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: 05060550650006/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 Extra Small is a component of the VS Newborn Heart Rate Monitor. It is used in medical settings to monitor heart rates in newborns, which is critical for patient care.
Why This Is Dangerous
The hazard arises from an incorrect sizing guide, which could lead to improper application of the heart rate monitor cap. This mislabeling can result in inaccurate heart rate readings, potentially jeopardizing patient safety.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers should stop using the device immediately to avoid any risks associated with inaccurate heart rate monitoring.
Practical Guidance
How to identify if yours is affected
- Check if your heart rate monitor component is the Surepulse VS Cap Extra Small.
- Verify the model number and lot numbers against the recall notice.
- If unsure, consult your healthcare provider.
Where to find product info
The model number and lot numbers can typically be found on the packaging or on the device itself.
What timeline to expect
The timeline for refunds or replacements has not been specified in the recall notice.
If the manufacturer is unresponsive
- Contact the company again with your original correspondence as documentation.
- Consider reaching out to consumer protection agencies if you receive no response.
How to prevent similar issues
- When purchasing medical devices, always check for current recalls.
- Ensure that sizing information and product instructions are clear and accurate.
Documentation advice
Keep records of your purchase, correspondence with the manufacturer, and any documentation related to the recall.
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Product Details
The recalled product is the Surepulse VS Cap Extra Small, REF: SP-159-A1. It was distributed worldwide, including Connecticut and Texas in the US, the United Kingdom, the Netherlands, and the United Arab Emirates.
Key Facts
- Recall date: January 20, 2023
- Classification: Class III
- Labeling contains incorrect sizing guide
- Distributed in US, UK, Netherlands, UAE
- No reported injuries or incidents
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