FDA-Device2026-03-11Class IIPROCESSING DEFECT
Olympus Single Use Biopsy Valve MAJ-1218 recalled for rubber fragment detachment risk
What this means
Olympus has recalled its Single Use Biopsy Valve (model MAJ-1218) used during endoscopy procedures. Small rubber fragments may detach from the valve during use, potentially entering the patient's body. No injuries have been reported, but the risk prompted this recall of about 25,500 affected valves.
- Stop using MAJ-1218 biopsy valves immediately if your facility has them in stock.
- Check your inventory for affected lot numbers (all lots are included in this recall).
- Contact your Olympus representative or distributor for instructions on returning or replacing the valves.
- Review patient records if these valves were used and consult your facility's medical director if necessary.
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
1,276 boxes (20 units per box)
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1489-2026More Olympus recalls
- FDA-Device2026-07-29Olympus OEV321UH 4K UHD LCD Monitor recalled for faulty HDMI and DisplayPort connectors
- 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
Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.