SUREPULSE MEDICAL LTD recalls Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate Monitor

Recall date

January 20, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1356-2026

FDA classification

Class III

Brand / firm

SUREPULSE MEDICAL LTD

Sold / distributed

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.

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate Monitor