Olympus Corporation of the Americas recalls Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355.
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,
Read the official notice →- Date
- 2026-09-30
- Country
- United States
- Brand
- Olympus Corporation of the Americas
- Product
- Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355.
- Classification
- Class II
- Units
- International distribution in the country of Japan.
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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