Z-1357-2026 Class III Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- February 18, 2026
- Initiation Date
- January 20, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate Monitor
Reason for Recall
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
Distribution Pattern
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.
Code Information
DI Number: 05060550650013/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