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Low risk Baby & KidsClass III

Surepulse VS Cap Large Recall

Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Monitor

Updated January 20, 2023

Surepulse VS Cap Large (model SP-162-A1), a component of the VS Newborn Heart Rate Monitor, has been recalled because the labeling includes an incorrect sizing guide for the cap. The inaccurate sizing information could lead to improper fit.

Is the SUREPULSE MEDICAL LTD recalled? Yes. This product was recalled by FDA on January 20, 2023. Details below.

What is recalled

Surepulse VS Cap Large, model reference SP-162-A1, a component of the VS Newborn Heart Rate Monitor manufactured by Surepulse Medical Ltd.

Am I affected

You're affected if you have a VS Newborn Heart Rate Monitor that includes the Surepulse VS Cap Large component with the reference number SP-162-A1.

What to do right now

Contact Surepulse Medical Ltd for corrected sizing guidance or a replacement component with accurate labeling.

The hazard

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

Brands affected

SUREPULSE MEDICAL LTD
Source
FDA
Category
Baby & Kids
Recall ID
fda-Z-1359-2026
Classification
Class III
Recalled
January 20, 2023
Read the official notice

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