Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate Monitor
- Recall Initiated
- January 20, 2023
- Posted
- February 12, 2026
- Recall Number
- Z-1356-2026
Reason for Recall
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
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.
Lot / Code Info
DI Number: 05060550650006/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
Root 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.