FDAFDA · Food and drugs·Recall number Z-0935-2024
EZDilate Fixed Wire Balloon 11-12-13. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1380
Published February 7, 2024 · Recall initiated: November 10, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Olympus Corporation of the Americas
- Distributor
- Nationwide. Foreign: AU BR BR CA DE HK IN JP SG
- Lot
- UDI-DI: 00821925033184 Lot Numbers: 369624, 377715
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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