RegWardenFDA facility compliance records
Company

SurePulse Medical Limited

1 recall(s) on record — most severe on record: Class III.

Recalls by year

FDA actions on record by year2023: 1 recalls20172018201920202021202212023202420252026
  • Recalls (1)

Registered facilities (1)

Recalls & enforcement

  • Class IIIOngoing2023-01-20
    Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “SurePulse Medical Limited — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10084383-surepulse-medical-limited/

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