Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. The MAJ-1218 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent leakage of body fluids.
FDA Recall Z-1489-2026 · Posted 2026-03-03
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Recalling FirmOlympus Corporation of the Americas
Recall StatusOpen, Classified
Product CodeEOQ
Date Initiated2026-01-29
Product Quantity1,276 boxes (20 units per box)
Reason for Recall
Potential for rubber fragment detachment during use.
Firm Action
Olympus notified consignees on about 01/29/2026 via letter titled URGENT: FIELD SAFETY NOTICE. Consignees were instructed to carefully read the content of the notification, ensure all personnel are completely knowledgeable and thoroughly trained on the content of this notification, and that they may continue using the devices as per the notification and instructions for use.
Olympus is highlighting the importance of strictly adhering to the Inspection of the Biopsy Valve and Inserting and Withdrawing the Endo-therapy accessories sections in the IFU related to the detachment of fragment from the slit part of rubber.
Consignees were requested to acknowledge receipt of the notification via their portal and if product has been further distributed to notify those consignees.
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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