The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0478-2013·Announced 2012-12-19

Verathon Recalls GlideScope Video Laryngoscopes Due to Blade Cracking

Verathon is recalling GlideScope GVL3, GVL4, and GVL5 video laryngoscopes because their reusable blades may crack.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Re-usable video laryngoscope blades of the GlideScope GVL3, GVL4, and GVL5 were recalled due to potential cracking."

Plain-English summary

Verathon, Inc. is recalling the GlideScope Video Laryngoscope (GVL) models GVL3, GVL4, and GVL5. The recall involves a total of 2,710 units distributed worldwide, including the United States and various international markets. The affected devices are intended for use by qualified medical professionals to obtain a clear view of the vocal cords during medical procedures.

The recall was initiated due to a potential defect where the re-usable video laryngoscope blades may crack. The source text does not report any specific injuries, illnesses, or deaths associated with this defect.

Healthcare facilities and users should identify affected units by checking the serial number ranges provided in the official recall notice. Users should stop using the affected devices and contact Verathon, Inc. for instructions on how to proceed.

The recalled product

Product
The GlideScope Video Laryngoscope (GVL) is a video laryngoscope that incorporates a high-resolution color camera, an LED light source, a rechargeable lithium battery, and video output to a remote monitor. It consists of a video laryngoscope and a portable video monitor. The…
Manufacturer
Verathon, Inc.
Category
Medical Device — Surgical / Anesthesia Equipment
Hazard
Affected units
2,710

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 (3)

  • Serial numbers range for GVL3: 0574-0007/ MD105000 to MD112387
  • Serial numbers range for GVL4: 0574-0001/ LG105000 to LG112758
  • Serial numbers range for GVL5: 0574-0030/ XL105000 to XL111798.

Distribution

Distributed nationwide across the United States.

The notice also names 46 states specifically:

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