Karl Storz recalls specific ureteroscope models due to failure to reduce microorganisms during disinfection. Affected units may not be safe for medical use after cleaning.
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Karl Storz is recalling certain ureteroscope models because they don't properly reduce microorganisms after disinfection. This could lead to infections if used without proper cleaning. Patients and healthcare providers should check their equipment against the listed serial numbers.
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.
Healthcare providers and medical facilities that own or use the recalled ureteroscopes. Patients using these devices during procedures are at risk if the equipment isn't properly disinfected.
Check for the model numbers: 11278V, 11278VK, 11278VA, 11278VAK, 11278VU, 11278VUK, 11278VUA, 11278VUAK. Units manufactured since January 2018 are affected. Look for the UDI codes listed in the recall notice.
Identify if your ureteroscope matches the model numbers and production dates listed in the recall notice.
The recall states that these models may not achieve the required six-log reduction in microorganisms after disinfection, so they are not safe for medical use without proper cleaning.
Check the model numbers and production dates against the list provided in the recall notice. Units manufactured since January 2018 are affected.
The recall does not specify a remedy, so you should contact Karl Storz Endoscopy directly for guidance on safe handling 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-1068-2022 — Karl Storz Karl Storz Hello, I own a Karl Storz that is covered by recall Z-1068-2022 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.
