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

2,324 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

Medicrea Recalls IB3D PL Instruments Set Over Safety Hazard

Medicrea recalled 44 units of its IB3D PL Instruments Set on October 29, 2025. The orthopedic rotation tool handle may untread from the shaft, causing it to fail during use. Healthcare providers and patients must stop using the device immediately.

Medicrea
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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.

B Braun Medical
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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.

B Braun Medical
Potential for
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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.

B Braun Medical
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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.

B Braun Medical
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HIGHFDA DEVICE

B Braun Medical Recalls Anesthesia IV Sets Due to Backflow Risk

B Braun Medical recalled 19,320 Anesthesia IV Sets on October 29, 2025. The recall follows reports of potential backflow of medication from secondary IV containers. Patients and healthcare providers must stop using the device immediately.

B Braun Medical
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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.

B Braun Medical
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HIGHFDA DEVICE

B Braun Medical Recalls IV Administration Sets for Backflow Risk

B Braun Medical recalled 122,232 IV administration sets on October 29, 2025. The recall addresses potential backflow of medication from secondary IV containers into primary containers. Affected units were distributed worldwide including the US, Canada, Germany, Guatemala, and Singapore.

B Braun Medical
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HIGHFDA DEVICE

B Braun Medical Recalls IV Administration Sets Due to Backflow Risk

B Braun Medical recalled 3,120 IV administration sets on October 29, 2025, due to a risk of medication backflow. The recall affects models used with Infusomat Space, Outlook, and Vista Basic Pumps. The company advises patients and healthcare providers to stop using the devices immediately.

B Braun Medical
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HIGHFDA DEVICE

B Braun Medical Recalls IV Administration Set Over Backflow Risk

B Braun Medical recalled 45,288 IV administration sets on October 29, 2025. The recall addresses a risk of backflow from secondary IV containers into primary containers. Users must stop using the product immediately and follow manufacturer instructions.

B Braun Medical
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