FDA-Device2026-03-11Class IIPROCESSING DEFECT
Olympus MAJ-210 single-use biopsy valve recalled for rubber fragment detachment risk
OTHERNationwide distribution
Stop using Olympus MAJ-210 biopsy valves
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
Hazard
Potential for rubber fragment detachment during use.
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 Corporation of the Americas recalls
- FDA-Device2026-04-08Olympus SOLTIVE Premium laser system recalled for defective power supply
- FDA-Device2026-04-08Olympus SOLTIVE Pro SuperPulsed Laser System recalled for power supply defect
- FDA-Device2026-04-01Olympus PKS Cutting Forceps recalled for defective welds causing jaw breakage
- FDA-Device2026-04-01Olympus MAJ-1443 and MAJ-1444 endoscope suction valves no longer compatible with OER-Pro and OER-Elite reprocessors
- FDA-Device2026-04-01Olympus PKS Cutting Forceps recalled for defective welds causing jaw breakage
Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief