FDA (Devices) recall action 98292
The FDA (Devices) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
The agency’s own wording, quoted from the enforcement report.
SurePulse Medical is recalling the Surepulse VS Cap Large because the labeling contains an incorrect sizing guide for the cap.
SurePulse Medical is recalling the Surepulse VS Cap Extra Large because the labeling contains an incorrect sizing guide for the cap.
SurePulse Medical is recalling the Surepulse VS Cap Medium because the labeling contains an incorrect sizing guide for the cap.
SurePulse Medical is recalling the Surepulse VS Cap Extra Small because the labeling contains an incorrect sizing guide for the cap.
SurePulse Medical is recalling the Surepulse VS Cap Small because the labeling contains an incorrect sizing guide for the cap.