ENDOSCOPE REPROCESSOR recallZ-1612-2026 · Olympus Corporation of the Americas · initiated Feb 12, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
FDA root cause category: Reprocessing Controls
What the company is doing
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.
Recall details
- Recall number
- Z-1612-2026
- Status
- Open, Classified
- Initiated by the company
- Feb 12, 2026
- Posted by the FDA
- Mar 20, 2026
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 2,929 units
- Product code
- FEB
- FDA submissions
- K201920
- Distribution
- US Nationwide distribution.
Product description
Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.
Code information (models, lots, serial numbers)
Model Number: N5789340. UDI-DI: 04953170404047. Catalog number: N5789340. All Lot/Serial Numbers.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ENDOSCOPE REPROCESSOR OER-EliteOlympus Medical Systems Corp. · Accessories, cleaning, for endoscope4 recalls323 reports
Product lines
Other devices under the same FDA submission
3 devices cleared under K201920 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- WATER FILTER MAJ-824Olympus Medical Systems Corp. · ACCESSORIES, CLEANING, FOR ENDOSCOPE7 reports
- AIR FILTER MAJ-823Olympus Medical Systems Corp. · ACCESSORIES, CLEANING, FOR ENDOSCOPE2 reports
- RETAINING RACK MAJ-840Olympus Medical Systems Corp. · ACCESSORIES, CLEANING, FOR ENDOSCOPE1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 98371).
- Z-1610-2026 · Open, ClassifiedOlympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.
- Z-1611-2026 · Open, ClassifiedOlympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444.
- Z-1613-2026 · Open, ClassifiedOlympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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