FDAFDA · Food and drugs·Recall number Z-0941-2024
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
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: 00821925033245 Lot Numbers: 369715, 370108, 370270, 370496, 377814, 378933, 379534, 386461, 386462, 388459
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.