Use caution Medical device recall · FDA · Published December 6, 2019

Karl Storz C-MAC Video Laryngoscope Recall: Loose Glass Cover Risk

Karl Storz recalls C-MAC Video Laryngoscope MIL #1 models 8403xx and 8401xx series due to potential loose glass cover during use, causing procedure delays. Affected users should contact Karl Storz for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1618-2020Medical device Karl Storz Endoscopy ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmKarl Storz Endoscopy2151 E Grand Ave · El Segundo, CA 90245-5017

✎ GovInfoNow plain-language explainer

Karl Storz is recalling specific video laryngoscope models that may have a loose glass cover at the camera end. This could cause delays in medical procedures or require removal from the patient's body during use. Read more at govinfonow.com/recall/66398-karl-storz-c-mac-video-laryngoscope-recall-loose-glass-cover.

Source Summary by GovInfoNow · govinfonow.com/recall/66398-karl-storz-c-mac-video-laryngoscope-recall-loose-glass-cover · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1618-2020

Cite this page

“Karl Storz C-MAC Video Laryngoscope Recall: Loose Glass Cover Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66398-karl-storz-c-mac-video-laryngoscope-recall-loose-glass-cover. Based on FDA recall #Z-1618-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1618-2020%22&limit=1).

The FDA announced on 2019-12-06 that Karl Storz Endoscopy is recalling C-MAC Video Laryngoscopes because the glass cover at the distal end may become loose during use. This defect could delay procedures or require removal from the body.

How to tell if you have it

Brand: Karl Storz Endoscopy
Product: C-MAC Video Laryngoscope MIL # 1
REF numbers: 8403xx series (including 8403AX, AXC, BX, BXC, DXC, EXC, GXC, HX, HXK, HXP, KXC, MXC) and 8401xx series (including 8401AX, AXC, BX, BXC, DXC, GXC, HX, HXP, KXC)
Lots: All Lots
Quantity: 27,165 scopes

The hazard

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, it may result in a delay in procedure and/or require removal from body.

Context

GovInfoNow's records show Karl Storz Endoscopy has had 24 other recalls since 2017-10-10. Recent brand recalls include the Karl Storz HOPKINS Telescope Recall on 2026-08-12 for incorrect eyepiece packaging labels and the Karl Storz Flexible Hystero-Fiberscope Kits recall on 2026-05-21 involving expired sterility seal risks. Other recent recalls of similar products include the Wilson-Cook Instinct Plus Endoscopic Clipping Device Recall (2026-03-03) and the Canon Alphenix X-ray Systems Recall (2026-08-04).

How to tell if you have this one

Check for model numbers starting with 8403xx or 8401xx (e.g., 8403AX, 8401AX). These devices were sold with the C-MAC Video Laryngoscope MIL #1.

Brand
Karl Storz Endoscopy
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Model
Identify the model number on your device, which should start with 8403xx or 8401xx.
Contact Karl Storz
Reach out to Karl Storz Endoscopy for specific instructions on whether your device needs repair or replacement.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide and country of Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 2.6 years after the firm started it.

Dec 6, 2019Firm started the recall
Mar 31, 2020FDA classified it Class II
Apr 8, 2020Published in FDA’s Enforcement Report
Jul 1, 2022FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/66398-karl-storz-c-mac-video-laryngoscope-recall-loose-glass-cover">Karl Storz C-MAC Video Laryngoscope Recall: Loose Glass Cover Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1618-2020 (December 6, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1618-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.