FDA Medical devices recall ·
Surepulse VS Cap Medium recall
- Recall number
- Z-1358-2026
- Date
- (initiated January 20, 2023)
- Company / brand
- Surepulse Medical Ltd
Medicity D6 Thane Road, Nottingham, N/A, United Kingdom - Category
- Medical devices › Class III
- Classification
- Class III
- Status
- Ongoing
- Units affected
- N/A
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor
Why was it recalled?
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
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.
States: Connecticut Texas
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (medical devices), recall Z-1358-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.