Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Monitor recall — FDA Z-1359-2026
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
Overview of recall records associated with SUREPULSE MEDICAL LTD, including dates, categories and classifications where available.
Classification mix: Class III: 5.
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
This page summarizes recall records in which the official source identifies SUREPULSE MEDICAL LTD as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.