FDA-Device2026-02-18Class IIIMISBRANDING
Surepulse VS Cap Medium for newborn heart rate monitor recalled for incorrect sizing labeling
LABEL MIX UPNationwide distribution
Check Surepulse VS Cap Medium sizing label
Surepulse Medical has recalled the VS Cap Medium (part number SP-161-A1), a component of the VS Newborn Heart Rate Monitor, because the labeling contains an incorrect sizing guide. This labeling error could affect proper fit of the cap during use.
- Locate your VS Cap Medium component and check the lot number against the list provided by Surepulse Medical
- Review the correct sizing information with Surepulse Medical or your healthcare provider before using the monitor
- Contact your supplier or Surepulse Medical for corrected labeling or product guidance
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 Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1358-2026Don't want to check this manually?
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