Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart… — Class III medical device recall Z-1358-2026
Ongoing recall by SUREPULSE MEDICAL LTD, reported 2026-02-18, distributed nationwide. Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monito
| Recall number | Z-1358-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SUREPULSE MEDICAL LTD, Nottingham, N/A, United Kingdom |
| Recall initiated | 2023-01-20 |
| Classified | 2026-02-12 |
| Reported by FDA | 2026-02-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, GB, IE, NL |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 05060550650020 |
| Lot numbers | 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 |
| Model numbers | SP-161-A1 |
Product
Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor
Reason for recall
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1358-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.