Karl Storz Endoscopy 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 tr Recall
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According to the U.S. Food and Drug Administration (FDA)
Product
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 tr
Brand
Karl Storz Endoscopy
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Karl Storz Endoscopy is recalling Karl Storz SE & Co. KG, C-MAC Video Laryngoscope MIL # 1, for the following REF numbers: 1. 8403x due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On 12/6/2019 a "Urgent Medical device Correction" letter was sent to affected customers via mail. In addition, to providing information on the recall, the firm asked customers to take the following actions: 1. Please forward this Safety Information to the appropriate departments in your organization. 2. Please train your employees on the new Instructions for Use, especially chapter 5.1. 3. Please complete the attached acknowledgement form and return it to us. 4. If you have any questions about this communication, or needs additional copies of this Instruction for Use, please contact our Technical Support at 800-421-0837, Ext. 5350, Option 5.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026