Karl Storz recalls certain cystoscopy scopes that may not achieve expected six-log reduction in microorganisms after disinfection, posing infection risks during medical procedures.
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Karl Storz is recalling specific models of cystoscopy scopes that may not disinfect properly, potentially leading to infections during medical procedures. This recall affects scopes sold since January 2018 with certain serial numbers.
The scopes may not achieve the required six-log reduction in microorganisms after disinfection, meaning harmful bacteria could survive. This could lead to infections during medical procedures if the scopes are reused without proper cleaning.
Medical professionals using these scopes for procedures may be affected. Patients undergoing procedures with these scopes could face infection risks if the scopes are not properly disinfected.
Check for the model numbers 11272V, 11272VA, 11272VAK, 11272VU, or 11272VUK. These scopes were sold starting in January 2018 with specific UDI codes listed in the recall notice.
Identify the model number on your scope to see if it matches the recalled models listed in the recall notice.
Reach out to Karl Storz Endoscopy for guidance on next steps if your scope is affected.
The recall is due to a failure to achieve the expected six-log reduction in microorganisms after disinfection, which could lead to infections during medical procedures.
Check the model number on your scope; affected models include 11272V, 11272VA, 11272VAK, 11272VU, or 11272VUK, and were sold starting in January 2018 with specific UDI codes.
Contact Karl Storz Endoscopy for guidance on next steps; they may provide instructions for proper disinfection or replacement.
We’ve drafted a message you can send Karl Storz to request your refund or repair — edit it as you like.
Subject: Recall Z-1062-2022 — Karl Storz Karl Storz Hello, I own a Karl Storz that is covered by recall Z-1062-2022 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.