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

2,168 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

Surepulse Medical Recalls Heart Rate Monitor Component Over Sizing Error

Surepulse Medical recalled its VS Cap Extra Small component of the VS Newborn Heart Rate Monitor on January 20, 2023. The recall affects devices distributed in the US and several other countries due to an incorrect sizing guide. Consumers must stop using the device immediately and follow manufacturer instructions.

SUREPULSE MEDICAL
Retroactively reported;
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HIGHFDA DEVICE

Surepulse Heart Rate Monitor Cap Recalled for Sizing Error

Surepulse Medical recalled the Extra Large VS Cap component of its newborn heart rate monitor on January 20, 2023. The recall followed reports of incorrect sizing information that could impact device use. This recall affects distribution in the U.S., the U.K., the Netherlands, and the United Arab Emirates.

SUREPULSE MEDICAL
Retroactively reported;
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HIGHFDA DEVICE

Surepulse Medical Recalls Heart Rate Monitor Component Over Sizing Error

Surepulse Medical recalled its VS Cap Large component for the newborn heart rate monitor on January 20, 2023. The recall addresses an incorrect sizing guide that could affect patient safety. This recall impacts distribution in the US and several countries including the UK and UAE.

SUREPULSE MEDICAL
Retroactively reported;
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HIGHFDA DEVICE

Foundation Medicine Recalls Companion Diagnostic Over Missing Claims Page

Foundation Medicine recalled 59 units of its FoundationOne CDx (F1CDx), RAL-0003 version 31.0 on November 8, 2022. The recall affects devices distributed in the U.S. and internationally due to missing important diagnostic information. Patients and healthcare providers must stop using the device immediately and follow manufacturer instructions.

Foundation Medicine
Reports were
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