Class I — Verathon, Inc.
| Recalling firm | Verathon Inc. |
|---|---|
| Registered facility | Verathon Inc. (the firm's only registered facility) |
| Classification | Class I |
| Status | Terminated |
| 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. |
| 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 1… |
| Quantity | 7733 units (6377 units in the US and 1356 units International) |
| Distribution | Worldwide Distribution - US (nationwide) and to countries of: Australia, Belgium, Canada, Denmark, France, Germany, Hong Kong, Italy, Luxembourg, Saudi Arabia, Singapore, Spain, Sweden, The Netherlands, U.A.E., and United Kingdom. |
| Initiated | 2016-01-29 |
| Classified | 2016-03-10 |
| Terminated | 2017-03-01 |
| Recall number | Z-1035-2016 |
| 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 I recall — Verathon, Inc. (Z-1035-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/73014/
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