Recall Z-1357-2026 ยท DQA Oximeter
SUREPULSE MEDICAL LTD
Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate Monitor
| Date | Feb 12, 2026 (initiated Jan 20, 2023) |
| Status | Open, Classified |
| Reason | Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor. |
| Root cause | Labeling Change Control |
| Action | 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. |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K201887 | VS Newborn Heart Rate Monitor Surepulse Medical Limited, Jul 23, 2021 |