FDAFDA · Food and drugs·Recall number Z-2143-2025
Ellik Evacuator. Model Number: 194. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
Published July 30, 2025 · Recall initiated: June 18, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Olympus Corporation of the Americas
- Distributor
- International distribution to the country of Japan.
- Lot
- Model Number: 194. UDI-DI: 00821925002586. All lot numbers
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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