The FDA has posted 5 enforcement recalls from Surepulse Medical Ltd since 2025, none of them Class I (most serious). Most recent report: Feb 18, 2026.
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.
Firm name as filed with the FDA: “SUREPULSE MEDICAL LTD”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.