[Recalled] Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor — Retroactively reported | FDA 2023-01-20
Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.
Recall details
| Product | Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor |
|---|---|
| Brand / manufacturer | SUREPULSE MEDICAL LTD |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1358-2026 |
| Country of notice | United Kingdom |
| Risk level | Class III |
| Hazard type | recall |
| Notice date | 20 January 2023 |
| EAN / barcode | 05060550650020 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
This Class III recall concerns device products distributed in United Kingdom and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from SUREPULSE MEDICAL LTD
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.
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