FDA-Device2026-02-18Class IIIMISBRANDING
Surepulse VS Cap Small newborn heart rate monitor recalled for incorrect sizing guide labeling
What this means
The labeling for the Surepulse VS Cap Small component of the VS Newborn Heart Rate Monitor contains an incorrect sizing guide. This affects specific lot numbers distributed in the US and several other countries. No injuries have been reported.
- Locate your Surepulse VS Cap Small device and check if the lot number matches the recall list
- Review the sizing guide in the product labeling for accuracy before use
- Contact Surepulse Medical Ltd for clarification on correct cap sizing if you have questions
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 Small REF: SP-160-A1 component of VS Newborn Heart Rate Monitor
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1357-2026Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.