Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Recalled by SUREPULSE MEDICAL LTD Due to Retroactively reported; Labeling contains incorrect sizing guide for...

Date: January 20, 2023
Company: SUREPULSE MEDICAL LTD
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact SUREPULSE MEDICAL LTD directly.

Affected Products

Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate Monitor

Quantity: N/A

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About SUREPULSE MEDICAL LTD

SUREPULSE MEDICAL LTD has 5 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report