immediate action Recalls

2,715 recalls tagged with “immediate action”.

Health & Personal Care
HIGH
FDA 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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Health & Personal Care
HIGH
FDA 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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Health & Personal Care
HIGH
FDA 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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Health & Personal Care
HIGH
FDA 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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Health & Personal Care
HIGH
FDA 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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Health & Personal Care
HIGH
FDA DEVICE

NOXBOX Recalls Nitric Oxide Delivery System Due to Pump Failures

NOXBOX recalled 1,667 Nitric Oxide Delivery Systems on July 19, 2023. The recall addresses high failure rates of the internal Sample Pump. Patients should stop using the device immediately and follow manufacturer instructions.

NOXBOX
Replacement of
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Health & Personal Care
HIGH
FDA 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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Health & Personal Care
HIGH
FDA 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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Health & Personal Care
HIGH
FDA DEVICE

Surepulse Medical Issues Recall for Newborn Heart Rate Monitor Component

Surepulse Medical recalled the VS Cap Small component of its newborn heart rate monitor on January 20, 2023. The recall stems from incorrect sizing information provided on the product label. This defect poses a significant risk to patient safety.

SUREPULSE MEDICAL
Retroactively reported;
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Health & Personal Care
HIGH
FDA 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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Health & Personal Care
HIGH
FDA 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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