Recall Z-2676-2026 ยท FDT Duodenoscope And Accessories, Flexible/Rigid
Olympus Corporation of the Americas
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
| Date | Jul 7, 2026 (initiated Jun 5, 2026) |
| Status | Open, Classified |
| 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. |
| Root cause | Device Design |
| Action | Olympus issued an UREGNT: MEDICAL DEVICE REMOVAL notice to it consignees on 6/5/2026 via 2nd day courier. The notice explained the issue, risk to heath, and requested the following be taken: "1. Examine your inventory for the previous design of the Single Use Distal Covers, model MAJ-2315 (see Fig.1-6 above and list of affected lot numbers). 2. All older versions of this product should be returned to Olympus and replaced with the newly designed version. " Transition to the newly designed version as soon as possible by placing an order through Customer Service at 1-800-848-9024, option |
| Quantity | 988700 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K220587 | Evis Exera III Duodenovideoscope Olympus TJF-Q190V Olympus Medical Systems Corp., May 11, 2022 |