FDA-Device2026-02-18Class IIIMISBRANDING
Surepulse VS Cap Medium for newborn heart rate monitor recalled for incorrect sizing labeling
What this means
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
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 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-1358-2026Want us to check the next one for you?
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