Class III

Medical Device Recall: Surepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart Rate Monitor

SUREPULSE MEDICAL LTD · January 20, 2023

Reason for Recall

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

Distribution

Worldwide - US Nationwide distribution in the states of CT, TX and the countries of United Kingdom of Great Britain and Northern Ireland, Netherlands, United Arab Emirates.

States Affected

NATIONWIDE

Quantity Affected

N/A

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1360-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.