FDA Device recall Z-0811-2016
GlideScope Video Laryngoscope Reusable Blades (GVL 3, 4, 5 and AVL 2, 3, 4, 5)
- FDA Device
- Class II
- terminated
- Published 2016-02-24
On 2016-02-24 the FDA classified a Class II recall of GlideScope Video Laryngoscope Reusable Blades (GVL 3, 4, 5 and AVL 2, 3, 4, 5) by Verathon, citing verathon has revised the Operations and Maintenance Manual (OMM) to specifically state compatibility limitations of the reusable video laryngoscope Blade validated through simulat….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0811-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-04-13 |
| Published | 2016-02-24 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Verathon |
| Distribution | n/a |
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.
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.
Identifiers
| code_info | Affected GVL Reusable Blades Serial Numbers, by Part Number GVL 3- 0574-0007: MD131859- MD151622; GVL 4- 0574-0001:…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Other recalls by Verathon
- Brand Name: GlideScope Core 15-inch FHD Model/Catalog Number: 0570-0437 Software Version: Core 15 FHD v1.7 and earlier Product Description:…
FDA Device · Class II · 2024-06-12 · Verathon - Brand Name: GlideScope Core 15-inch Monitor Model/Catalog Number: 0570-0404 Product Description: Serialized Monitor
FDA Device · Class II · 2024-06-12 · Verathon - GlideScope Go Monitors
FDA Device · Class III · 2021-08-11 · Verathon - BladderScan Prime Plus Probe REF 0570-0395 - Product Usage: intended to be used for measuring the urine volume in the bladder noninvasively
FDA Device · Class II · 2020-12-09 · Verathon - GlideScope Core OneTouch Smart Cable, REF: 0800 0601, an accessory to the GlideScope Video Laryngoscope System Per PLRA: The Core OneTouch…
FDA Device · Class I · 2020-07-15 · Verathon
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0811-2016%22
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