Karl Storz recalls Model 11161C2 Flexible Neuroscopes due to incorrect sterilization instructions in the manual, risking unsterile reprocessing. Affected units include all lots.
During a complaint investigation it was determined that an error was observed within the instruction manual included with some scopes. Specifically, The Quick Connector Kits (QCK) and tray information, specified for the STERIS System 1E (SS1E) sterilization method within the instruction manual is incorrect. If the user uses SS1E to sterilize the impacted scopes and referred to the manual concerning the QCK information, the sterility of reprocessed scope cannot be guaranteed.
Karl Storz is recalling all Flexible Neuroscope models 11161C2 because the instruction manual contains errors about sterilization. This could lead to unsterile reprocessing if users follow the incorrect instructions.
The instruction manual incorrectly specifies sterilization steps for the Quick Connector Kits (QCK) and tray. If users follow these incorrect instructions using the STERIS System 1E, the scope may not be properly sterilized after reprocessing.
Medical professionals using the Karl Storz Flexible Neuroscope model 11161C2 are most at risk. Patients could be exposed to infection if the scope is reprocessed without proper sterilization.
Check for the model number 11161C2 on the product. All lots of this model are affected, so no specific lot numbers are needed.
Check the instruction manual for correct sterilization procedures for the Quick Connector Kits and tray.
The official recall notice does not provide a fix or remedy for this issue.
Check for the model number 11161C2 on the product. All lots of this model are affected.
The official recall notice does not specify any action steps for affected users.
We’ve drafted a message you can send Karl Storz to request your refund or repair — edit it as you like.
Subject: Recall Z-1531-2020 — Karl Storz Karl Storz Hello, I own a Karl Storz that is covered by recall Z-1531-2020 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.
