Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0811-2016·Announced 2016-02-24

Verathon Recalls GlideScope Video Laryngoscope Blades for Manual Revision

Verathon is recalling GlideScope and AVL video laryngoscope reusable blades to update the Operations and Maintenance Manual regarding chemical cleaning cycle limits.

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 2/5 (Moderate).

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 II. The source text describes a manual revision to clarify maintenance limits, which aligns with the rubric's criteria for moderate severity involving labeling or documentation issues without reported injuries.

Plain-English summary

Verathon, Inc. is recalling 9,088 units of GlideScope Video Laryngoscope Reusable Blades (GVL 3, 4, 5 and AVL 2, 3, 4, 5). The recall affects 5,786 units in the United States and 3,302 units internationally. The specific serial numbers affected are listed in the agency's structured data.

The recall was initiated because Verathon revised the Operations and Maintenance Manual (OMM) to explicitly state compatibility limitations for the reusable blades. The revision clarifies that exceeding the validated number of simulated use cycles with specific chemical agents may affect the potential life of the product. This is a documentation and labeling update to ensure users are aware of these specific maintenance constraints.

Healthcare facilities and users should check their inventory for the affected serial numbers. The recall is intended to ensure that the updated manual information is available to users to prevent potential product degradation from exceeding validated cleaning cycles.

The recalled product

Product: GlideScope Video Laryngoscope Reusable Blades (GVL 3, 4, 5 and AVL 2, 3, 4, 5). GVL: The GlideScope Video Laryngoscope 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…
Manufacturer: Verathon, Inc.
Category: Medical Device — Surgical Instruments
Hazard: mis-labeling

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 (7)

Affected GVL Reusable Blades Serial Numbers
by Part Number GVL 3- 0574-0007: MD131859- MD151622
GVL 4- 0574-0001: LG131994- LG151773
by Part Numbers: AVL 2- 0574-0118: AC131852- AC151510
AVL 3- 0574-0115: AD131589- AD151506
AVL 4- 0574-0116: AE131586- AE151558
AVL 5- 0574-0117: AF131503- AF151500.

Distribution

Distribution scope not specified by the agency.

Same manufacturer · Verathon, Inc.

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