Olympus Corporation Of The Americas: Accessories, Cleaning, For Endoscope
Recall Summary Olympus Corporation is recalling the MAJ-1443 and MAJ-1444 cleaning accessories for endoscope reprocessors because they are no longer compatible with the OER-Pro and OER-Elite automated endoscope reprocessors. This recall affects medical facilities across all U.S. states and the District of Columbia that use these accessories with the affected reprocessor models. The FDA classifies this as a Class II recall, meaning use of the incompatible accessories could result in inadequate cleaning of medical equipment.
- Recalling firm
- Olympus Corporation of the Americas
- Product
- Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.
- Reason
- The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-02-12
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/8bf3a0ed-9960-403d-8ed5-ec49d838c07b