FDA Device recall Z-1035-2016
GlideScope Titanium Single-Use Video Laryngoscope
- FDA Device
- Class I
- terminated
- Published 2016-03-16
On 2016-03-16 the FDA classified a Class I recall of GlideScope Titanium Single-Use Video Laryngoscope by Verathon, citing the firm has become aware of the potential for disruption (flickering) in the video laryngoscopy image when GlideScope Titanium SU laryngoscope blades are in use. Video "flickerin….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1035-2016 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2016-01-29 |
| Published | 2016-03-16 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Verathon |
| Distribution | US |
Product
GlideScope Titanium Single-Use Video Laryngoscope. It is a single-use video laryngoscope system (GlideScope Titanium System) consists of a sterile-packaged, single-use video laryngoscope, multi-use Smart Cable and portable GlideScope video monitor. The system incorporates a high-resolution, full-color digital camera and monitor for real-time viewing and recording. Affected Product Names and Part Numbers: -LoPro S3: 0574-0130 (single blade) or 0270-0769 (box of 10) -LoPro S4: 0574-0131 (single blade) or 0270-0770 (box of 10) -MAC S3: 0574-0132 (single blade) or 0270-0771 (box of 10) -MAC S4: 0574-0133 (single blade) or 0270-0772 (box of 10) The GlideScope Video Laryngoscopes are intended for use by qualified medical professionals to obtain a clear, unobstructed view of the vocal cords for medical procedures.
Reason
The firm has become aware of the potential for disruption (flickering) in the video laryngoscopy image when GlideScope Titanium SU laryngoscope blades are in use. Video "flickering" appears as the intermittent break-up of the on-screen video image, appearing as either distorted horizontal or vertical bars of displaced video signal.
Identifiers
| code_info | LOT Number ranges: -LoPro S3: 081814 - 093015; -LoPro S4: 081114 - 090315; -MAC S3: 080814 - 101315; -MAC S4: 022514 - 082115; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1035-2016%22
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