Surepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart Rate Monitor
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Low |
| Status | ongoing |
| Recall date | January 20, 2023 |
| Reported | February 18, 2026 |
| Recalling firm | SUREPULSE MEDICAL LTD |
| Country / region | United Kingdom N/A |
Hazard
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
Affected products
- Surepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart Rate Monitor
Related recalls
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