SUREPULSE MEDICAL LTD recalls Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor
- Recalling company
- SUREPULSE MEDICAL LTD
- Product
- Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor
- Reason
- Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
- Classification
- Class III – not likely to cause adverse health consequences
- Recall date
- Jan 20, 2023
- Reported
- Feb 18, 2026
- 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.
- Status
- Ongoing
- Quantity
- N/A
- Lot / codes
- 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
- Company location
- Nottingham, N/A
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-1358-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-1358-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.