The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0421-2016·Announced 2015-12-23

Verathon GlideScope AVL Video Laryngoscope Blades Recalled for Separation Risk

Verathon is recalling GlideScope AVL video laryngoscope blades because silicone adhesive bonding may be inadequate, creating a risk of blade separation 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 involves a medical device with a risk of component separation during a critical procedure (intubation). Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Verathon, Inc. is recalling certain models and serial numbers of GlideScope AVL video laryngoscope blades. The recall is due to inadequate bonding of the silicone adhesive that affixes the halves of the blade, which may cause the blades to separate.

The potential for blade separation may not be readily visible during routine inspection before or after intubation. The affected units are distributed worldwide, including in the United States and internationally.

Healthcare providers should check their inventory against the specific serial numbers listed in the official recall notice. Users should stop using the affected blades and contact Verathon, Inc. for instructions on replacement or repair.

The recalled product

Product
GlideScope AVL Video Laryngoscope (AVL), Part Number AVL 3- 0574-0115; AVL 4-0574-0116, AVL 5- 0574-0117. AVL is a video laryngoscope that incorporates a high resolution color camera, an LED light source and video output to a remote monitor. This system has a digital…
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)

  • AD151509
  • AD151510
  • AD151511
  • AD151512
  • AD151514
  • AD151516
  • AD151517
  • AD151518
  • AD151519
  • AD151520
  • AD151521
  • AD151522
  • AD151523
  • AD151526
  • AE151507
  • AE151529
  • AE151542
  • AE151543
  • AE151544
  • AF151517

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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Same hazard · component separation

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