FDAFDA · Food and drugs·Recall number Z-1358-2026
Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor
Published February 18, 2026 · Recall initiated: January 20, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- SUREPULSE MEDICAL LTD
- Distributor
- 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.
- Lot
- 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
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United Kingdom
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.