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Recall Observatory FDA recall evidence

Device product

11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019)

Z-1055-2022

April 01, 2022

Class II

Product summary

Firm
Karl Storz Endoscopy
Event
Event 89881
Status
Ongoing
Classification
Class II
Quantity
All Serial Numbers manufactured/distributed since January 2018
Official record key
device-enforcement:Z-1055-2022

Official wording

Reason: Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.

Code information: 11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019) UDI Code: 04048551225738 All Serial Numbers manufactured/distributed since January 2018

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.