Olympus EZDilate Endoscopic Balloon Dilators
Reason given by FDA: 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.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Olympus Corporation of the Americas, located in Center Valley, Pennsylvania, recalled its Olympus EZDilate Endoscopic Balloon Dilator Wire-guided 11, 12, 13mm, model BD-420X-1355, because the inflation chart label on the shaft may be incorrect and show a balloon diameter of 18, 19, or 20 mm. The recall began on August 19, 2026, and was added to the FDA's Enforcement Report on September 18, 2026. The 305 units were distributed internationally in Japan.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the model number, UDI-DI and lot code listed under your product.
Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm.
- Model
- BD-420X-1355
- UDI-DI
- 00821925042261
- Lot
- 460898
Details
- Company began the recall
- Sold in
International distribution in the country of Japan.
- Event ID
- 99627
- Recall No.
- Z-3216-2026
- Company
- Olympus Corporation of the AmericasCenter Valley, Pennsylvania
- Hazard
- Labeling error
- Quantity recalled
- 305 units
- Recall type
- Voluntary: Firm initiated
- Customers told by
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
