Z-1046-2022 Class II Ongoing
FDA device recall Z-1046-2022 was initiated by Olympus Corporation Of The Americas on Mar 8, 2022 and is designated Class II. Reason for recall: Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a… The recall status is ongoing. Affected quantity: 60 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 18, 2022
- Initiation Date
- Mar 8, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 60 units
Product Description
BF-MP60: OES Bronchofiberscope
Reason for Recall
Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a recommendation on using sterilization
Distribution Pattern
US Nationwide distribution.
Code Information
All serial numbers. UDI: 04953170339394
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1046-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026