Karl Storz recalls adult cystoscopes with serial numbers from January 2018 due to failure to achieve six-log reduction in microorganisms after disinfection.
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Karl Storz is recalling adult cystoscopes and kits produced from January 2018 because they may not reduce microorganisms to a safe level after disinfection. This could lead to infections if used improperly.
The cystoscopes may not reduce microorganisms to a safe level after disinfection, potentially leading to infections during medical procedures. This happens because the disinfection process does not achieve the required six-log reduction in bacteria.
Medical professionals using the recalled cystoscopes for urological procedures are most at risk. Patients undergoing procedures with these devices could face infection risks.
Check for the model numbers 11272C1, 11272C2, 11272CU1, and kit numbers 11272CK2, 11272CUK1. These were manufactured and distributed starting in January 2018 with UDI codes 4048551226100 or 4048551226162.
Identify the model numbers and UDI codes to confirm if your device is recalled.
The cystoscopes may not reduce microorganisms to a safe level after disinfection, potentially leading to infections during medical procedures.
Model numbers 11272C1, 11272C2, 11272CU1, and kit numbers 11272CK2, 11272CUK1 manufactured from January 2018.
Check for the model numbers and UDI codes listed in the recall notice, which were manufactured and distributed starting in January 2018.
We’ve drafted a message you can send Karl Storz to request your refund or repair — edit it as you like.
Subject: Recall Z-1061-2022 — Karl Storz Karl Storz Hello, I own a Karl Storz that is covered by recall Z-1061-2022 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.
