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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The MAJ-210 is a single-use biopsy valve designed to attach to the instrument channel port of compatible endoscopes to prevent reflux of body fluids during procedures.
A rubber fragment can detach during use, creating a foreign-material risk inside the endoscope channel or patient.
This recall is not described as part of a broader industry pattern.
Hospitals and clinics may experience procedure delays while devices are quarantined. Replacements will require supplier coordination and processing time.
Refer to the FDA recall page and Olympus recall notifications for identifiers such as MAJ-210 and the UDI-DI codes
Refunds or replacements typically take 4-8 weeks after initiating the claim
Keep copies of recall notices, order records, shipment details, and all correspondence with Olympus
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.
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