FDAHealthJune 18, 2025
Olympus Corporation of the Americas — Ellik Latex Bulb, Ellik Evacuator. Model Number: 194-2. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection
⚠️ Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Is this relevant to me?
- Geography
- Unknown
- Source agency
- FDA
- Category
- Health
- Published
- June 18, 2025
International distribution to the country of Japan.
What's affected?
- Product
- Ellik Latex Bulb, Ellik Evacuator. Model Number: 194-2. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
- Lot code
- s
Additional details
Model Number: 194-2. UDI: 00821925002593. All lot numbers
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 48 units.
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