Recall Z-2721-2026 ยท KQT Evacuator, Gastro-Urology
Olympus Corporation of the Americas
Olympus Glass Body for 194 Ellik Evacuator. Model Number: 190A.
| Date | Jul 10, 2026 (initiated May 5, 2026) |
| Status | Open, Classified |
| Reason | Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices. |
| Root cause | Under Investigation by firm |
| Action | Olympus notified consignees on about 06/05/2026 via Courier, 2-day delivery. Consignees were requested to examine inventory for affected units. If affected units are on hand, replace any existing sterilization instructions for these products with those provided with the notification and add these instructions to any existing copies of the IFU. Consignees were also instructed to acknowledge receipt of the customer letter through the web portal. If affected units were further distributed, Olympus instructed consignees to identify those customers and forward the notification to them. An updated n |
| Quantity | 3,663 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Japan, EU, and Latin America. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.