Surepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart Rate Monitor
Pending LLM rewrite. Source: FDA_DEVICE Z-1360-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
The recalled product
- Product
- Surepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart Rate Monitor
- Manufacturer
- SUREPULSE MEDICAL LTD
- Category
- Medical Device — Devices
Distribution
Distributed nationwide across the United States.
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