Z-0941-2024 Class II Ongoing
FDA device recall Z-0941-2024 was initiated by Olympus Corporation of the Americas on November 10, 2023 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 3354 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 7, 2024
- Initiation Date
- November 10, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3354 units
Product 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
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.
Distribution Pattern
Nationwide. Foreign: AU BR BR CA DE HK IN JP SG
Code Information
UDI-DI: 00821925033245 Lot Numbers: 369715, 370108, 370270, 370496, 377814, 378933, 379534, 386461, 386462, 388459