Recall Z-1358-2026— SUREPULSE MEDICAL LTD

Name: FDA recall Z-1358-2026
Creator: U.S. Food and Drug Administration
Published: 2023-01-20

Class III · Ongoing

Class III FDA medical device recall by SUREPULSE MEDICAL LTD, initiated 2023-01-20. It names one FDA 510(k) clearance: K201887. Product: Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor. Reason: Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor..

Recalling firm: SUREPULSE MEDICAL LTD
Classification: Class III
Status: Ongoing
Initiated: 2023-01-20
Firm location: Nottingham, N/A, United Kingdom

510(k) clearances named in this recall

1 on FDA's record

K201887 — VS Newborn Heart Rate MonitorSurepulse Medical Limited·cleared 2021-07-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.