Agency classClass IIOur severity:High FDA (Devices)·Z-1618-2020·Announced 2020-04-08

Karl Storz C-MAC Video Laryngoscope Recall Due to Loose Glass Cover

Karl Storz is recalling 27,165 C-MAC Video Laryngoscopes because the glass cover at the distal end may become loose during use or reprocessing, potentially delaying procedures or requiring removal from the body.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device where a component may become loose during use, posing a risk of harm (procedure delay or need for removal) without reported injuries, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Karl Storz Endoscopy is recalling 27,165 C-MAC Video Laryngoscopes (MIL # 1) in the 8403xx and 8401xx series. The recall covers specific reference numbers including 8403AX, AXC, BX, BXC, DXC, EXC, GXC, HX, HXK, HXP, KXC, MXC, and 8401AX, AXC, BX, BXC, DXC, GXC, HX, HXP, KXC. These devices are used to visualize airways and vocal cords during endotracheal intubation and for examining the upper respiratory tract.

The recall was initiated because the glass cover at the distal end of the camera/LED lighting may become loose during reprocessing or use. If the cover becomes loose during a procedure, it may result in a delay in the procedure and/or require the device to be removed from the body. The source text does not report any injuries or illnesses associated with this defect.

The affected products were distributed worldwide, including nationwide in the United States and in Canada. Healthcare facilities and users should stop using the affected video laryngoscopes and contact Karl Storz Endoscopy for instructions on how to proceed.

The recalled product

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.…
Manufacturer: Karl Storz Endoscopy
Category: Medical Device — Endoscopy / Laryngoscopy
Hazard: loose-component
procedure-delay
Affected units: 27,165

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

All Lots

Distribution

Distributed nationwide across the United States.

Same manufacturer · Karl Storz Endoscopy

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Same hazard · loose component