Olympus Glass Body for 194 Ellik Evacuator. Model Number:… recallZ-2721-2026 · Olympus Corporation of the Americas · initiated May 5, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
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 notice was sent to consignees on 06/30/2026 with further clarification regarding instructions to be used to sterilize affected devices going forward.
Recall details
- Recall number
- Z-2721-2026
- Status
- Open, Classified
- Initiated by the company
- May 5, 2026
- Posted by the FDA
- Jul 10, 2026
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 3,663 units
- Product code
- KQT
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Japan, EU, and Latin America.
Product description
Olympus Glass Body for 194 Ellik Evacuator. Model Number: 190A.
Code information (models, lots, serial numbers)
Model Number: 190A. UDI-DI: 00821925003538. All Lot Numbers.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Gyrus ACMI 190AGyrus ACMI, LLC · EVACUATOR, GASTRO-UROLOGY2 recalls0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 98869).
- Z-2718-2026 · Open, ClassifiedOlympus Toomey Evacuator 30cc with Adaptor. Model Number: 188.
- Z-2719-2026 · Open, ClassifiedOlympus Toomey Evacuator 50cc with Adaptor. Model Number: 188A.
- Z-2720-2026 · Open, ClassifiedOlympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Number: 194.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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