FDA-Device2026-02-18Class IIIMISBRANDING
Surepulse VS Cap Extra Small for newborn heart rate monitor recalled for incorrect sizing labeling
What this means
Surepulse Medical has recalled the VS Cap Extra Small (REF: SP-159-A1), a component of the VS Newborn Heart Rate Monitor, because the labeling includes an incorrect sizing guide. This labeling error could lead to improper cap selection for the device.
- Review the sizing guide on your Surepulse VS Cap Extra Small labeling
- Contact Surepulse Medical or your healthcare provider for correct sizing information
- Do not use the device until you confirm the correct cap size
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 Small REF: SP-159-A1 component of VS Newborn Heart Rate Monitor
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1356-2026Want us to check the next one for you?
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