Karl Storz recalls flexible DCI intubation fiberscopes with part number 11301BND1 due to infection risk 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Karl Storz is recalling flexible DC: intubation fiberscopes with part number 11301BND1 because outdated sterilization methods could lead to infections. This affects medical devices used in hospitals and clinics.
Improper sterilization of these fiberscopes could allow infectious agents to enter patient airways. The recall specifically addresses two issues: using the wrong sterilization tray and avoiding ethylene oxide gas for certain models with long tubes.
Healthcare professionals using these fiberscopes in hospitals or clinics are most at risk. Patients receiving procedures with these devices could be exposed to infections if sterilization is not followed correctly.
Check for part number 11301BND1 on the fiberscope. The instruction manual version is 08/2018. These devices are used for upper airway exams and endotracheal tube placement in medical settings.
Review the instruction manual for version 08/2018 to ensure proper sterilization methods are followed.
The recall is due to updated sterilization instructions to prevent using certain trays and ethylene oxide gas on specific models, which could lead to infections.
Part number 11301BND1 on the fiberscope with instruction manual version 08/2018.
Patients could be exposed to infections if the fiberscope is not sterilized properly, but the recall is for healthcare 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-2894-2020 — Karl Storz Karl Storz Hello, I own a Karl Storz that is covered by recall Z-2894-2020 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.
