FDA-Device2026-02-18Class IIIMISBRANDING
Surepulse VS Cap Extra Small for newborn heart rate monitor recalled for incorrect sizing labeling
LABEL MIX UPNationwide distribution
Check Surepulse newborn heart monitor cap labeling
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
Hazard
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
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-1356-2026Don't want to check this manually?
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