GE Healthcare Ireland Limited
GE Healthcare Ireland Limited appears in FDA public data with 2 recalls, 0 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-0448-2026, Class II) was initiated on March 24, 2026.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 0
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0448-2026 | Class II | GE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%), Rx Only, Distributed by: GE Healthca | March 24, 2026 |
| D-0447-2026 | Class II | GE Healthcare Omnipaque (iohexol) Injection, 300 mg/mL (64.7%), Rx Only, Distributed by: GE Healthca | March 24, 2026 |