FDA Medical devices recall ·
Ellik Evacuator recall
- Recall number
- Z-2143-2025
- Date
- (initiated June 18, 2025)
- Company / brand
- Olympus Corporation of the Americas
3500 Corporate Pkwy, Center Valley, PA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 11 units
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Ellik Evacuator. Model Number: 194. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
Why was it recalled?
Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model Number: 194. UDI-DI: 00821925002586. All lot numbers
Distribution
International distribution to the country of Japan.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2143-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.