The Recall Desk
ModerateFDA (Devices)·Z-1035-2016·Announced 2016-03-16

Verathon Recalls GlideScope Titanium Video Laryngoscope Blades Due to Image Flickering

Verathon is recalling GlideScope Titanium single-use video laryngoscope blades because the video image may flicker or distort during use.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class I, which typically indicates a reasonable probability of serious adverse health consequences or death. However, the specific defect is a video image flicker, which is a functional defect rather than a direct physical hazard like a broken blade or contamination. The rubric places FDA Class I at a minimum of 4, but the specific nature of the defect (image quality) suggests a lower immediate physical risk compared to structural failures. Wait, the rubric says 'If the agency's own classification is FDA Class I... never go below 4.' Therefore, the score must be 4.

Plain-English summary

Verathon, Inc. is recalling the GlideScope Titanium Single-Use Video Laryngoscope blades. The recall involves 7,733 units, including 6,377 units in the United States and 1,356 units distributed internationally to countries including Australia, Belgium, Canada, Denmark, France, Germany, Hong Kong, Italy, Luxembourg, Saudi Arabia, Singapore, Spain, Sweden, The Netherlands, the U.A.E., and the United Kingdom.

The firm identified a potential for disruption, specifically flickering, in the video laryngoscopy image when the blades are in use. This video flickering appears as an intermittent break-up of the on-screen video image, manifesting as distorted horizontal or vertical bars of displaced video signal. The affected product is intended for use by qualified medical professionals to obtain a clear, unobstructed view of the vocal cords for medical procedures.

The affected part numbers include LoPro S3 (0574-0130, 0270-0769), LoPro S4 (0574-0131, 0270-0770), MAC S3 (0574-0132, 0270-0771), and MAC S4 (0574-0133, 0270-0772). The lot number ranges for these products are: LoPro S3 (081814 - 093015), LoPro S4 (081114 - 090315), MAC S3 (080814 - 101315), and MAC S4 (022514 - 082115).

The recalled product

Product
GlideScope Titanium Single-Use Video Laryngoscope. It is a single-use video laryngoscope system (GlideScope Titanium System) consists of a sterile-packaged, single-use video laryngoscope, multi-use Smart Cable and portable GlideScope video monitor. The system incorporates a h
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 (4)

  • LOT Number ranges: -LoPro S3: 081814 - 093015
  • -LoPro S4: 081114 - 090315
  • -MAC S3: 080814 - 101315
  • -MAC S4: 022514 - 082115

Distribution

Distributed nationwide across the United States.

Related recalls

Same manufacturer · Verathon, Inc.

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Same hazard · image distortion

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