Karl Storz recalls certain flexible video urethro cystoscopes from 2018 due to failure to reduce microorganisms during disinfection. Affected models may not be safe for medical use.
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Karl Storz is recalling specific flexible video urethro cystoscopes made from January 2018 onward because they may not properly reduce microorganisms after disinfection. This could lead to infections if used without proper sterilization.
The cystoscopes may not achieve the required six-log reduction in microorganisms after disinfection. This means they could fail to kill enough bacteria, increasing infection risk during medical procedures.
Medical professionals using the recalled cystoscopes are affected. Patients using these devices during procedures may be at risk of infection.
Check for the model numbers 11272VN, 11272VNK, or 11272VNU with UDI code 4048551226186 or 4048551226193. These were manufactured and distributed starting in January 2018.
Identify the model number and UDI code to confirm if your device is affected.
The cystoscope may not achieve the required six-log reduction in microorganisms after disinfection, increasing infection risk.
Check the model number and UDI code to see if it's affected. If so, contact Karl Storz for guidance.
Yes, the device may not properly disinfect, potentially leading to infections during medical procedures.
We’ve drafted a message you can send Karl Storz to request your refund or repair — edit it as you like.
Subject: Recall Z-1064-2022 — Karl Storz Karl Storz Hello, I own a Karl Storz that is covered by recall Z-1064-2022 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.
