The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1558-2013·Announced 2013-06-26

Verathon Recalls GlideScope Reusable Laryngoscope Blades Due to Breakage Risk

Verathon is recalling GlideScope reusable laryngoscope blades because the tips may break prematurely without visible signs, posing a risk to patients during intubation.

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: "Verathon GlideScope Reusable GVL and AVL Blades are being recalled due to the potential risk of premature failure/breakage of the blade tip that may not be readily visible during routine inspection before or after intubation."

Plain-English summary

Verathon, Inc. is recalling GlideScope Video Laryngoscope (GVL) 3, 4, and 5 and GlideScope (AVL) 2, 3, 4, and 5 reusable blades. The recall involves 4,784 units worldwide, including 3,381 in the United States and 1,403 internationally. The devices are intended for use by qualified medical professionals to obtain a clear view of the vocal cords during medical procedures.

The recall is due to the potential risk of premature failure or breakage of the blade tip. This breakage may not be readily visible during routine inspection before or after intubation. The source text does not report any specific injuries, illnesses, or deaths associated with this defect.

The affected products were distributed nationwide in the United States and in numerous international countries, including Argentina, Australia, Brazil, Canada, China, and others. Medical professionals should stop using the affected blades and contact Verathon for instructions on how to return or replace the devices.

The recalled product

Product
GlideScope Video Laryngoscope (GVL) 3, 4, 5 and GlideScope (AVL) 2, 3, 4 and 5 reusable blades Product Usage: The GlideScope Video Laryngoscopes are intended for use by qualified medical professionals to obtain a clear, unobstructed view of the vocal cords for medical…
Manufacturer
Verathon, Inc.
Category
Medical Device — Surgical Instruments
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 (10)

  • Model
  • Part and Serial Numbers: Model # GVL 3
  • Part # 0574-0007
  • Serial # range MD112388 to MD121908
  • Model # GVL 4 Part # 0574-0001 Serial # range LG112759 to LG122582
  • Model # GVL 5 Part # 0574-0030 Serial # range XL111799 to XL121759
  • Model # AVL 2 Part # 0574-0118 Serial # range AC111500 to AC121604
  • Model # AVL 3 Part # 0574-0115 Serial # range AD111500 to AD121688
  • Model # AVL 4 Part # 0574-0116 Serial # range AE11150 to AE121778
  • and Model # AVL 5 Part # 0574-0117 Serial # range AF111500 to AF121666.

Distribution

Distributed nationwide across the United States.

The notice also names 49 states specifically:

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