Device recall: GlideScope Video Laryngoscope (GVL), Part Number GVL 3 - 0574-0007; GVL 4 - 0574-0001; GVL 5- 0574-0030. The system…
Class II FDA enforcement event 72642. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Certain models and serial numbers of GlideScope GVL and AVL laryngoscope blades may separate, due to inadequate bonding of the silicone adhesive affixing the halves of the blade. The potential for blade separation may not be readily visible during routine inspection before or after intubation.
Class II, in the words of FDA
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
Verathon, Inc. started this device recall on 30 Nov 2015. The firm address in the FDA record is in Bothell, WA. FDA put the recall in Class II. FDA event 72642 has 2 product records. The first FDA enforcement report date is 23 Dec 2015. The record gives the status Terminated, with the termination date 22 Aug 2016.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide Distribution - US (nationwide including Puerto Rico) and Internationally to Bahrain, Belgium, Bermuda, Brunei Darussalam, Bulgaria, Canada, China , Czech Republic, Denmark, France,…
Recalling firm
Verathon, Inc., Bothell, WA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
2 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0420-2016 | 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 a clear, unobstructed view of the vocal… | total 612 units (394 units in the US and 218 units outside the US) | Class II | Terminated | 23 Dec 2015 |
| Z-0421-2016 | 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 platform. | 448 units (189 units in US and 259 units outside US) | Class II | Terminated | 23 Dec 2015 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2015
- 1,153
- Share of these events in Class II
- 91%
- Product records in this event
- 2Median of the firm: 1
- Events of the firm on the register
- 12
Other events of the firm
Official channels
- FDA enforcement report Z-0420-2016The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 72642. https://recallregister.com/fda/ii/72642/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide Distribution - US (nationwide including Puerto Rico) and Internationally to Bahrain, Belgium, Bermuda, Brunei Darussalam, Bulgaria, Canada, China , Czech Republic, Denmark, France,…
- What quantity of product is in FDA event 72642?
- The event has 2 product records. The first record gives this quantity:
total 612 units (394 units in the US and 218 units outside the US)
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2015 have the same class?
- 91% of the 1,153 device events that started in 2015 are in Class II.