Karl Storz recalls flexible pediatric neuroscopes with incorrect sterilization instructions that could lead to contamination if used with SS1E method. Affected models include 11282BN1.
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 flexible pediatric neuroscopes with model number 11282BN1 due to incorrect sterilization instructions in the manual. This could lead to contamination if users follow the wrong sterilization method.
The instruction manual contains incorrect information about the Quick Connector Kits (QCK) for the STERIS System 1E sterilization method. If users follow these instructions, the neuroscope may not be sterile after reprocessing, potentially causing contamination.
Healthcare professionals using the Karl Storz NEURO-FIBERSCOPE model 1128:2BN1 for pediatric neurosurgery. The risk is highest for those who follow the incorrect sterilization instructions.
Check for the model number 11282BN1 on the neuroscope. The recall applies to all lots of this model.
Check the manual for correct sterilization procedures for the STERIS System 1E method.
The product is safe if users follow the correct sterilization instructions as specified in the updated manual.
The official recall notice does not specify a remedy or action steps beyond reviewing the sterilization instructions.
Check for the model number 11282BN1 on the neuroscope. The recall applies to all lots of this model.
We’ve drafted a message you can send Karl Storz to request your refund or repair — edit it as you like.
Subject: Recall Z-1530-2020 — Karl Storz Karl Storz Hello, I own a Karl Storz that is covered by recall Z-1530-2020 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.
