Karl Storz recalls specific flexible ureteroscope models from 2016-2018 due to failure to reduce microorganisms during 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 certain flexible ureteroscopes that may not properly reduce microorganisms after disinfection. This could lead to infections during medical procedures if the instruments are reused without adequate cleaning.
The ureteroscopes may not achieve the required six-log reduction in microorganisms after disinfection. This means harmful bacteria could survive and potentially cause infections during medical procedures if the instruments are reused without proper cleaning.
Healthcare professionals using the recalled ureteroscopes for medical procedures are most at risk. Patients undergoing procedures with these instruments could face infection risks.
Check for model numbers: 11278A2, 11278AC1, 11278AC2, 11278ACU1, or 11278AU1. These were manufactured from January 2018 onward. The UDI codes listed in the recall notice also identify affected units.
Identify the model number on your ureteroscope to see if it matches the recalled series (11278A2, 11278AC1, etc.).
Reach out to Karl Storz Endoscopy directly for further guidance on the recall and potential remedies.
The recall occurs because the ureteroscopes may not achieve the required six-log reduction in microorganisms after disinfection, increasing infection risks during medical procedures.
Check for model numbers 11278A2, 11278AC1, 11278AC2, 11278ACU1, or 11278AU1, which were manufactured from January 2018 onward. The UDI codes listed in the recall also identify affected units.
Contact Karl Storz Endoscopy directly for guidance on the recall and potential remedies.
We’ve drafted a message you can send Karl Storz to request your refund or repair — edit it as you like.
Subject: Recall Z-1067-2022 — Karl Storz Karl Storz Hello, I own a Karl Storz that is covered by recall Z-1067-2022 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.
