Recall Z-2143-2025 ยท KQT Evacuator, Gastro-Urology
Olympus Corporation of the Americas
Ellik Evacuator. Model Number: 194. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
| Date | Jul 21, 2025 (initiated Jun 18, 2025) |
| Status | Open, Classified |
| Reason | Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU). |
| Root cause | Packaging change control |
| Action | Olympus notified consignees on about 06/18/2025 via letter. Consignees were instructed to review the notification and arrange for the return of all affected units on hand, ensure all affected personnel are aware, and notify customers if the affected units were further distributed. Olympus also requested that consignees complete and return the response form acknowledging receipt of the notification. |
| Quantity | 11 units |
| Distribution | International distribution to the country of Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.