Omnicell Syringe Labels May Cause Mislabeling on i.v.STATION
Summary
The FDA is alerting healthcare providers about Omnicell syringe labels used with the i.v.STATION automated compounding system that may cause mislabeling. Omnicell issued a letter on April 10 recommending affected customers remove and discontinue use of specific sterile syringe labels. The issue involves inconsistent label detection behavior across i.v.STATION printers that could result in unlabeled or mislabeled syringe preparations. No serious injuries or deaths have been reported as of the notification date. Healthcare providers should immediately segregate affected labels and contact Omnicell Technical Support.
“Inconsistent label detection could result in unlabeled or mislabeled syringe preparations after compounding completion where the above identified sterile labels are utilized.”
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What changed
Omnicell has issued a letter recommending removal of specific IVSTATION SYRINGE sterile labels (part numbers 258920028 and 258920029) due to inconsistent label detection behavior across i.v.STATION printers. The FDA Early Alert warns that this defect could result in unlabeled or mislabeled syringe preparations after compounding completion. Affected healthcare providers using i.v.STATION automated compounding systems must immediately cease use of the affected sterile labels, revert to non-sterile yellow-backed labels, and implement heightened pharmacist verification. As of April 10, no serious injuries or deaths have been reported.
What to do next
- Do not use labels affected by this recall. If you or your staff locate any affected labels, immediately segregate and contact Omnicell Technical Support.
- Revert to the use of previously ordered non-sterile syringe labels with yellow backing (part number HR060027 and HR060071).
- Engage in vigilant pharmacist verification practices to verify the accuracy of labels per your existing review process.
Archived snapshot
Apr 24, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
CDRH is issuing this Early Alert **to notify the public of a potentially high-risk device issue.* The FDA will keep the public informed and update this web page as significant new information becomes available.*
Affected Product
The FDA is aware that Omnicell has issued a letter to affected customers recommending certain syringe labels used with the i.v.STATION automated compounding system be removed from where they are used or sold.
Affected devices:
- IVSTATION SYRINGE sterile label (40MMX40MM) - part number 258920028
- IVSTATION SYRINGE sterile label (20MMX40MM) - part number 258920029 These labels come individually wrapped in a plastic overwrap with a white backing.
What to Do
Do not use affected labels. Verify accuracy of labels on filled products.
On April 10, Omnicell sent all affected customers a letter recommending the following actions:
- Do not use labels affected by this recall. If you or your staff locate any affected labels, immediately segregate and contact Omnicell Technical Support.
- Revert to the use of previously ordered non-sterile syringe labels with yellow backing (part number HR060027 and HR060071).
- Engage in vigilant pharmacist verification practices to verify the accuracy of labels per your existing review process.
- Share this information with all those who need to be aware within your organization. Check this web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.
Reason for Alert
Omnicell received a report of mislabeling that could affect sterile syringe labels produced using i.v.STATION. Omnicell identified inconsistent label detection behavior across i.v.STATION printers when using the sterile labels affected by this recall.
Inconsistent label detection could result in unlabeled or mislabeled syringe preparations after compounding completion where the above identified sterile labels are utilized.
As of April 10, Omnicell has reported no serious injuries or deaths associated with this issue.
Device Use
i.v.STATION is an automation device that limits the need to manually handle vials, solutions, IV bags, and syringes during the preparation and compounding of IV medications, while also minimizing cross-contamination between drugs. As part of the device's automation, it applies labels to compounded preparations for identification and traceability.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact Omnicell at 817-3574904.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
- ## Content current as of:
04/24/2026
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