Karl Storz recalls Slim Nasopharyngolaryngoscopes from 2018 with disinfection failure risk. Products may not reduce microorganisms as expected after cleaning.
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Karl Storz is recalling certain Slim Nasopharyngolaryngoscopes made from January 2018 due to a disinfection process that fails to achieve the required six-log reduction in microorganisms. This could lead to infections if the device is not properly cleaned.
The disinfection process does not reliably reduce microorganisms to the required level. This means the device may not be safe for use after cleaning, increasing infection risk during medical procedures.
Healthcare professionals and patients using the recalled devices for nasal or throat examinations. Those most at risk are individuals with compromised immune systems or those requiring frequent procedures.
Check for the model numbers 11001RD1 or 11001RDK1, serial numbers from January 2018 onward, and the UDI code 0408551225608. The product was sold with the label 'KARL STORZ Slim Nasopharyngolaryngoscope 96216006US V5.0 (10-2018).'
Look for the model numbers 11001RD1 or 11001RDK1, serial numbers from January 2018 onward, and the UDI code 0408551225608.
The disinfection process does not achieve the expected six-log reduction in microorganisms, which could lead to infections if the device is not properly cleaned.
Check for model numbers 11001RD1 or 11001RDK1, serial numbers from January 2018 onward, and the UDI code 0408551225608.
The recall does not specify a remedy, so contact Karl Storz directly for guidance.
We’ve drafted a message you can send Karl Storz to request your refund or repair — edit it as you like.
Subject: Recall Z-1054-2022 — Karl Storz Karl Storz Hello, I own a Karl Storz that is covered by recall Z-1054-2022 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.
