HIGH

Surepulse Medical Issues Recall for Newborn Heart Rate Monitor Component

Surepulse Medical recalled the VS Cap Small component of its newborn heart rate monitor on January 20, 2023. The recall stems from incorrect sizing information provided on the product label. This defect poses a significant risk to patient safety.

Quick Facts at a Glance

Recall Date
January 20, 2023
Hazard Level
HIGH
Brand
SUREPULSE MEDICAL
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
INFANTS, GENERAL

Hazard Information

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

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact SUREPULSE MEDICAL LTD or your healthcare provider for instructions. Notification method: N/A

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Product Details

The recalled product is the Surepulse VS Cap Small, reference number SP-160-A1. It has been distributed worldwide, including nationwide in the United States, specifically in Connecticut and Texas. The distribution also extends to the United Kingdom, Netherlands, and the United Arab Emirates.

The Hazard

The recall involves a labeling error that contains an incorrect sizing guide for the cap. This mislabeling can lead to improper use of the heart rate monitor, potentially compromising patient safety.

What to Do

Patients and healthcare providers should cease using the device immediately. Contact Surepulse Medical Ltd or your healthcare provider for further instructions.

Contact Information

For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1357-2026.

Key Facts

  • Recall date: January 20, 2023
  • Labeling error in product sizing
  • Distributed worldwide including the US and UK
  • High hazard level due to potential patient risk
  • Immediate action required to stop use

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
INFANTSGENERAL
Injury Types
OTHER

Product Details

Model Numbers
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
Affected States
ALL
Report Date
February 18, 2026
Recall Status
ACTIVE

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