Z-2496-2023 Class II Ongoing
FDA device recall Z-2496-2023 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: 9449 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
- 9449 units
Product Description
Olympus Bronchovideoscope, Models BF-1TH190, BF-H190, BF-Q170, & BF-Q190.
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: 04953170335181, 04953170434778, 04953170335174, 04953170434754, 04953170342912, 04953170335198, 04953170434792; All Serial Numbers.