Class IIIReported 2026-02-18

Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor

Recalled by SUREPULSE MEDICAL LTD

Reason for Recall

Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.

Recall Number

Z-1358-2026

Classification

Class III

Status

Ongoing

Category

device

Initiated

2023-01-20

Reported

2026-02-18

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.

Code Info

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

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.