Karl Storz recalls flexible intubation endoscopes with model 11302BDX that may not be sterilized properly, risking patient infections. Owners should check if their device has the specified model and follow official instructions.
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 video endoscopes with model number 11302BDX due to a risk of improper sterilization. This could lead to infectious agents entering patient airways during medical procedures.
The endoscope 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 endoscope for patient airways. Patients receiving procedures with this device are at risk if the endoscope is not properly sterilized.
Check for model number 11302BDX on the endoscope. The instruction manual version is 01/2020. This product is used for examining upper airways and placing endotracheal tubes.
Look for model number 11302BDX on the endoscope.
Ensure the endoscope is not sterilized using ethylene oxide for models longer than 850mm and that the correct sterilization tray is used.
The recall is due to a risk of improper sterilization, which could introduce infectious agents into patient airways during medical procedures.
Model number 11302BDX with instruction manual version 01/2020.
Check for model number 11302BDX on the endoscope and instruction manual version 01/2020.
We’ve drafted a message you can send Karl Storz to request your refund or repair — edit it as you like.
Subject: Recall Z-2896-2020 — Karl Storz Karl Storz Hello, I own a Karl Storz that is covered by recall Z-2896-2020 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.
