Karl Storz recalls flexible intubation endoscopes with model 11301BNX that may not be properly sterilized, risking patient infection if ethylene oxide is used on certain models.
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 11301BNX due to a risk of infection from improper sterilization. If these endoscopes are not sterilized correctly, they could introduce infectious agents into patients' airways.
The endoscope may not be properly sterilized if ethylene oxide is used on models longer than 850mm or if the wrong sterilization tray is used. This can introduce infectious agents into the patient's airways, potentially causing infections.
Healthcare professionals using the endoscope for patient airways are most at risk if improper sterilization occurs. Patients receiving procedures with this endoscope could be exposed to infections.
Check for model number 11301BNX on the endoscope. The instruction manual version is 01/2020. This product was sold for medical use in the U.S.
Review the instruction manual for version 01/2020 to ensure proper sterilization methods are followed.
The endoscope is safe if sterilized correctly using the updated instructions. Improper sterilization could lead to infection.
The model number is 11301BNX.
The recall does not require returning the endoscope; healthcare providers should follow updated sterilization instructions.
We’ve drafted a message you can send Karl Storz to request your refund or repair — edit it as you like.
Subject: Recall Z-2891-2020 — Karl Storz Karl Storz Hello, I own a Karl Storz that is covered by recall Z-2891-2020 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.
