Karl Storz recalls flexible intubation fiberscopes with part number 11301BN1 due to infection risk from improper sterilization. Updated instructions prevent using certain trays and ethylene oxide gas.
Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used on certain reusable flexible intubation endoscopes with total lumen lengths greater than 850mm. Incompletely sterilized endoscopes might introduce infectious agents into patient airways, resulting in infection.
Karl Storz is recalling flexible intubation fiberscopes with part number 11301BN1 because improper sterilization could lead to infections. This affects medical devices used in hospitals and clinics for airway exams.
If the fiberscope is not sterilized properly, infectious agents could enter the patient's airway during medical procedures. The risk occurs when specific sterilization trays are used or ethylene oxide gas is applied to fiberscopes longer than 850mm.
Healthcare professionals using these fiberscopes in hospitals or clinics are most at risk. Patients receiving procedures with these devices could be exposed to infections if sterilization is not done correctly.
Check for part number 11301BN1 on the fiberscope or instruction manual version 08/2018. These devices are used for airway exams and endotracheal tube placement in medical settings.
Review the instruction manual for updated sterilization guidelines to avoid using specific trays or ethylene oxide gas on longer fiberscopes.
The recall is due to a risk of infection from improper sterilization, specifically when using certain trays or ethylene oxide gas on fiberscopes longer than 850mm.
Part number 11301BN1 with instruction manual version 08/2018.
Look for part number 11301BN1 on the fiberscope or the instruction manual version 08/2018.
We’ve drafted a message you can send Karl Storz to request your refund or repair — edit it as you like.
Subject: Recall Z-2892-2020 — Karl Storz Karl Storz Hello, I own a Karl Storz that is covered by recall Z-2892-2020 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.
