Recall Weekly
Moderate riskFDA DeviceClass II

Olympus MAJ-1443 and MAJ-1444 endoscope suction valves no longer compatible with OER-Pro and OER-Elite reprocessors

Olympus endoscope suction valves (models MAJ-1443 and MAJ-1444) are no longer compatible with Olympus OER-Pro and OER-Elite automated cleaning systems. Using these valves with these reprocessors may result in improper cleaning and sterilization of medical equipment.

From the FDA notice · Read the official notice ↗ · All Olympus recalls

What to do

  1. Discontinue use of MAJ-1443 and MAJ-1444 suction valves with OER-Pro and OER-Elite reprocessors
  2. Contact Olympus Corporation for guidance on replacement parts or alternative reprocessing methods
  3. Review your endoscope equipment inventory to identify affected units
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 4 products — see all of them.

Details

Units affected
47,383 units
Illnesses reported
None reported
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Classification
Class II
Recall number
Z-1610-2026

In the FDA's words

Description
Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443. The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors. Model Number: MAJ-1443. UDI-DI: 04953170355912. Catalog Number: N5363430. All Lot/Serial Numbers. Distribution: US Nationwide distribution. Affected quantity: 47,383 units
Hazard
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.

4 products in this recall

Olympus endoscope valves and reprocessors recalled over compatibility issue

Olympus is recalling four endoscope products because the MAJ-1443 and MAJ-1444 valves are no longer compatible with the OER-Pro and OER-Elite automated endoscope reprocessors. The recall covers about 139,000 units across the US, and no injuries have been reported.

The agency lists each product separately. Check every one you might have.

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