⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

SUREPULSE MEDICAL LTD: Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate Monitor

Medical DevicesSource: FDA (device) · Date: 2026-02-18

Read the official notice at FDA (device) →

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Guides: Which agency handles which recall (FDA vs USDA vs CPSC vs NHTSA)

The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
SUREPULSE MEDICAL LTD
Product
Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate Monitor
Reason / hazard
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
Classification
Class III
Status
Ongoing
Distribution / sold at
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.
Recall initiated
2023-01-20
Code info
DI Number: 05060550650006/Lot: 13816/00001 13817/00001 13818/00001 13819/00001 13820/00001 13821/00001 13822/00001 13823/00001 13824/00001 13825/00001 13826/00001 13827/00001 13828/00001 13829/00001 13830/00001 13831/00001 13832/00001 13833/00001 13834/00001 13835/00001 13836/00001 13837/00001 13838/00001 13839/00001 13840/00001
Product quantity
N/A
Voluntary mandated
Voluntary: Firm initiated
City
Nottingham
State
N/A
Country
United Kingdom
Event id
98292
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