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GE Healthcare Ireland Limited FDA Recalls
2 recalls on file across drugs, 0 of them Class I and 2 still open. Matched by name to GEHC.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| GE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., MarlboroughClass IIMar 24, 2026Presence of particulate matter |
| GE Healthcare Omnipaque (iohexol) Injection, 300 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., MarlboroughClass IIMar 24, 2026Presence of particulate matter |