FDA-Device2026-04-01Class IIPROCESSING DEFECT
Olympus OER-Elite endoscope reprocessor incompatible with MAJ-1443 and MAJ-1444 adapters
What this means
Olympus has identified that certain adapter models (MAJ-1443 and MAJ-1444) are no longer compatible with the OER-Elite and OER-Pro automated endoscope reprocessors. This incompatibility could affect proper cleaning and sterilization of medical equipment.
- Check if your facility uses the OER-Elite (Model N5789340) or OER-Pro reprocessor
- Verify whether you have MAJ-1443 or MAJ-1444 adapters
- Contact Olympus or your equipment supplier to confirm compatible adapters for your reprocessor
- Do not use incompatible adapters with your reprocessor
The agency's original wording
Hazard
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
Intended for
All ages
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
2,929 units
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1612-2026More Olympus recalls
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- FDA-Device2026-07-22Olympus Toomey Evacuator 50cc Model 188A recalled for inadequate sterilization parameters
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- FDA-Device2026-07-22Olympus Toomey Evacuator 30cc with Adaptor recalled for inadequate sterilization
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