Olympus Endoscope Reprocessor OER-Mini-For use in recall: Labeling Error
Olympus Endoscope Reprocessor OER-Mini-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their…
Why was Olympus Endoscope Reprocessor OER-Mini-For use in recalled?
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
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI:- 04953170331619 Serial Numbers: 2300314 and the last three digits less than 314
- Product
- Olympus Endoscope Reprocessor OER-Mini-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their…
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 241 units
- Distribution
- Nationwide
- Recall date
- August 16, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)