Ellik Evacuator. Model Number: 194. The Ellik Evacuator and adapter accessories are compatible wi
Pending LLM rewrite. Source: FDA_DEVICE Z-2143-2025.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
The recalled product
- Product
- Ellik Evacuator. Model Number: 194. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model Number: 194. UDI-DI: 00821925002586. All lot numbers
Distribution
Distribution scope not specified by the agency.
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