Recall Z-3216-2026 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Olympus Corporation of the Americas
Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355.
| Date | Sep 18, 2026 (initiated Aug 19, 2026) |
| Status | Open, Classified |
| Reason | 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, |
| Root cause | Process control |
| 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. |
| Quantity | 305 units |
| Distribution | International distribution in the country of Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.