Karl Storz recalls certain flexible ureteroscopes due to failure to achieve six-log reduction in microorganisms after disinfection. Affected models include 11278VSA, 11278VSE, 11278VSU, 11278VSUA, and 11278VSUE series with specific UDI codes and production dates from January 2018 onward.
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Karl Storz is recalling specific models of flexible video ureteroscopes (FLEX-XC) because they may not reduce microorganisms to the expected level after disinfection. This could lead to infections if the instruments are used without proper sterilization.
The disinfection process may not reduce microorganisms to the required six-log level, meaning harmful bacteria could survive on the instruments. This increases infection risk during medical procedures if the instruments are not properly sterilized.
Medical professionals using these ureteroscopes for procedures are most at risk, particularly those who handle the instruments without confirming proper disinfection.
Check for the model numbers 11278VSA, 11278VSE, 11278VSU, 11278VSUA, or 11278VSUE with UDI codes listed in the recall notice. These were manufactured from January 2018 onward.
Identify your ureteroscope model by checking the product label for the model numbers 11278VSA, 11278VSE, 11278VSU, 11278VSUA, or 11278VSUE.
Ensure the instruments are properly disinfected following the manufacturer's instructions to minimize infection risk.
The recall indicates a risk of inadequate disinfection, so users should verify the disinfection process and check if their model is affected before use.
Affected models include 11278VSA, 11278VSE, 11278VSU, 11278VSUA, and 11278VSUE with specific UDI codes and production dates from January 2018 onward.
The recall does not specify a return process, so users should check with Karl Storz directly for guidance on handling affected instruments.
We’ve drafted a message you can send Karl Storz to request your refund or repair — edit it as you like.
Subject: Recall Z-1069-2022 — Karl Storz Karl Storz Hello, I own a Karl Storz that is covered by recall Z-1069-2022 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.
