GlideScope Titanium Single-Use Video Laryngoscope — Class I medical device recall Z-1035-2016
Terminated recall by Verathon, Inc., reported 2016-03-16, distributed nationwide. The firm has become aware of the potential for disruption (flickering) in the video laryngoscopy image when Gl
| Recall number | Z-1035-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Verathon, Inc., Bothell, WA, United States |
| Recall initiated | 2016-01-29 |
| Classified | 2016-03-10 |
| Reported by FDA | 2016-03-16 |
| Terminated | 2017-03-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, CA, DE, DK, ES, FR, GB, HK, IT, LU, NL, SA, SE, SG |
| Reason classes | device malfunction |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1035-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.