🔍 RecallPedia

EZDilate Wire Guided Balloon- Indicated for use in adult and adolescent (> 12 years) populations to endoscopically dilate strictures of the alimentary tract. It is also indicated in adults for endoscopic dilatation of the Sphincter of Oddi with or without prior sphincterotomy. Model/Catalog Number: BD-410X-1055

Class I - Dangerous
🏥 Medical Devices Recalled: September 13, 2024 Olympus Corporation of the Americas Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    UDI-DI: 821925033238 Lot: 408987
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Olympus Corporation of the Americas
Reason for Recall:
Mislabeled Glo Cath Label (attached to the device) states: 11 mm, 12 mm, 13 mm however the balloon is 8.5mm, 9.5mm and 10.5 mm and may result in prolonged surgery. All other labeling is correct for the balloon, including the Shelf Box with Front Box Label and Circular Star Label and the balloon Pouch
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

EZDilate Wire Guided Balloon- Indicated for use in adult and adolescent (> 12 years) populations to endoscopically dilate strictures of the alimentary tract. It is also indicated in adults for endoscopic dilatation of the Sphincter of Oddi with or without prior sphincterotomy. Model/Catalog Number: BD-410X-1055

Product Codes/Lot Numbers:

UDI-DI: 821925033238 Lot: 408987

Distribution:

Distributed in: US, CA, FL, IL, NJ, NY, PA, TN, VA, WI, DE, IN, SG

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0225-2025

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