Karl Storz recalls flexible DCI intubation fiberscopes with model 11302BDD2 due to risk of infection 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 DCI intubation fiberscopes with model number 11302BDD2 because improper sterilization could lead to infections. This affects medical devices used in hospitals and clinics for airway exams and tube placement.
The fiberscopes have a risk of infection if not sterilized properly. Incomplete sterilization could introduce infectious agents into patient airways during medical procedures.
Healthcare professionals using the fiberscopes in hospitals or clinics are most at risk. Patients receiving procedures with these devices may be exposed to infection if sterilization is not done correctly.
Check for model number 11302BDD2 on the fiberscope. The instruction manual version is 08/2018. These devices are used for airway exams and endotracheal tube placement in medical settings.
Review the updated sterilization instructions to ensure you are not using a specific tray or ethylene oxide gas for these devices.
The recall is due to a risk of infection from improper sterilization of the fiberscopes, which could introduce infectious agents into patient airways.
Model number 11302BDD2 with instruction manual version 08/2018.
Look for the model number 11302BDD2 on the fiberscope and 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-2895-2020 — Karl Storz Karl Storz Hello, I own a Karl Storz that is covered by recall Z-2895-2020 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.