- Recalling firm
- Olympus Corporation of the Americas
- 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,
- Affected products (lot / model / serial)
- Model Number: BD-420X-1355. UDI-DI: 00821925042261. Lot Number: 460898.
- Units affected
- 305 units
- Distribution pattern
- International distribution in the country of Japan.
- Firm location
- Center Valley, PA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- E-Mail
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-3216-2026
- Recall initiated
- August 19, 2026
- FDA classification date
- September 18, 2026
- FDA report date
- September 30, 2026
- FDA event ID
- 99627
- Last updated on HTM Vibe
- October 6, 2026
