embecta Medical II LLC
FDA Regulatory Profile
embecta Medical II LLC appears in FDA public data with 2 recalls, 1 510(k) clearance, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-3180-2026, Class II) was initiated on July 26, 2023. Its most recent 510(k) clearance was granted on July 13, 2026.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 1
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-3180-2026 | Class II | EWO_02513 (Catalog number 320122) For Investigational Use Only Nano Un-Cannulated Demo Samples Qu | July 26, 2023 |
| Z-3179-2026 | Class II | EWO_02512 (Catalog number 320550) For Investigational Use Only Nano Pro Un-Cannulated Demo Samples | July 26, 2023 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K260208 | Ultra-Fine SAFETY Insulin Syringe | July 13, 2026 |