Class III — SUREPULSE MEDICAL LTD
| Recalling firm | SurePulse Medical Limited |
|---|---|
| Registered facility | SUREPULSE MEDICAL LIMITED (the firm's only registered facility) |
| Classification | Class III |
| Status | Ongoing |
| Reason | Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor. |
| Product | Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate Monitor |
| Quantity | N/A |
| 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. |
| Initiated | 2023-01-20 |
| Classified | 2026-02-12 |
| Recall number | Z-1357-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — SUREPULSE MEDICAL LTD (Z-1357-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98292/
Alerts for SurePulse Medical Limited
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.