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SUREPULSE MEDICAL LTD recalls Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate Monitor
Recalled February 18, 2026 · FDA recall Z-1357-2026 · SUREPULSE MEDICAL
Hazard
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor. · FDA Class III
Units
N/A
Sold at
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.
Description
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
Product
Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate Monitor
Manufacturer(s)
SUREPULSE MEDICAL LTD
Made in
United Kingdom
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →