Recall Z-0905-2025 ยท FBN Choledochoscope And Accessories, Flexible/Rigid
Olympus Corporation of the Americas
Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891. This instrument is designed to be attached to the instrument channel port of Olympus endoscopes to allow both irrigation and the use of endo-therapy accessories.
| Date | Jan 16, 2025 (initiated Dec 18, 2024) |
| Status | Open, Classified |
| Reason | Potential for inadvertent retention of biomaterial when the reprocessing procedure is not performed as instructed, so as not completely removing and disassembling the device. |
| Root cause | Labeling design |
| Action | Olympus notified consignees on about 12/18/2024 via letter. Consignees were instructed to utilize alternative devices to the MAJ-891 according to the provided compatibility table provided, ensure all personnel are completely knowledgeable and thoroughly trained on the content of this letter and the MAJ-891 reprocessing instructions, acknowledge receipt of the letter through the Olympus portal, https://olympusamerica.com/recall, and notify customers if the units have been further distributed. Additionally, Olympus will contact customers to schedule a mutually beneficial time for an Olympus Fi |
| Quantity | 30,140 units |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K912120 | URF-P2 URETERORENOFIBERSCOPE/CHOLEDOCHOFIBERSCOPE Olympus Corp., Aug 7, 1991 |