Surepulse VS Cap Small recall: Labeling Error
Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate Monitor
Why was Surepulse VS Cap Small recalled?
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate Monitor
- Recalling firm
- SUREPULSE MEDICAL LTD
- Quantity
- N/A
- Distribution
- Worldwide - US Nationwide distribution in the states of CT, TX and the countries of United Kingdom of Great Britain and Northern Ireland, Netherlands, United Arab Emirates.
- Recall date
- February 18, 2026
- Classification
- Class III
- Status
- Ongoing
- Agency
- FDA (device)