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U.S. Department of Health and Human Services

Class 2 Device Recall Olympus EZDilate Endoscopic Balloon Dilator

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 Class 2 Device Recall Olympus EZDilate Endoscopic Balloon Dilatorsee related information
Date Initiated by FirmAugust 19, 2026
Date PostedSeptember 18, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3216-2026
Recall Event ID 99627
Product Classification Stents, drains and dilators for the biliary ducts - Product Code FGE
ProductOlympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355.
Code Information Model Number: BD-420X-1355. UDI-DI: 00821925042261. Lot Number: 460898.
FEI Number 2429304
Recalling Firm/
Manufacturer		 Olympus Corporation of the Americas
3500 Corporate Pkwy
Center Valley PA 18034-8229
For Additional Information ContactAshley Troiani
484-5531029
Manufacturer Reason
for Recall		Potential for the inflation chart label affixed to the shaft of the device to be incorrect and indicate a balloon diameter of 18, 19, or 20 mm,
FDA Determined
Cause 2		Process control
ActionOlympus notified their direct customer on about 08/19/2026 via emailed "URGENT: MEDICAL DEVICE RECALL/PRODUCT REMOVAL" letter. The consignee was instructed to examine inventory for affected units, acknowledge receipt of the recall notification by completing and returning the Reply Form, arrange for the return of affected units for replacement, and if affected units have been further distributed, notify those customers.
Quantity in Commerce305 units
DistributionInternational distribution in the country of Japan.
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.
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