SUREPULSE MEDICAL LTD
SUREPULSE MEDICAL LTD appears in FDA public data with 5 recalls, 0 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-1359-2026, Class III) was initiated on January 20, 2023.
Summary
- Total Recalls
- 5
- 510(k) Clearances
- 0
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1359-2026 | Class III | Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Monitor | January 20, 2023 |
| Z-1360-2026 | Class III | Surepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart Rate Monitor | January 20, 2023 |
| Z-1357-2026 | Class III | Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate Monitor | January 20, 2023 |
| Z-1356-2026 | Class III | Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate Monitor | January 20, 2023 |
| Z-1358-2026 | Class III | Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor | January 20, 2023 |