Recall Weekly
Moderate riskFDA DeviceClass II

Olympus OER-Elite endoscope reprocessor incompatible with MAJ-1443 and MAJ-1444 adapters

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.

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

What to do

  1. Check if your facility uses the OER-Elite (Model N5789340) or OER-Pro reprocessor
  2. Verify whether you have MAJ-1443 or MAJ-1444 adapters
  3. Contact Olympus or your equipment supplier to confirm compatible adapters for your reprocessor
  4. Do not use incompatible adapters with your reprocessor
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 4 products — see all of them.

Details

Units affected
2,929 units
Illnesses reported
None reported
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Classification
Class II
Recall number
Z-1612-2026

In the FDA's words

Description
Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340. The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors. Model Number: N5789340. UDI-DI: 04953170404047. Catalog number: N5789340. All Lot/Serial Numbers. Distribution: US Nationwide distribution. Affected quantity: 2,929 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.

More from Olympus

See all

Related topics

OtherMedical devicesSold nationwideMore from FDA Device