Olympus Corporation of the Americas recalls Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11
- Recalling company
- Olympus Corporation of the Americas
- Product
- Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355.
- 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,
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Aug 19, 2026
- Reported
- Sep 30, 2026
- Distribution
- International distribution in the country of Japan.
- Status
- Ongoing
- Quantity
- 305 units
- Lot / codes
- Model Number: BD-420X-1355. UDI-DI: 00821925042261. Lot Number: 460898.
- Company location
- Center Valley, PA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-3216-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-3216-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.