Karl Storz recalls HD-VIEW flexible cysto-urethroscopes from 2018-2021 with disinfection failure risk. Products may not reduce microorganisms as expected after cleaning.
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Karl Storz is recalling certain HD-VIEW flexible cysto-urethroscopes 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 disinfection process for these devices may not achieve the required six-log reduction in microorganisms. This means the devices could become contaminated with harmful bacteria after cleaning, increasing infection risk during medical procedures.
Healthcare professionals using the recalled cysto-urethroscopes for medical procedures are most at risk. Patients using these devices during procedures may also be affected if proper disinfection isn't achieved.
Check for model numbers 11272VH-TL, 11272VHK-TL, 11272VHU-TL, or 11272VHUK-TL with serial numbers manufactured since January 2018. The UDI code 4048551449677 or 4048551449684 may also indicate the recalled units.
Identify the model number and serial date to confirm if your device is recalled.
The disinfection process may not achieve the expected six-log reduction in microorganisms, increasing infection risk during medical procedures.
Check the model number and serial date to see if it's recalled. If it is, contact Karl Storz for further instructions.
Yes, models 11272VH-TL, 11272VHK-TL, 11272VHU-TL, and 11272VHUK-TL manufactured since January 2018 are affected.
We’ve drafted a message you can send Karl Storz to request your refund or repair — edit it as you like.
Subject: Recall Z-1063-2022 — Karl Storz Karl Storz Hello, I own a Karl Storz that is covered by recall Z-1063-2022 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.
