SUREPULSE MEDICAL LTD is recalling several sizes of the Surepulse VS Cap, which is a component of the VS Newborn Heart Rate Monitor. The recall was initiated because the product labeling contains an incorrect sizing guide for the caps, which are used on newborns. The affected models include Extra Small, Small, Medium, Large, and Extra Large sizes distributed worldwide.
An incorrect sizing guide may lead healthcare providers to select a cap that does not fit the newborn properly. An ill-fitting cap could result in inaccurate heart rate monitoring or delays in medical assessment during critical newborn care.
Component of VS Newborn Heart Rate Monitor; Recall #: Z-1356-2026
Component of VS Newborn Heart Rate Monitor; Recall #: Z-1357-2026
Component of VS Newborn Heart Rate Monitor; Recall #: Z-1358-2026
Component of VS Newborn Heart Rate Monitor; Recall #: Z-1359-2026
Component of VS Newborn Heart Rate Monitor; Recall #: Z-1360-2026
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Sources: FDA iRES · Raw API Response
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