Z-2343-2023 Class II Ongoing
FDA device recall Z-2343-2023 was initiated by Olympus Corporation of the Americas on May 26, 2023 and is designated Class II. Reason for recall: Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer compatible endoscopes for reprocessing in the OERs. The addendum highlights the following changes:… The recall status is ongoing. Affected quantity: 241 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 16, 2023
- Initiation Date
- May 26, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 241 units
Product Description
Olympus Endoscope Reprocessor OER-Mini-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their accessories.
Reason for Recall
Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer compatible endoscopes for reprocessing in the OERs. The addendum highlights the following changes: 1. Removal of LF-V and LF-P as compatible with the OER 2. Change conditions for ETO gas sterilization from 12% EtO to 100% EtO 3. Removing the reusable cleaning brush for the manual cleaning. Single Use brushes remain compatible
Distribution Pattern
Nationwide
Code Information
UDI-DI:- 04953170331619 Serial Numbers: 2300314 and the last three digits less than 314