FDA-Device2026-02-18Class IIIMISBRANDING
Surepulse VS Cap Large for newborn heart rate monitor recalled for incorrect sizing label
What this means
The labeling for the Surepulse VS Cap Large, a component of the VS Newborn Heart Rate Monitor, contains an incorrect sizing guide. This labeling error could lead to improper fit of the cap during use. No injuries have been reported.
- Review the sizing guide on your Surepulse VS Cap Large labeling
- Contact Surepulse Medical Ltd or your healthcare provider for corrected sizing information
- Do not use the cap if sizing cannot be verified as correct
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 Large REF: SP-162-A1 component of VS Newborn Heart Rate Monitor
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1359-2026Want us to check the next one for you?
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