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Home › FDA recalls › Olympus Single Use Biopsy Valve.
CLASS II · ModerateFDA

Olympus Corporation of the Americas recalls Olympus Single Use Biopsy Valve.

📅 Jan 29, 2026 · 📍 Nationwide
Recalling company
Olympus Corporation of the Americas
Product
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.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Jan 29, 2026
Reported
Mar 11, 2026
Distribution
US Nationwide distribution.
Status
Ongoing
Quantity
1,276 boxes (20 units per box)
Lot / codes
Model/Catalog Number: MAJ-1218. UDI-DI: 14953170154291. All Lot Numbers. 20 units per box.
Company location
Center Valley, PA
Recall type
Voluntary: Firm initiated
Recall number
Z-1489-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1489-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.