Z-0811-2016Class II

GlideScope Video Laryngoscope Reusable Blades (GVL 3, 4, 5 and AVL 2, 3, 4, 5). GVL: The GlideScope Video...

Name: Z-0811-2016 GlideScope Video Laryngoscope Reusable Blades (GVL 3, 4, 5 and AVL 2, 3, 4, 5). GVL: The GlideScope Video...
Creator: Verathon, Inc.
Published: 2015-04-13
License: https://open.fda.gov/license/

Verathon Inc. / initiated 2015-04-13 / Terminated / root cause: manufacturing process

FDA source

Verathon, Inc. began a recall of 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... on 2015-04-13. FDA classified it as Class II and gives the reason as "Verathon has revised the Operations and Maintenance Manual (OMM) to specifically state compatibility limitations of the reusable video laryngoscope Blade validated through simulated use cycles, such that exceeding this...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0811-2016
Classification: Class II
Status: Terminated
Initiated: 2015-04-13
Posted: 2015-07-13
Terminated: 2016-10-26
Recalling firm: Verathon Inc.
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 monitor. It consists of a video laryngoscope and a portable video monitor. AVL: The GlideScope AVL Video Monitor system has the same intended use as the GVL System. The difference between systems is that the AVL has a digital platform and the GVL an analog platform.
Product code: CCW Laryngoscope, Rigid
Reason for recall: Verathon has revised the Operations and Maintenance Manual (OMM) to specifically state compatibility limitations of the reusable video laryngoscope Blade validated through simulated use cycles, such that exceeding this number of cycles in the specific chemical agent may affect the potential life of the product.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Verathon sent an Urgent Medical Device Safety Alert letter dated April 13, 2015 and Safety Alert Reply Form to their consignees on April 17, 2015 Users are informed that Verathon implemented a Safety Alert regarding updates to the following Operations and Maintenance Manuals (OMM): " GVL Operations and Maintenance Manual: 0900-1204-08-60 " AVL Operations and Maintenance Manual: 0900-4200-02-60 For a copy of the most recent GVL or AVL Operations and Maintenance Manual, please visit http://verathon.com/support. If you have any questions regarding the Operations and Maintenance Manuals revisions noted above, please contact your Verathon representative or Verathon Customer Care at 800.331.2313 or 425.867.1348. You may also email [email protected]. PLEASE NOTE: NO ADDITIONAL ACTIONS NEED TO BE TAKEN.
Quantity in commerce: total 9088 units ( 5786 units in the US and 3302 units International)
Distribution: Worldwide Distribution.
Product codes and lots: Affected GVL Reusable Blades Serial Numbers, by Part Number GVL 3- 0574-0007: MD131859- MD151622; GVL 4- 0574-0001: LG131994- LG151773; GVL 5- 0574-0030: XL131577- XL151524. Affected AVL Reusable Blades Serial Numbers, 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0811-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0811-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-24	2016-02-17

Product code CCW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)