Olympus Corporation of the Americas recalls 95,882 boxes of MAJ-210 single-use biopsy valves distributed nationwide to hospitals and clinics in the United States after reports of rubber fragments detaching during use. The defect can release fragments into the endoscope channel or patient. Healthcare facilities should stop using the device immediately and follow recall instructions.
Potential for rubber fragment detachment during use.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Olympus Corporation of the Americas or your healthcare provider for instructions. Notification method: Letter
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Model/Catalog Number: MAJ-210; UDI-DI: 14953170152433; Additional UDI: 14953170452069; 20 units per box; Quantity recalled: 95,882 boxes; Sold/distributed: US nationwide; Status: Active recall; Recall date: 2026-01-29; Remedy: Stop use and follow manufacturer recall instructions; Manufacturer: Olympus Corporation of the Americas.
Rubber fragments may detach during use. Detached fragments could enter the endoscope channel or patient during procedures.
1 Stop using the product immediately. 2 Contact Olympus Corporation of the Americas for instructions. 3 Follow recall instructions provided by Olympus. 4 Return or replace per instructions and pursue refunds as applicable. 5 Document communications and keep records of all steps.
Phone: Unknown. Website: https://www.olympus-global.com. Hours: Unknown. For official recall instructions, refer to the FDA notice and Olympus guidance.
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