Karl Storz recalls C-MAC Video Laryngoscope MIL #1 models 8403xx and 8401xx series due to potential loose glass cover during use, causing procedure delays. Affected users should contact Karl Storz for details.
The firm has become aware that there is a potential that the glass cover at the distal end of the camera/led lighting on the video laryngoscope could become loose during reprocessing or use. If this occurs during usage, it may result in a delay in procedure and/or require removal from body.
Karl Storz is recalling specific video laryngoscope models that may have a loose glass cover at the camera end. This could cause delays in medical procedures or require removal from the patient's body during use.
The glass cover at the camera/LED lighting end could become loose during reprocessing or use. If loose, it might delay the procedure or require the device to be removed from the patient's airway.
Medical professionals using the C-MAC Video Laryngoscope for intubation procedures are most at risk. Patients undergoing airway procedures with these devices may be affected.
Check for model numbers starting with 8403xx or 8401xx (e.g., 8403AX, 8401AX). These devices were sold with the C-MAC Video Laryngoscope MIL #1.
Identify the model number on your device, which should start with 8403xx or 8401xx.
Reach out to Karl Storz Endoscopy for specific instructions on whether your device needs repair or replacement.
The glass cover at the camera/LED lighting end could become loose during reprocessing or use, potentially delaying procedures or requiring removal from the patient's airway.
Models starting with 8403xx (e.g., 8403AX, AXC, BX) and 8401xx (e.g., 8401AX, AXC, BX).
No, but you should check the model number and contact Karl Storz for specific instructions.
We’ve drafted a message you can send Karl Storz Endoscopy to request your refund or repair — edit it as you like.
Subject: Recall Z-1618-2020 — Karl Storz Endoscopy Karl Storz Endoscopy Hello, I own a Karl Storz Endoscopy that is covered by recall Z-1618-2020 from Karl Storz Endoscopy. 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.
