FDAFDA recall Z-3216-2026 · Sep 30, 2026
Olympus Corporation of the Americas: Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11 recall
Recall found
Product
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,
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Model Number: BD-420X-1355. UDI-DI: 00821925042261. Lot Number: 460898.
- Quantity
- 305 units
- Distribution
- International distribution in the country of Japan.
- Recalling firm
- Olympus Corporation of the Americas, Center Valley, PA
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-08-19
Source: openFDA enforcement record Z-3216-2026 · search recall number Z-3216-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.