Recall Z-3216-2026
Olympus Corporation of the Americas · initiated August 19, 2026
Product
Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355.
Codes / lots: Model Number: BD-420X-1355. UDI-DI: 00821925042261. Lot Number: 460898.
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: Process control
Action taken
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.
Details
- Recall number
- Z-3216-2026
- Initiated
- August 19, 2026
- Posted by FDA
- September 18, 2026
- Product code
- FGE – Stents, Drains And Dilators For The Biliary Ducts
- Quantity
- 305 units
- Distribution
- International distribution in the country of Japan.
- Recalling firm
- Olympus Corporation of the Americas, Center Valley, PA