All Product Recalls

Browse through 2,234 product recalls and safety alerts. Filter by hazard level, status, or search for specific products.

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

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

Olympus Recalls Electrosurgical Knife Over Burning Risk

Olympus Corporation of the Americas recalled the Single Use Electrosurgical Knife KD-640L on February 17, 2024. The recall follows reports of overheating and potential tip breakage during surgery. Healthcare providers and patients must stop using the device immediately to avoid injuries.

Olympus Corporation of the Americas
A deterioration
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HIGHFDA DEVICE

Olympus Recalls Electrosurgical Knife Over Burn Hazard

Olympus Corporation recalled 3,361 Single Use Electrosurgical Knives on February 17, 2024, due to burn risks from tip breakage. The recall affects model KD-645L, distributed nationwide. The defective knives may overheat and deteriorate during use, posing serious safety risks.

Olympus Corporation of the Americas
A deterioration
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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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