FDA Enforcement
Class III
Ongoing
Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Monitor
Recall: Z-1359-2026
·
Reported February 18, 2026
Enforcement
- Recall Number
- Z-1359-2026
- Event ID
- 98292
- Classification
- Class III
- Status
- Ongoing
- Product Type
- Devices
- Firm
- SUREPULSE MEDICAL LTD
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- N/A
- Report Date
- February 18, 2026
- Initiation Date
- January 20, 2023
- Classification Date
- February 12, 2026
- Address
- Medicity D6 Thane Road, N/A, Nottingham, N/A, N/A, United Kingdom
Description
Surepulse VS Cap Large REF: SP-162-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.
Code Info
DI Number: 05060550650037/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
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.
Quantity
N/A