- Recalling firm
- Olympus Corporation of the Americas
- Reason for recall
- The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
- Affected products (lot / model / serial)
- Model Number: N3058140. UDI-DI: 04953170258589. Catalog Number: N3058140. All Lot/Serial Numbers.
- Units affected
- 3,354 units
- Distribution pattern
- US Nationwide distribution.
- Firm location
- Center Valley, PA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-1613-2026
- Recall initiated
- February 12, 2026
- FDA classification date
- March 20, 2026
- FDA report date
- April 1, 2026
- FDA event ID
- 98371
- Last updated on HTM Vibe
- July 24, 2026