Olympus biopsy valve MAJ-1218 may shed rubber fragments during use
Olympus is recalling all lots of its Single Use Biopsy Valve, model MAJ-1218, because of the potential for rubber fragment detachment during use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: fragments may detach from a device attached to an endoscope during a procedure, and no injuries are stated in the source.
Plain-English summary
Olympus Corporation of the Americas is recalling the Olympus Single Use Biopsy Valve, model MAJ-1218, supplied 20 units per box. The valve is designed to be attached to the instrument channel port of compatible endoscopes to prevent leakage of body fluids. About 1,276 boxes were distributed nationwide in the United States. The FDA has classified this recall as Class II.
There is potential for rubber fragment detachment during use.
All lot numbers are affected. The product carries UDI-DI 14953170154291.
Facilities can identify affected valves by the model number and UDI above, and may contact Olympus Corporation of the Americas for further information.
The recalled product
- Product
- Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. The MAJ-1218 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent leakage of body fluids.
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Endoscopy
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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