Z-1618-2020Class II

Karl Storz SE & Co. KG, C-MAC Video Laryngoscope MIL # 1, for the following REF numbers: 1. 8403xx series...

Name: Z-1618-2020 Karl Storz SE & Co. KG, C-MAC Video Laryngoscope MIL # 1, for the following REF numbers: 1. 8403xx series...
Creator: Karl Storz Endoscopy
Published: 2019-12-06
License: https://open.fda.gov/license/

Karl Storz Endoscopy-America, Inc. / initiated 2019-12-06 / Terminated / root cause: labeling and UDI

FDA source

Karl Storz Endoscopy began a recall of 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... on 2019-12-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1618-2020
Classification: Class II
Status: Terminated
Initiated: 2019-12-06
Posted: 2020-03-31
Terminated: 2022-07-01
Recalling firm: Karl Storz Endoscopy-America, Inc.
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 transient use in invasive procedures through a body orifice.
Product code: EQN Laryngoscope, Nasopharyngoscope
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: 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.
Quantity in commerce: 27,165 scopes
Distribution: Worldwide distribution - US Nationwide and country of Canada.
Product codes and lots: All Lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1618-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1618-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-08	2020-03-31

Product code EQN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)