EZDilate Wire Guided Balloon 11-12-13. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years). Model: BD-410X-1355
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI: 00821925033245 Lot Numbers: 369715, 370108, 370270, 370496, 377814, 378933, 379534, 386461, 386462, 388459
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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:
- Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
- 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 11-12-13. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years). Model: BD-410X-1355
Product Codes/Lot Numbers:
UDI-DI: 00821925033245 Lot Numbers: 369715, 370108, 370270, 370496, 377814, 378933, 379534, 386461, 386462, 388459
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0941-2024
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