FDAFDA recall Z-2676-2026 · Jul 15, 2026
Olympus Corporation of the Americas: Olympus Single Use Distal Cover recall
Recall found
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 for recall
Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- UDI/DI: 04953170441271, Lot Numbers: H2530 or later
- Quantity
- 988700 units
- Distribution
- US Nationwide distribution.
- Recalling firm
- Olympus Corporation of the Americas, Center Valley, PA
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-06-05
Source: openFDA enforcement record Z-2676-2026 · search recall number Z-2676-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.