Class II — Verathon, Inc.
| Recalling firm | Verathon Inc. |
|---|---|
| Registered facility | Verathon Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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. |
| Quantity | total 9088 units ( 5786 units in the US and 3302 units International) |
| Distribution | Worldwide Distribution. |
| Initiated | 2015-04-13 |
| Classified | 2016-02-17 |
| Terminated | 2016-10-26 |
| Recall number | Z-0811-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Verathon, Inc. (Z-0811-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71008/
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