Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm recall
Olympus Corporation of the Americas recalled Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm on September 30, 2026 because of 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,. It was sold in International distribution in the country of Japan..
Why it was 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's recalled
Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355.
Quantity: 305 units
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- Olympus Corporation of the Americas, Center Valley, PA
- Date
- Severity
- Class II
the product could cause temporary or reversible health problems. - Where sold
- International distribution in the country of Japan.
- Status
- Ongoing
- Recall number
- Z-3216-2026
- Source
- U.S. Food and Drug Administration
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