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

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

On January 13, 2023, Surepulse issued a recall notification to affected consignees. Surepulse asked consignees to take the following actions: 1. Attach the notice to the box where the VS Caps are stored or return the VS Caps to SurePulse for adjustment to the label. 2. Acknowledge receipt of the notification.

• FDA enforcement recordOfficial FDA database entry for Z-1358-2026
• FDA 510(k) clearance · K201887The device's official FDA premarket clearance record
• FDA device classification · DQAOfficial FDA classification for this device type
• CFR regulation · 21 CFR 870.2700The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find SUREPULSE MEDICAL LTDSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.