Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355.
FDA Recall Z-3216-2026 · Posted 2026-09-18
Recalling FirmOlympus Corporation of the Americas
Recall StatusOpen, Classified
Product CodeFGE
Date Initiated2026-08-19
Product Quantity305 units
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,
Firm Action
Olympus 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.
Root Cause
Process control
Distribution Pattern
International distribution in the country of Japan.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.