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Karl Storz Endoscopy recalls 11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019)
Recalled May 18, 2022 · FDA recall Z-1055-2022 · Karl Storz Endoscopy
Hazard
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. · FDA Class II
Units
All Serial Numbers manufactured/distributed since January 2018
Sold at
U.S. Nationwide distribution in the states of FL, KY, LA, MA, MI, MO, MT, NC, NH, NJ, OK, SC, TX and WA.
Description
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Product
11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019)
Manufacturer(s)
Karl Storz Endoscopy
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →