Karl Storz recalls certain flexible ureteroscopes that may not achieve required disinfection, risking infection during medical procedures. Affected models include 11278VSA, 11278VSE, 11278VSU, and 11278VSUA/VSUE with specific serial dates.
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Karl Storz is recalling specific flexible ureteroscopes that may not disinfect properly, potentially leading to infections during medical procedures. Patients using these devices should contact the manufacturer for details on affected models and next steps.
The devices may not achieve the required six-log reduction in microorganisms after disinfection. This means they could remain contaminated with harmful bacteria, increasing infection risk during medical procedures.
Medical professionals using the recalled ureteroscopes are most at risk. Patients using these devices for procedures may be affected if they have a recent procedure with the recalled model.
Check for model numbers 11278VSA, 11278VSE, 11278VSU, or 11278VSUA/VSUE with serial dates from January 2018 onward. The UDI codes listed in the recall notice may also help identify affected units.
Identify your ureteroscope model by checking the product label for the model number (e.g., 11278VSA).
Reach out to Karl Storz Endoscopy for assistance with identifying affected units and next steps.
The recall affects 11278VSA, 11278VSE, 11278VSU, and 11278VSUA/VSUE models manufactured since January 2018.
Check the model number on your device and the serial date. Affected units were manufactured from January 2018 onward with specific UDI codes listed in the recall notice.
The recall does not require immediate discontinuation; medical professionals should contact Karl Storz for guidance on affected units.
We’ve drafted a message you can send Karl Storz to request your refund or repair — edit it as you like.
Subject: Recall Z-1070-2022 — Karl Storz Karl Storz Hello, I own a Karl Storz that is covered by recall Z-1070-2022 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.
