FDA Device recall Z-1356-2026
Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate Monitor
- FDA Device
- Class III
- ongoing
- Published 2026-02-18
On 2026-02-18 the FDA classified a Class III recall of Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate Monitor by Surepulse Medical, citing retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1356-2026 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2023-01-20 |
| Published | 2026-02-18 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Surepulse Medical |
| Distribution | US |
Product
Surepulse VS Cap Extra Small REF: SP-159-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.
Identifiers
| code_info | DI Number: 05060550650006/Lot: 13816/00001 13817/00001 13818/00001 13819/00001 13820/00001 13821/00001 13822/00001 138…DI Number: 05060550650006/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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1356-2026%22
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