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U.S. Department of Health and Human Services

Class 2 Device Recall Olympus Endoscope Reprocessor OERElite

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 Class 2 Device Recall Olympus Endoscope Reprocessor OERElitesee related information
Date Initiated by FirmFebruary 12, 2026
Date PostedMarch 20, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1612-2026
Recall Event ID 98371
510(K)NumberK201920 
Product Classification Accessories, cleaning, for endoscope - Product Code FEB
ProductOlympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.
Code Information Model Number: N5789340. UDI-DI: 04953170404047. Catalog number: N5789340. All Lot/Serial Numbers.
FEI Number 2429304
Recalling Firm/
Manufacturer		 Olympus Corporation of the Americas
3500 Corporate Pkwy
Center Valley PA 18034-8229
For Additional Information ContactCynthia Ow
647-9993203
Manufacturer Reason
for Recall		The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
FDA Determined
Cause 2		Reprocessing Controls
ActionOlympus 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.
Quantity in Commerce2,929 units
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FEB
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