Z-2141-2025 Class II Ongoing
FDA device recall Z-2141-2025 was initiated by Olympus Corporation of the Americas on June 18, 2025 and is designated Class II. Reason for recall: Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU). The recall status is ongoing. Affected quantity: 16 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 30, 2025
- Initiation Date
- June 18, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16 units
Product Description
Glass Body For 194 Ellik Evacuator. Model Number: 190A. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
Reason for Recall
Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Distribution Pattern
International distribution to the country of Japan.
Code Information
Model Number: 190A. UDI-DI: 00821925003538. All lot numbers