FDA-Device2026-04-01Class IIPROCESSING DEFECT

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

OTHERNationwide distribution

Stop using Olympus MAJ-1444 valve with OER reprocessors

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
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
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

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