CLASS II Device recall · Reported 8 Apr 2020 · FDA Enforcement Report
Karl Storz SE & Co. KG, C-mac Video Laryngoscope MIL # recalled
Karl Storz Endoscopy is recalling Karl Storz SE & Co. KG, C-mac Video Laryngoscope MIL # 1, for the following, distributed nationwide in the US. The recall was initiated on 6 Dec 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1618-2020
- FDA event ID
- 85089
- Recalling firm
- Karl Storz Endoscopy, El Segundo, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Dec 2019
- FDA classified
- 31 Mar 2020
- Reported
- 8 Apr 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- CPAP & Ventilators
Timeline
| 6 Dec 2019 | Recall initiated by company | |
| 31 Mar 2020 | Classified by FDA | +116 days |
| 8 Apr 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Karl Storz SE & Co. KG, C-MAC Video Laryngoscope MIL # 1, for the following REF numbers: 1. 8403xx series, which includes: 8403AX, AXC, BX, BXC, DXC, EXC, GXC, HX, HXK, HXP, KXC, MXC 2. 8401xx series, which includes: 8401AX, AXC, BX, BXC, DXC, GXC, HX, HXP, KXC. Product Usage: Video Laryngoscopes are used to visualize the airways and vocal cords during endotracheal intubation and for the inspection and examination of the upper respiratory tract. Video Laryngoscopes are designed for transient use in invasive procedures through a body orifice.
Where it was distributed
Worldwide distribution - US Nationwide and country of Canada.
Questions about this recall
Is Karl Storz SE & Co. KG, C-mac Video Laryngoscope MIL # 1, for the following recalled?
Yes. Karl Storz Endoscopy recalled Karl Storz SE & Co. KG, C-mac Video Laryngoscope MIL # 1, for the following on 6 Dec 2019. The recall is Class II and its status is Terminated. Recall number Z-1618-2020.
Why was it recalled?
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.
Which lots are affected?
All Lots
Where was it sold?
Worldwide distribution - US Nationwide and country of Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
| Device | CLASS II | Flexible Hystero-Fiberscope Kits recalled by Karl Storz Endoscopy | Karl Storz Endoscopy | Sterility | Nationwide |
| Device | CLASS II | Karl Storz - Endoskope recalled | Karl Storz Endoscopy | Sterility | Nationwide |
| Device | CLASS II | Karl Storz - Endoskope recalled | Karl Storz Endoscopy | Sterility | Nationwide |
| Device | CLASS II | Karl Storz - Endoskope recalled | Karl Storz Endoscopy | Other | Nationwide |
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