Cap Recall: Surepulse VS Large SP-162-A1
Announced 2026-02-18 · FDA
FDA recall of SUREPULSE MEDICAL LTD for the Surepulse VS Cap Large SP-162-A1 component of the VS Newborn Heart Rate Monitor due to retroactively reported labeling that provides an incorrect sizing guide for the Cap. The recall involves DI Number: 05060550650044 and Lot numbers 13816/00001 through 13840/00001, with worldwide distribution including US states CT and TX and the United Kingdom, the Netherlands, and the United Arab Emirates. The recall severity is low.
| Brand | SUREPULSE MEDICAL LTD |
|---|---|
| Product | Surepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart Rate Monitor |
| Reason | Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor. |
| Severity | low |
| Units affected | N/A |
| 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. |
| Agency | FDA |
| Recall / campaign no. | DI Number: 05060550650044/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 |
WHAT YOU SHOULD DO
- Check if you own the affected Cap Large SP-162-A1 by reviewing the listing for the DI number and the relevant lot numbers (13816/00001 to 13840/00001).
- Contact your healthcare provider or medical device supplier for guidance on next steps or replacement.
- Monitor FDA updates and Surepulse Medical Ltd notices for further instructions.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.