FDA-Device2026-03-11Class IIPROCESSING DEFECT

Olympus Single Use Biopsy Valve MAJ-1218 recalled for rubber fragment detachment risk

OTHERNationwide distribution

Stop using Olympus MAJ-1218 biopsy valves

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.
Hazard

Potential for rubber fragment detachment during use.

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-1489-2026

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