Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.
FDA device recall Z-1613-2026 · posted 2026-03-20 · Open, Classified
Recall details
- 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.
- Action taken
- Olympus notified consignees on about 02/12/2026 via URGENT: MEDICAL DEVICE CORRECTION letter. Consignees were instructed to immediately cease reprocessing the MAJ-1443 and MAJ-1444 valves in an OER-Pro or OER-Elite and ensure all personnel are completely knowledgeable and thoroughly trained on the content of this notification and the full extent of the MAJ-1443 and MAJ-1444 reprocessing steps as detailed in the provided Instructions for Use (IFU). The updated IFU can also be accessed electronically through OlympusConnect.com. Additionally, consignees were instructed to replace any existing copies of the MAJ-1443/MAJ-1444 IFU with the updated IFU provided in this letter, identify and notify all customers if affected units were further distributed and complete and confirm receipt of the notification via the Olympus web portal.
- Root cause
- Reprocessing Controls
- Status
- Open, Classified
- Product code
- FEB
- Quantity affected
- 3,354 units
- Distribution
- US Nationwide distribution.
- Date initiated
- 2026-02-12
- Date posted
- 2026-03-20
- Location
- Center Valley, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ENDOSCOPE REPROCESSOR OER-PRO MODEL OER-PRO (K103264) | Olympus Medical Systems Corporation | 2011-02-23 |