FDA-Device2026-04-01Class IIPROCESSING DEFECT
Olympus OER-Elite endoscope reprocessor incompatible with MAJ-1443 and MAJ-1444 adapters
OTHERNationwide distribution
Check your Olympus endoscope reprocessor compatibility
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
Hazard
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
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 Corporation of the Americas recalls
- FDA-Device2026-04-08Olympus SOLTIVE Premium laser system recalled for defective power supply
- FDA-Device2026-04-08Olympus SOLTIVE Pro SuperPulsed Laser System recalled for power supply defect
- FDA-Device2026-04-01Olympus PKS Cutting Forceps recalled for defective welds causing jaw breakage
- FDA-Device2026-04-01Olympus MAJ-1443 and MAJ-1444 endoscope suction valves no longer compatible with OER-Pro and OER-Elite reprocessors
- FDA-Device2026-04-01Olympus PKS Cutting Forceps recalled for defective welds causing jaw breakage
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