The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0420-2016·Announced 2015-12-23

Verathon GlideScope Video Laryngoscope Blades Recalled for Potential Separation

Verathon is recalling GlideScope Video Laryngoscope blades because silicone adhesive may fail, causing the blade halves to separate during use.

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 is classified as FDA Class II. The hazard involves a structural defect in a medical device used for intubation that could lead to injury, but the source text does not report any specific injuries or fatalities, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Verathon, Inc. is recalling specific models and serial numbers of GlideScope Video Laryngoscope (GVL) and AVL laryngoscope blades. The recall involves 612 units, with 394 units distributed in the United States and 218 units distributed internationally. The affected devices are intended for use by qualified medical professionals to obtain a clear view of the vocal cords for medical procedures.

The recall is due to a defect where the silicone adhesive affixing the halves of the blade may be inadequately bonded. This can cause the blade to separate. The source notes that the potential for blade separation may not be readily visible during routine inspection before or after intubation.

Healthcare facilities and users should check their inventory against the list of affected serial numbers provided in the official recall notice. If a device is affected, it should be removed from service and returned to Verathon, Inc. according to the company's instructions.

The recalled product

Product
GlideScope Video Laryngoscope (GVL), Part Number GVL 3 - 0574-0007; GVL 4 - 0574-0001; GVL 5- 0574-0030. The system consists of a video laryngoscope and portable video monitor. The GlideScope Video Laryngoscopes are intended for use by qualified medical professionals to obtain…
Manufacturer
Verathon, Inc.
Category
Medical Device — Laryngoscope
Hazard

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 (20)

  • LG152083
  • LG152084
  • LG152180
  • LG152181
  • LG152183
  • LG152184
  • LG152185
  • LG152186
  • LG152187
  • LG152188
  • LG152189
  • LG152191
  • LG152192
  • LG152193
  • LG152194
  • LG152195
  • LG152196
  • LG152197
  • LG152198
  • LG152199

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Verathon, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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