Class II — Olympus Corporation of the Americas
| Recalling firm | Olympus Corporation of the Americas |
|---|---|
| Classification | Class II |
| Status | Ongoing |
| 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, |
| Product | Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355. |
| Quantity | 305 units |
| Distribution | International distribution in the country of Japan. |
| Initiated | 2026-08-19 |
| Classified | 2026-09-18 |
| Recall number | Z-3216-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Olympus Corporation of the Americas (Z-3216-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99627/
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