Z-3286-2018 Class II Terminated
FDA device recall Z-3286-2018 was initiated by Olympus Corporation Of The Americas on Aug 8, 2018 and is designated Class II. Reason for recall: The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port. The recall status is terminated (terminated May 17, 2022). Affected quantity: 1605.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 10, 2018
- Initiation Date
- Aug 8, 2018
- Termination Date
- May 17, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1605
Product Description
Bronchovidescope BF-1T240
Reason for Recall
The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port.
Distribution Pattern
The products were distributed US nationwide and Canada.
Code Information
all lot codes
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3286-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026