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U.S. Department of Health and Human Services

Class 2 Device Recall Olympus Single Use Biopsy Valve

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 Class 2 Device Recall Olympus Single Use Biopsy Valvesee related information
Date Initiated by FirmJanuary 29, 2026
Date PostedMarch 03, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1488-2026
Recall Event ID 98240
510(K)NumberK061313 
Product Classification Bronchoscope (flexible or rigid) - Product Code EOQ
ProductOlympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The MAJ-210 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent reflux of body fluids.
Code Information Model/Catalog Number: MAJ-210. UDI-DI: 14953170152433, 14953170452069. All Lot Numbers. 20 units per box.
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		Potential for rubber fragment detachment during use.
FDA Determined
Cause 2		Under Investigation by firm
ActionOlympus 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.
Quantity in Commerce95,882 boxes (20 per box)
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 = EOQ
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