FDA Medical devices recall ·
Olympus Endoscope Reprocessor OER-Elite recall
- Recall number
- Z-1612-2026
- Date
- (initiated February 12, 2026)
- Company / brand
- Olympus Corporation of the Americas
3500 Corporate Pkwy, Center Valley, PA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 2,929 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.
Why was it recalled?
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model Number: N5789340. UDI-DI: 04953170404047. Catalog number: N5789340. All Lot/Serial Numbers.
Distribution
US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1612-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.