Z-2500-2023 Class II Ongoing
FDA device recall Z-2500-2023 was initiated by Olympus Corporation of the Americas on July 27, 2023 and is designated Class II. Reason for recall: Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large. The recall status is ongoing. Affected quantity: 3949 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 6, 2023
- Initiation Date
- July 27, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3949 units
Product Description
Olympus Bronchovideoscope, Models BF-P190 & BF-XP190.
Reason for Recall
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
Distribution Pattern
US Nationwide distribution.
Code Information
UDI-DI: 04953170342110, 04953170434983, 04953170342134, & 04953170434990; All Serial Numbers.