Carrigtwohill, Ireland
GE Healthcare Ireland Limited recalls
1 recall recorded since 2018, most recently on 24 March 2026. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Drugs
- Recall started
- 24 March 2026
- Reason
- Presence of particulate matter
- Distribution
- U.S. Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0448-2026, D-0447-2026
- GE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1414-91.
- GE Healthcare Omnipaque (iohexol) Injection, 300 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1413-63.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.