Karl Storz Endoscopy: Medical Device Recall in 2020 - (Recall #: Z-1618-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: December 6, 2019

Date Posted: April 8, 2020

Recall Number: Z-1618-2020

Event ID: 85089

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.

Status: Terminated

Product Quantity: 27,165 scopes

Code Information:

All Lots

Distribution Pattern:

Worldwide distribution - US Nationwide and country of Canada.

Voluntary or Mandated:

Voluntary: Firm initiated