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
- 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
- Newborn Heart Rate Monitor Component
- Model numbers
- DI Number: 05060550650020/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 Medium is a component of the VS Newborn Heart Rate Monitor, designed for use in neonatal care settings. Healthcare providers purchase this device to monitor vital signs in newborns accurately.
Why This Is Dangerous
The product labeling contains incorrect sizing information, which can lead to improper use and inaccurate heart rate monitoring. This mislabeling could compromise patient safety and care quality.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers must stop using this component, which may disrupt medical services for newborns. The recall indicates a potential risk to patient safety, emphasizing the importance of accurate medical device labeling.
Practical Guidance
How to identify if yours is affected
- Check the product label for REF number SP-161-A1.
- Verify if the cap component matches the recalled model.
- Contact your healthcare provider for assistance.
Where to find product info
The REF number is usually found on the product packaging or the device itself, typically near the barcode or on the label.
What timeline to expect
Expect a response from Surepulse Medical within 4-6 weeks regarding refund or replacement processes.
If the manufacturer is unresponsive
- Document all communications with the company.
- Follow up via email or phone if no response is received within the expected timeline.
- Consider filing a complaint with the relevant health authorities if issues persist.
How to prevent similar issues
- Always verify labeling accuracy before use of medical devices.
- Look for certifications from regulatory bodies when purchasing healthcare equipment.
- Stay informed about recalls and safety alerts in the medical device industry.
Documentation advice
Keep records of the purchase, including receipts, and document any correspondence regarding the recall.
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Product Details
The recalled product is the Surepulse VS Cap Medium, REF: SP-161-A1, which is part of the VS Newborn Heart Rate Monitor. This device was distributed worldwide, including in Connecticut and Texas, as well as the United Kingdom, Netherlands, and United Arab Emirates.
Key Facts
- Recall date: January 20, 2023
- Component affected: VS Cap Medium REF: SP-161-A1
- High hazard classification due to labeling error
- Distributed worldwide including the US and UK
- No reported injuries or incidents
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