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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- SUREPULSE MEDICAL
- Product type
- Heart Rate Monitor Component
- 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
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
January 20, 2023
Reported by FDA DEVICE
February 18, 2026
RecallRadar source check
February 25, 2026
Consumer action
Use the official remedy and keep documentation.
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
About This Product
The Surepulse VS Cap Small is a component of a newborn heart rate monitor used for monitoring infant health. Healthcare providers and parents buy this product to ensure accurate heart rate readings for newborns during medical assessments.
Why This Is Dangerous
The hazard arises from an incorrect sizing guide on the product label, which could result in improper fitting and usage. This can lead to inaccurate readings, potentially compromising the health and safety of infants.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers may face inconvenience as they need to discontinue use of the device and seek replacements. The potential health risks underscore the urgency of addressing the sizing error.
Practical Guidance
How to identify if yours is affected
- Check the product label for the model number SP-160-A1.
- Verify the DI number if available: 05060550650013.
- Contact your healthcare provider to confirm if your device is affected.
Where to find product info
Look for the model number and DI number on the product packaging or device label.
What timeline to expect
Expect a refund or replacement processing time of approximately 4-6 weeks.
If the manufacturer is unresponsive
- Contact the FDA to report the issue.
- Consider seeking legal advice if you face difficulties with the manufacturer.
How to prevent similar issues
- Always check for updated safety notices on medical devices.
- Verify the accuracy of product labels before use.
- Purchase medical devices from reputable sources.
Documentation advice
Keep copies of your purchase receipt, correspondence with the manufacturer, and any documented medical recommendations.
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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.
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
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