GE Healthcare Ireland Limited

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
0
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0448-2026Class IIGE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%), Rx Only, Distributed by: GE HealthcaMarch 24, 2026
D-0447-2026Class IIGE Healthcare Omnipaque (iohexol) Injection, 300 mg/mL (64.7%), Rx Only, Distributed by: GE HealthcaMarch 24, 2026