Z-3216-2026 Class II Ongoing
FDA device recall Z-3216-2026 was initiated by Olympus Corporation Of The Americas on Aug 19, 2026 and is designated Class II. 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, The recall status is ongoing. Affected quantity: 305 units.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 30, 2026
- Initiation Date
- Aug 19, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 305 units
Product Description
Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355.
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,
Distribution Pattern
International distribution in the country of Japan.
Code Information
Model Number: BD-420X-1355. UDI-DI: 00821925042261. Lot Number: 460898.