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[Recalled] Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Monitor — Retroactively reported | FDA 2023-01-20

recall fda device united-kingdom

A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.

Recall details

ProductSurepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Monitor
Brand / manufacturerSUREPULSE MEDICAL LTD
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-1359-2026
Country of noticeUnited Kingdom
Risk levelClass III
Hazard typerecall
Notice date20 January 2023
EAN / barcode05060550650037

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.

This Class III recall concerns device products distributed in United Kingdom and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from SUREPULSE MEDICAL LTD

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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