Z-1055-2022 Class II Ongoing
FDA device recall Z-1055-2022 was initiated by Karl Storz Endoscopy on Apr 1, 2022 and is designated Class II. Reason for recall: Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. The recall status is ongoing. Affected quantity: All Serial Numbers manufactured/distributed since January 2018.
Recall Details
- Product Type
- Devices
- Report Date
- May 18, 2022
- Initiation Date
- Apr 1, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- All Serial Numbers manufactured/distributed since January 2018
Product Description
11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019)
Reason for Recall
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Distribution Pattern
U.S. Nationwide distribution in the states of FL, KY, LA, MA, MI, MO, MT, NC, NH, NJ, OK, SC, TX and WA.
Code Information
11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019) UDI Code: 04048551225738 All Serial Numbers manufactured/distributed since January 2018
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1055-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026