BEUDAMED
    FDA Recall Open, Classified

    Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor

    Recall: Z-1358-2026 · Initiated January 20, 2023

    Recall

    Recall Number
    Z-1358-2026
    Event Number
    98292
    Firm
    SUREPULSE MEDICAL LTD Medicity D6 Thane Road Nottingham United Kingdom
    FEI Number
    3018685978
    Product Code
    DQA
    Status
    Open, Classified
    Root Cause
    Labeling Change Control
    Initiated
    January 20, 2023
    Posted
    February 12, 2026

    Description

    Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor

    Reason

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

    Action

    On January 13, 2023, Surepulse issued a recall notification to affected consignees. Surepulse asked consignees to take the following actions: 1. Attach the notice to the box where the VS Caps are stored or return the VS Caps to SurePulse for adjustment to the label. 2. Acknowledge receipt of the notification.

    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.