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Surepulse Medical Ltd FDA Recalls
5 recalls on file across devices, 0 of them Class I and 5 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate MonitorClass IIIJan 20, 2023Retroactively reported; Labeling contains incorrect sizing |
| Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate MonitorClass IIIJan 20, 2023Retroactively reported; Labeling contains incorrect sizing |
| Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate MonitorClass IIIJan 20, 2023Retroactively reported; Labeling contains incorrect sizing |
| Surepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart Rate MonitorClass IIIJan 20, 2023Retroactively reported; Labeling contains incorrect sizing |
| Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate MonitorClass IIIJan 20, 2023Retroactively reported; Labeling contains incorrect sizing |