Karl Storz recalls flexible intubation endoscopes with model 1130:11303BNX 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 11303BNX due to risks of infection from improper sterilization. If these endoscopes are not sterilized correctly, they could introduce infectious agents into a patient's airway during medical procedures.
The endoscopes have a specific lumen length greater than 850mm that requires special sterilization. Using ethylene oxide or incorrect trays can lead to incomplete sterilization, allowing infectious agents to enter the patient's airway.
Healthcare professionals using the recalled endoscopes for airway examinations and endotracheal tube placement are most at risk. Patients undergoing procedures with these endoscopes could face infection if sterilization is incomplete.
Check for the model number 11303BNX on the endoscope or its instruction manual. The instruction manual version is listed as 01/2020.
Review the instruction manual for version 01/2020 to ensure proper sterilization procedures are followed.
The recall is due to risks of infection from improper sterilization, specifically if ethylene oxide is used on certain models with lumen lengths over 850mm.
The affected model is 11303BNX with instruction manual version 01/2020.
Look for the model number 11303BNX on the endoscope or its instruction manual, which is 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-2897-2020 — Karl Storz Karl Storz Hello, I own a Karl Storz that is covered by recall Z-2897-2020 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.
