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

1,488 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

Intuitive Surgical Recalls da Vinci 5 Console Motor Connector Due to High Hazard

Intuitive Surgical recalled 144 units of the da Vinci 5 Surgeon Console Column Motor Connector on August 21, 2024. Users reported a potential ergonomic lock issue that could delay or abort surgical procedures. Healthcare providers must stop using the devices immediately and follow the recall instructions.

Intuitive Surgical
Surgical system
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HIGHFDA DEVICE

Omnia Medical Recalls Intervertebral Fusion Devices Over Hazard

Omnia Medical recalled 15 units of the TiBrid Stand Alone Intervertebral Body Fusion Device on July 15, 2024. The recall affects devices distributed nationwide across six states due to potential failure of fusion system instruments. Patients and healthcare providers must stop using the devices immediately to avoid high-risk complications.

Omnia Medical
Failure of
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HIGHFDA DEVICE

Omnia Medical Recalls Intervertebral Fusion Device Over Safety Hazard

Omnia Medical recalled 15 units of the TiBrid Stand Alone Intervertebral Body Fusion Device on July 15, 2024. The recall follows reports of failure of fusion system instruments in the field. Healthcare providers and patients must stop using the device immediately.

Omnia Medical
Failure of
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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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