FDA Medical devices recall ·
Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm recall
- Recall number
- Z-3216-2026
- Date
- (initiated August 19, 2026)
- Company / brand
- Olympus Corporation of the Americas
3500 Corporate Pkwy, Center Valley, PA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 305 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355.
Why was it recalled?
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,
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model Number: BD-420X-1355. UDI-DI: 00821925042261. Lot Number: 460898.
Distribution
International distribution in the country of Japan.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-3216-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.