FDAFDA · Food and drugs·Recall number Z-0936-2024
EZDilate Fixed Wire Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1580
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: 00821925033191 Lot Numbers: 360910, 360911, 364014, 364158, 364338, 367646, 367647, 367648, 383363, 383846, 383847, 384058
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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