SUREPULSE MEDICAL LTD 2026-02-18 Health moderate FDA
Health · FDA · Recall #FDA-Z-1359-2026
Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Monitor Recall
Issued February 18, 2026 · SUREPULSE MEDICAL LTD
In February 2026, SUREPULSE MEDICAL LTD recalled the Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Monitor, a moderate health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
What you should do
- 1 Stop using Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Monitor right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact SUREPULSE MEDICAL LTD to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- SUREPULSE MEDICAL LTD
- Category
- Health
- Recall date
- February 18, 2026
- Units affected
- Not reported
- Sold at
- Worldwide - US Nationwide distribution in the states of CT, TX and the countries of United Kingdom of Great Britain and Northern Ireland, Ne
- Recall number
- FDA-Z-1359-2026
- Made in
- United Kingdom
- Issuing agency
- FDA
In context
- SUREPULSE MEDICAL LTD has 2 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 356th Health recall we've logged in 2026.