Device recall
Z-1358-2026: Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate…
FDA device recall · Class III · SUREPULSE MEDICAL LTD
Key facts
| Recall number (Z-number) | Z-1358-2026 |
|---|---|
| Recall event | 98292 |
| Product | Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor |
| Product code | DQA |
| Recalling firm | SUREPULSE MEDICAL LTD |
| Recall class | Class III |
| Status | Open, Classified |
| 510(k) numbers | K201887 |
| FEI number | 3018685978 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database