Karl Storz recalls flexible cystoscopes from 2018 with disinfection failure risk. Products may not reduce microorganisms to six log levels after cleaning.
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Karl Storz is recalling certain flexible cystoscopes made since January 2018 due to a disinfection process that may not reduce microorganisms to the expected six-log level. This could lead to infections if the device is not properly cleaned.
The disinfection process for these cystoscopes may not achieve the required six-log reduction in microorganisms. This means the devices could harbor harmful bacteria even after cleaning, increasing infection risk during medical procedures.
Medical professionals using the recalled cystoscopes for urological procedures are affected. Patients undergoing procedures with these devices may be at risk of infection.
Check for the model numbers 11274BCU1 or 11274BCUK1 with serial numbers manufactured since January 2018. The UDI code 4048551408155 is also associated with this recall.
Look for the model numbers 11274BCU1 or 11274BCUK1 with serial numbers manufactured since January 2018.
The disinfection process may not achieve the expected six-log reduction in microorganisms, increasing infection risk during medical procedures.
Check the serial number and model to see if it matches the recalled items. Contact Karl Storz Endoscopy for further instructions.
The recall is due to infection risk from inadequate disinfection, not physical injury. There is no mention of serious injury in the official notice.
We’ve drafted a message you can send Karl Storz Endoscopy to request your refund or repair — edit it as you like.
Subject: Recall Z-1066-2022 — Karl Storz Endoscopy Karl Storz Endoscopy Hello, I own a Karl Storz Endoscopy that is covered by recall Z-1066-2022 from Karl Storz Endoscopy. 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.
