Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Karl Storz SE & Co. KG Recalled by Karl Storz Endoscopy Due to The firm has become aware that there is...

Date: December 6, 2019
Company: Karl Storz Endoscopy
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Karl Storz Endoscopy directly.

Affected Products

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.

Quantity: 27,165 scopes

Why Was This 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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Karl Storz Endoscopy

Karl Storz Endoscopy has 70 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report