FDA DevicesClass III
Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Moni...
Published: February 18, 2026Recall ID: Z-1358-2026Category: devicesCountry: US
Reason for Recall / Hazard
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
Product Description & Identification
Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor
Affected Products
Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor
Additional Source Details
| Field | Value |
|---|---|
| City | Nottingham |
| State | N/A |
| Event id | 98292 |
| Address 1 | Medicity D6 Thane Road |
| Address 2 | N/A |
| Code info | DI Number: 05060550650020/Lot: 13816/00001 13817/00001 13818/00001 13819/00001 13820/00001 13821/00001 13822/00001 13823/00001 13824/00001 13825/00001 13826/00001 13827/00001 13828/00001 13829/00001 13830/00001 13831/00001 13832/00001 13833/00001 13834/00001 13835/00001 13836/00001 13837/00001 13838/00001 13839/00001 13840/00001 |
| Postal code | N/A |
| Report date | 20260218 |
| Product type | Devices |
| Product quantity | N/A |
| Reason for recall | Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20230120 |
| Initial firm notification | N/A |
| Center classification date | 20260212 |
Overview
- Recalling FirmSUREPULSE MEDICAL LTD
- StatusOngoing
- Risk LevelClass III
- DistributionWorldwide - US Nationwide distribution in the states of CT, TX and the countries of United Kingdom of Great Britain and Northern Ireland, Netherlands, United Arab Emirates.