medical MODERATE Updated 2026-09-30

Olympus Corporation of the Americas recalls Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11,

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Recalled Product

Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355.

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Hazard / Issue

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,

Issued by

FDA

Distribution: International distribution in the country of Japan.
Lot/Code Info: Model Number: BD-420X-1355. UDI-DI: 00821925042261. Lot Number: 460898.

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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