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: 05060550650044/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 is a component of the VS Newborn Heart Rate Monitor, used primarily in medical settings for monitoring infant heart rates. Parents and healthcare providers utilize this device to ensure the health and well-being of newborns.
Why This Is Dangerous
The recall stems from a labeling error that provides incorrect sizing information for the cap. This may lead to improper fitting, potentially compromising the device's ability to monitor heart rates accurately.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers may face inconvenience in ensuring proper heart rate monitoring for their newborns. Immediate action is required to prevent any potential misuse of the device.
Practical Guidance
How to identify if yours is affected
- Locate the model and lot numbers on the product packaging or device.
- Compare your product with the recall information provided by the FDA.
- If you have the Extra Large VS Cap, it is affected by the recall.
Where to find product info
Check the packaging or the device itself for the model and lot numbers, typically found on a label.
What timeline to expect
Expect a refund or replacement processing timeline of approximately 4-6 weeks.
If the manufacturer is unresponsive
- Contact Surepulse Medical Ltd directly for follow-up.
- Document all correspondence regarding the recall.
How to prevent similar issues
- Always verify product labels before use, especially for medical devices.
- Consult with healthcare professionals regarding device safety.
- Look for FDA recall notices when purchasing medical devices.
Documentation advice
Keep records of your purchase, including receipts and any correspondence with the manufacturer regarding the recall.
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Product Details
The recalled product is the Extra Large VS Cap, REF: SP-163-A1, part of the VS Newborn Heart Rate Monitor. The specific model numbers include DI Number: 05060550650044 along with various lot numbers from 13816 to 13840. The product was distributed worldwide, primarily in Connecticut and Texas.
Key Facts
- Recall date: January 20, 2023
- Product distributed in CT, TX, UK, Netherlands, UAE
- Labeling contains incorrect sizing guide
- No injuries reported
- Class III recall
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Safety Guide
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