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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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.
The recall cites a potential for rubber fragment detachment during use. If fragments detach, they could enter the patient during endoscopic procedures.
1. Stop using the device immediately. 2. Refer to the recall instructions from Olympus Corporation of the Americas. 3. Contact Olympus or your healthcare provider for further guidance.
Notification method: Letter. Website: the enforcement report page linked in the recall. Manufacturer: Olympus Corporation of the Americas.
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