Z-0939-2024 Class II Ongoing
FDA device recall Z-0939-2024 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: 1639 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
- 1639 units
Product Description
EZDilate Wire Guided Balloon 6-7-8. indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years) Model: BD-410X-0855
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: 00821925033221 Lot Numbers: 373808, 374005, 379746, 379747, 379835, 379836, 381157