Recall archive / FDA device enforcement
Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor — FDA record Z-1358-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jan 20, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- Recalling firm
- SUREPULSE MEDICAL LTD
- Quantity
- N/A
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1358-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
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 below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Feb 18, 2026
- Recall initiation date
- Jan 20, 2023
- Center classification date
- Feb 12, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.