Updated 27/06/2026
“`htmlThe U.S. Food and Drug Administration (FDA) has announced a Class I recall involving specific sterile syringe labels used with the Omnicell i.v.STATION Automated Compounding System. According to the FDA, inconsistent detection of certain syringe labels may result in unlabeled or mislabeled sterile filled syringes, creating a risk of medication errors that could cause serious adverse health consequences or death.
FDA Announces Class I Recall
The FDA recall notice states that Omnicell is recalling specific sterile syringe labels used with the i.v.STATION Automated Compounding System because inconsistent detection of certain syringe labels may result in unlabeled or mislabeled sterile filled syringes.
According to the FDA, use of an unlabeled or mislabeled syringe could result in medication errors that may cause serious adverse health consequences or death.
FDA Recommendations
The FDA states that Omnicell notified customers to discontinue use of the affected sterile syringe labels, quarantine affected inventory, and use the manufacturer’s recommended alternative labels. Customers are instructed to contact Omnicell Technical Support for replacement products and additional guidance.
According to the FDA, as of April 10, 2024, Omnicell had not reported any serious injuries or deaths associated with this issue.
Inconsistent detection of certain syringe labels may result in unlabeled or mislabeled sterile filled syringes.
— U.S. Food and Drug Administration
Key takeaways
- FDA classified the recall as Class I, the agency’s most serious recall category.
- The recall involves specific sterile syringe labels used with the Omnicell i.v.STATION Automated Compounding System.
- Inconsistent label detection may result in unlabeled or mislabeled sterile filled syringes.
- Healthcare facilities should discontinue use of affected labels and follow Omnicell’s recall instructions.
- According to the FDA, no serious injuries or deaths had been reported as of April 10, 2024.
Frequently asked questions
Which products are affected?
The recall applies to specific sterile syringe labels used with the Omnicell i.v.STATION Automated Compounding System.
Why were these products recalled?
According to the FDA, inconsistent detection of certain syringe labels may result in unlabeled or mislabeled sterile filled syringes.
What should healthcare facilities do?
Healthcare facilities should follow Omnicell’s recall instructions, discontinue use of affected sterile syringe labels, quarantine affected inventory, use the manufacturer’s recommended alternative labels, and contact Omnicell Technical Support for replacement products and additional guidance.
How serious is this recall?
The FDA has classified this action as a Class I recall, meaning there is a reasonable probability that use of the affected product will cause serious adverse health consequences or death.
Healthcare facilities using the affected products should follow the manufacturer’s recall instructions and implement the recommended corrective actions described in the FDA recall notice.
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Disclaimer. This article is health journalism intended for general information and education. It is not medical advice and is not a substitute for professional diagnosis or treatment. Always consult a qualified healthcare provider about your individual circumstances. Full disclaimer →
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Medically reviewed by Prof. Giorgi Pkhakadze, MD, MPH, PhD. Spotted an error? Contact the editorial team.
