Recall Z-1358-2026
Surepulse Medical Ltd · initiated January 20, 2023
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor
Codes / lots: 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
Reason for recall
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
FDA-determined cause: Labeling Change Control
Action taken
On January 13, 2023, Surepulse issued a recall notification to affected consignees. Surepulse asked consignees to take the following actions: 1. Attach the notice to the box where the VS Caps are stored or return the VS Caps to SurePulse for adjustment to the label. 2. Acknowledge receipt of the notification.
Details
- Recall number
- Z-1358-2026
- Initiated
- January 20, 2023
- Posted by FDA
- February 12, 2026
- Product code
- DQA – Oximeter
- Distribution
- Worldwide - 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.
- Recalling firm
- Surepulse Medical Ltd, Nottingham
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1356-2026 Class III | Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate MonitorRetroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate… | 01/20/2023Open, Classified |
| Z-1357-2026 Class III | Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate MonitorRetroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate… | 01/20/2023Open, Classified |
| Z-1359-2026 Class III | Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate MonitorRetroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate… | 01/20/2023Open, Classified |
| Z-1360-2026 Class III | Surepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart Rate MonitorRetroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate… | 01/20/2023Open, Classified |