445 recalls tagged with “burn risk”.
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.
Omnia Medical recalled 15 units of the TiBrid Stand Alone Intervertebral Body Fusion Device SA Angled Punch Awl. The recall covers models 17-5A-AWL3, 17-5A-AWL4, 17-5A-AWL5 with UDI 00843511113056 and 00843511122287/22294. The hazard is failure of fusion system instruments in the field. Consumers should stop use and follow recall instructions.
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 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.
Surepulse Medical recalled a component of its newborn heart rate monitor on January 20, 2023. The recall affects the VS Cap Medium REF: SP-161-A1 due to incorrect sizing information on the label. This issue poses a high risk to patients and healthcare providers using the device.