Z-0936-2024 Class II Ongoing
FDA device recall Z-0936-2024 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: 5232 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
- 5232 units
Product Description
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
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: 00821925033191 Lot Numbers: 360910, 360911, 364014, 364158, 364338, 367646, 367647, 367648, 383363, 383846, 383847, 384058