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
- Heart Rate Monitor Component
- Model numbers
- DI Number: 05060550650037/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 Large is a component of the VS Newborn Heart Rate Monitor, used to measure heart rates in newborns. This product is critical in neonatal care settings for monitoring vital signs.
Why This Is Dangerous
The recall concerns an incorrect sizing guide printed on the product label, which can lead to improper application of the cap, potentially affecting monitoring accuracy and patient safety.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers must stop using the product immediately, potentially disrupting neonatal monitoring processes in healthcare facilities.
Practical Guidance
How to identify if yours is affected
- Check the product label for the model REF: SP-162-A1 and DI Number: 05060550650037.
- Verify the lot numbers against the list provided in the recall announcement.
- If the product matches the recall criteria, stop using it immediately.
Where to find product info
Look for the model and lot numbers on the product packaging or the device itself, usually located on the label or instruction manual.
What timeline to expect
Expect a refund or replacement processing timeline of approximately 4-8 weeks, depending on manufacturer response.
If the manufacturer is unresponsive
- Document all your correspondence with Surepulse Medical.
- Consider contacting the FDA for further assistance if the company is unresponsive.
How to prevent similar issues
- Always check for proper labeling and sizing information before using medical devices.
- Look for recent recalls or safety alerts before purchasing medical equipment.
Documentation advice
Keep all receipts, correspondence regarding the recall, and photos of the product as documentation.
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Product Details
The recalled product is the VS Cap Large (REF: SP-162-A1), a component of the VS Newborn Heart Rate Monitor. Model DI Number: 05060550650037 with various lot numbers was distributed worldwide.
Key Facts
- Recall date: January 20, 2023
- High hazard classification
- Distribution in CT, TX, UK, Netherlands, UAE
- Contact Surepulse Medical for instructions
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