Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. ... recall (Olympus Corporation of the Americas)
Medical deviceClass IIOngoing
Summary: Olympus Corporation of the Americas is recalling 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.. Reason: Potential for rubber fragment detachment during use.
What is being recalled
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.
Why
Potential for rubber fragment detachment during use.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution.
How to tell if yours is affected
Model/Catalog Number: MAJ-1218. UDI-DI: 14953170154291. All Lot Numbers. 20 units per box.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1489-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | January 29, 2026 |
| Reported | March 11, 2026 |
| Company | Olympus Corporation of the Americas |
| Company location | Center Valley, PA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 1,276 boxes (20 units per box) |
More recalls from Olympus Corporation of the Americas · all medical device recalls · recalls from January 2026