Z-1613-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 1, 2026
- Initiation Date
- February 12, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,354 units
Product Description
Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.
Reason for Recall
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
Distribution Pattern
US Nationwide distribution.
Code Information
Model Number: N3058140. UDI-DI: 04953170258589. Catalog Number: N3058140. All Lot/Serial Numbers.