Karl Storz recalls flexible intubation fiberscopes with model 11302BD2 that may not be properly sterilized, risking patient infections if not handled correctly.
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 model number 11302BD2 due to a risk of incomplete sterilization. This could lead to infectious agents entering patient airways during medical procedures.
The fiberscopes may not be sterilized correctly if the wrong tray is used or ethylene oxide is applied to models longer than 850mm. This can introduce infections into the patient's airways during medical procedures.
Healthcare professionals using the fiberscope for medical procedures are most at risk. Patients undergoing intubation procedures may be affected if the device is not properly sterilized.
Check for the model number 11302BD2 on the fiberscope and the instruction manual version 08/2018. The product is used for examining the upper airway and placing endotracheal tubes.
Check the instruction manual for updated sterilization procedures to avoid using the wrong tray or ethylene oxide for certain models.
The model number is 11302BD2.
The recall is due to a risk of incomplete sterilization, which could introduce infectious agents into patient airways.
Patients undergoing intubation procedures may be at risk of infection if the fiberscope is not properly sterilized.
We’ve drafted a message you can send Karl Storz to request your refund or repair — edit it as you like.
Subject: Recall Z-2893-2020 — Karl Storz Karl Storz Hello, I own a Karl Storz that is covered by recall Z-2893-2020 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.
