FDA Enforcement
Class II
Ongoing
Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.
Recall: Z-1613-2026
·
Reported April 1, 2026
Enforcement
- Recall Number
- Z-1613-2026
- Event ID
- 98371
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Olympus Corporation of the Americas
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 1, 2026
- Initiation Date
- February 12, 2026
- Classification Date
- March 20, 2026
- Address
- 3500 Corporate Pkwy, Center Valley, PA, 18034-8229, United States
Description
Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.
Reason
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
Code Info
Model Number: N3058140. UDI-DI: 04953170258589. Catalog Number: N3058140. All Lot/Serial Numbers.
Distribution
US Nationwide distribution.
Quantity
3,354 units