Karl Storz recalls flexible intubation fiberscopes with part number 11301AA1 due to risk of infection from incomplete sterilization. Updated instructions prevent using certain sterilization 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 11301AA1 because improper sterilization could lead to infections in patients. This affects medical devices used during airway examinations and endotracheal tube placement.
The fiberscopes have a risk of infection if not properly sterilized. Incomplete sterilization could introduce infectious agents into patient airways, especially when using certain sterilization trays or ethylene oxide gas for devices longer than 850mm.
Healthcare professionals using the fiberscopes for airway examinations and endotracheal tube placement are most at risk. Patients receiving procedures with these devices may face infection if sterilization is incomplete.
Check for part number 11301AA1 on the fiberscope and instruction manual version 08/2018. These devices are used for airway examinations and endotracheal tube placement in medical settings.
Check the updated instructions for proper sterilization methods to avoid using specific trays or ethylene oxide gas on devices over 850mm.
The recall is due to a risk of infection from incomplete sterilization of the fiberscopes, which could introduce infectious agents into patient airways.
The affected part number is 11301AA1 with instruction manual version 08/2018.
Look for part number 11301AA1 on the fiberscope and instruction manual version 08/2018. These devices are used for airway examinations and endotracheal tube placement in medical settings.
We’ve drafted a message you can send Karl Storz to request your refund or repair — edit it as you like.
Subject: Recall Z-2890-2020 — Karl Storz Karl Storz Hello, I own a Karl Storz that is covered by recall Z-2890-2020 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.
