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Open, Classified

Surepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart Rate Monitor

FDA Recall Z-1360-2026 · Posted 2026-02-12

Recalling FirmSUREPULSE MEDICAL LTD
Recall StatusOpen, Classified
Product CodeDQA
Date Initiated2023-01-20

Reason for Recall

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

Firm Action

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.

Root Cause

Labeling Change Control

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K201887VS Newborn Heart Rate MonitorSurepulse Medical Limited · 2021-07-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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