Olympus Corporation of the Americas recalls 1,276 boxes of MAJ-1218 Single Use Biopsy Valve distributed nationwide to healthcare facilities. The device risks rubber fragment detachment during use. Stop using the device and follow the recall instructions from Olympus or your healthcare provider.
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-1218 is a single-use biopsy valve designed to attach to the instrument channel port of compatible endoscopes to prevent leakage of body fluids.
Rubber fragments detaching during use could contaminate the procedural field or injure the patient, requiring medical evaluation.
This recall is not described as part of a broader industry pattern in the notice.
Healthcare facilities using MAJ-1218 valves may need to quarantine affected inventory and follow recall procedures, potentially impacting procedural workflows and supply chains.
UDI-DI on box labeling and packaging; recall notice URL.
Refunds or replacements processed after a recall, typically within weeks as directed by Olympus.
Retain recall notice, packaging, lot numbers, and correspondence with Olympus for records.
Model/Catalog Number: MAJ-1218. UDI-DI: 14953170154291. 20 units per box. Quantity recalled: 1,276 boxes. Distribution: US Nationwide. All lot numbers affected. Intended use: Attached to the instrument channel port of compatible endoscopes to prevent leakage of body fluids.
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