[pending] Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate Monitor
Pending LLM rewrite. Source: FDA_DEVICE Z-1356-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
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 Small REF: SP-159-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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