FDA-Device2026-03-11Class IIPROCESSING DEFECT
Olympus MAJ-210 single-use biopsy valve recalled for rubber fragment detachment risk
What this means
Olympus has recalled the MAJ-210 single-use biopsy valve (a device that attaches to endoscopes to prevent fluid backflow) because rubber fragments may detach during use. The recall affects all lot numbers of this product sold nationwide. No injuries have been reported to date.
- Stop using MAJ-210 biopsy valves immediately
- Contact your facility's medical device or procurement department with the lot number
- Do not use affected units on patients
- Return unused units to Olympus or your supplier
The agency's original wording
Hazard
Potential for rubber fragment detachment during use.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
95,882 boxes (20 per box)
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The MAJ-210 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent reflux of body fluids.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1488-2026More Olympus recalls
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- FDA-Device2026-07-29Olympus High Flow Insufflation Unit UHI-4 recalled for unexpected display shutdown and air delivery loss
- FDA-Device2026-07-22Olympus Toomey Evacuator 50cc Model 188A recalled for inadequate sterilization parameters
- FDA-Device2026-07-22Olympus Glass Body for 194 Ellik Evacuator recalled for inadequate sterilization
- FDA-Device2026-07-22Olympus Toomey Evacuator 30cc with Adaptor recalled for inadequate sterilization
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