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Low severity

Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate Monitor

SourceFDA Device Enforcement
CategoryMedical Device
SeverityLow
Statusongoing
Recall dateJanuary 20, 2023
ReportedFebruary 18, 2026
Recalling firmSUREPULSE MEDICAL LTD
Country / regionUnited Kingdom N/A

Hazard

Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.

Affected products

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