Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate Monitor
FDA device recall Z-1356-2026 · posted 2026-02-12 · Open, Classified
Recall details
- Recalling firm
- SUREPULSE MEDICAL LTD
- Reason for recall
- Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
- Action taken
- On January 13, 2023, Surepulse issued a recall notification to affected consignees. Surepulse asked consignees to take the following actions: 1. Attach the notice to the box where the VS Caps are stored or return the VS Caps to SurePulse for adjustment to the label. 2. Acknowledge receipt of the notification.
- Root cause
- Labeling Change Control
- Status
- Open, Classified
- Product code
- DQA
- 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.
- Date initiated
- 2023-01-20
- Date posted
- 2026-02-12
- Location
- Nottingham, United Kingdom
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VS Newborn Heart Rate Monitor (K201887) | Surepulse Medical Limited | 2021-07-23 |