Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate Monitor
Summary
The FDA issued a Class III for Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate Monit by SUREPULSE MEDICAL LTD. Reason: Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor..
Details
Source
Device Recall
External ID
Z-1357-2026
Action Date
2026-02-18
Status
Ongoing
Category
device
Product Description
Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate Monitor
Lot/Code Info: DI Number: 05060550650013/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
Quantity Affected: N/A
Reason for Recall
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
Distribution
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-01-20
Company
Nottingham, N/A
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 200 device recalls issued in the same week, part of 403 device-related FDA actions this month.
SUREPULSE MEDICAL LTD has 5 FDA actions in our database, including 5 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (SUREPULSE MEDICAL LTD) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SUREPULSE MEDICAL LTD have FDA actions?
SUREPULSE MEDICAL LTD has 5 FDA actions in our database, including 5 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1357-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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