FDA recall, , Moderate risk
Olympus Single Use Biopsy Valve
The Olympus Single use Biopsy Valve can detach rubber fragments during use.
Summary by Recall Canary from the FDA notice
What happened
Olympus Corporation of the Americas, of Center Valley, Pennsylvania, recalled its Olympus Single use Biopsy Valve, models MAJ-210 and MAJ-1218, because of potential for rubber fragment detachment during use. The recall began January 29, 2026, and was added to the FDA's Enforcement Report on March 3, 2026. The products were distributed nationwide.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your box affected?
2 products
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
A UDI-DI is the device identifier printed with the barcode on the device label.
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.
- UDI-DI
- 14953170152433
- 14953170452069
- Lot code
- All Lot Numbers. 20 units per box.
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.
- UDI-DI
- 14953170154291
- Lot code
- All Lot Numbers. 20 units per box.
Recall details
- Company began the recall
- Sold in
US Nationwide distribution.
- Company
- Olympus Corporation of the AmericasCenter Valley, Pennsylvania
- Hazard
- Foreign object
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98240
- Recall numbers
- Z-1488-2026 to Z-1489-2026
All recalls from Olympus Corporation of the Americas
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
