FDA recall Z-1358-2026

Product

Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor

Reason for recall

Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.

Distribution

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.

Key facts

Status

Ongoing

Initiation date

2023-01-20

Report date

2026-02-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Nottingham, N/A, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1358-2026