FDA-Device2026-02-18Class IIIMISBRANDING
Surepulse VS Cap Extra Large for newborn heart rate monitor recalled for incorrect sizing labeling
What this means
Surepulse Medical has recalled the VS Cap Extra Large component used in their VS Newborn Heart Rate Monitor because the labeling includes an incorrect sizing guide. This could lead to improper fit of the cap on the monitor. No injuries have been reported.
- Check if you have a Surepulse VS Newborn Heart Rate Monitor with an Extra Large cap (REF: SP-163-A1)
- Review the labeling on your device against the correct sizing information from Surepulse Medical
- Contact Surepulse Medical for corrected labeling or instructions if your cap does not fit properly
The agency's original wording
Hazard
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
Intended for
Infants (under 12 months)
Illnesses reported
None reported
Sold states
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.
Affected count
N/A
Manufactured in
Medicity D6 Thane Road, N/A, Nottingham, N/A, United Kingdom
Products
Surepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart Rate Monitor
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1360-2026Want us to check the next one for you?
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