FDA-Device2026-04-01Class IIPROCESSING DEFECT

Olympus MAJ-1444 endoscope air/water valve incompatible with OER-Pro and OER-Elite reprocessors

OTHERNationwide distributionMedical devices

What this means

Olympus endoscope air/water valves (models MAJ-1443 and MAJ-1444) are no longer compatible with OER-Pro and OER-Elite automated endoscope reprocessors. Using these valves with these reprocessors may result in incomplete or improper cleaning of endoscopes.

  • Do not use MAJ-1443 or MAJ-1444 valves with OER-Pro or OER-Elite reprocessors
  • Contact Olympus for replacement valves or instructions on compatible alternatives
  • Review your facility's inventory to identify affected units
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
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
89,579 units
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1611-2026

More Olympus recalls

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