Karl Storz recalls flexible bronchoscopes from 2018-2019 with potential inadequate disinfection, risking infection. Affected units have specific serial numbers and UDI codes.
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Karl Storz is recalling certain flexible bronchoscopes made from January 2018 onward due to a risk that disinfection may not reduce microorganisms to the expected level. This could lead to infections if the device is used without proper cleaning.
The bronchoscope may not achieve the required six-log reduction in microorganisms after disinfection. This means harmful bacteria and viruses could remain on the device, potentially causing infections during medical procedures.
Healthcare professionals using the recalled bronchoscopes are most at risk. Patients undergoing procedures with these devices may also be affected if the disinfection process fails.
Check for the model numbers 11005BC1 or 11005BCK1 with UDI code 04048551225738. These units were manufactured and distributed starting in January 2018.
Look for the model numbers 11005BC1 or 11005BCK1 with UDI code 04048551225738 on the device.
The recall is due to a risk that disinfection may not reduce microorganisms to the expected level, potentially leading to infections.
Check for the model numbers 11005BC1 or 11005BCK1 with UDI code 04048551225738, which were manufactured and distributed starting in January 2018.
The recall record does not specify a remedy, so contact Karl Storz directly for guidance.
We’ve drafted a message you can send Karl Storz to request your refund or repair — edit it as you like.
Subject: Recall Z-1055-2022 — Karl Storz Karl Storz Hello, I own a Karl Storz that is covered by recall Z-1055-2022 from Karl Storz. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
