide.

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HIGHFDA DEVICE

B Braun Medical Recalls IV Administration Sets Over Backflow Risk

B Braun Medical recalled over 12 million IV administration sets on October 29, 2025. The recall affects models sold worldwide, including the U.S., due to a potential backflow risk of medication. Users should stop using these devices immediately and follow manufacturer instructions.

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HIGHFDA DEVICE

B Braun Medical Recalls IV Administration Sets Over Backflow Risk

B Braun Medical recalled 46,250 IV administration sets on October 29, 2025. The recall follows concerns about potential backflow of medication into primary IV containers. The affected products were sold worldwide, including the US and Canada.

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HIGHFDA DEVICE

B Braun Medical Recalls IV Extension Sets Over Backflow Risk

B Braun Medical recalled 11,650 IV extension sets on October 29, 2025, due to potential backflow of medication. This defect affects the Infusomat Space, Outlook, and Vista Basic Pumps. Patients must stop using the device 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 Outlook IV administration sets on October 29, 2025, due to a potential backflow hazard. The affected products may allow medication to flow back from secondary containers into primary IV containers. This recall affects units distributed worldwide, including the U.S., Canada, Germany, Guatemala, and Singapore.

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HIGHFDA DEVICE

B Braun Medical Recalls IV Administration Set Over Backflow Risk

B Braun Medical recalled approximately 259,392 IV Administration Sets on October 29, 2025, due to a risk of medication backflow. The recall affects products with catalog number 490309 distributed 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 98,568 IV administration sets on October 29, 2025. The recall affects sets labeled as Catalog Number 490274 due to a risk of medication backflow. Healthcare providers and patients should stop using these devices immediately.

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HIGHFDA DEVICE

B Braun Medical Recalls Anesthesia IV Sets Over Backflow Risk

B Braun Medical recalled 58,752 Anesthesia IV Sets on October 29, 2025. The recall follows reports of potential backflow of medication from secondary IV containers. This poses a high hazard level for patients using the Infusomat Space and other pumps.

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