Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11 Recall: Labeling Error
Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355.
Why was Olympus EZDilate Balloon Dilator Wired-guided 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 I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Number: BD-420X-1355. UDI-DI: 00821925042261. Lot Number: 460898.
- Product
- Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355.
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 305 units
- Distribution
- International distribution in the country of Japan.
- Recall started
- August 19, 2026
- Report date
- September 30, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)