Olympus Corporation of the Americas recalls Olympus Single Use Distal Cover
- Recalling company
- Olympus Corporation of the Americas
- Product
- Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideoscopes to cover the distal end of the insertion tube and around the forceps elevator; duodenoscope and accessories, flexible/rigid
- Reason
- Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Jun 5, 2026
- Reported
- Jul 15, 2026
- Distribution
- US Nationwide distribution.
- Status
- Ongoing
- Quantity
- 988700 units
- Lot / codes
- UDI/DI: 04953170441271, Lot Numbers: H2530 or later
- Company location
- Center Valley, PA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2676-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2676-2026 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.