burn risk Recalls

425 recalls tagged with “burn risk”.

Health & Personal Care
HIGH
FDA DEVICE

Olympus Cystoscope Outer Sheath Recalled Over Laser Incompatibility

Olympus Corporation of the Americas recalled 633 units of the Cystoscope Outer Sheath, Model WA22810A on September 13, 2024. The recall occurred due to potential device damage when used with a GreenLight Laser for BPH therapy. Healthcare providers and patients must stop using the device immediately and follow recall instructions.

Olympus Corporation of the Americas
Product being
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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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