Class I Recall: Omnicell Removes Syringe Labels Used with i.v.STATION Automated Compounding System

What this means for your practice

For healthcare operators who compound or dispense IV medications — including hospital-affiliated outpatient infusion centers, compounding-adjacent medspas administering IV drips, and any facility using automated compounding equipment — this Class I recall demands immediate attention. Mislabeled or unlabeled syringes represent one of the highest-risk medication errors possible: the wrong drug, wrong dose, or wrong concentration can be administered to a patient without any visible warning. If your facility uses the Omnicell i.v.STATION system, you must audit your inventory now, quarantine affected labels (part numbers 258920028 and 258920029), and confirm with your pharmacist team that all filled products have been verified for labeling accuracy. Telehealth brands that partner with compounding pharmacies or infusion suites should proactively confirm those partners have received the Omnicell customer letter dated April 10 and have taken corrective action. Failure to act on a Class I recall can expose facilities to FDA enforcement, state board discipline, and significant liability.

FDA Class I Recall: Omnicell i.v.STATION Syringe Labels

Published: May 21, 2026 | Source: FDA Medical Device Recalls and Early Alerts

What Happened

The FDA has classified a product removal by Omnicell as a Class I Recall — the agency's most serious recall designation, reserved for situations where continued use of a device may cause serious injury or death.

The recall involves two specific sterile syringe labels used with Omnicell's i.v.STATION Automated Compounding System:

• IVSTATION SYRINGE sterile label (40MM x 40MM) — Part Number 258920028
• IVSTATION SYRINGE sterile label (20MM x 40MM) — Part Number 258920029

Both affected labels come individually wrapped in a plastic overwrap with a white backing. The FDA first issued an Early Alert on April 24, 2026, and upgraded the classification to Class I Recall on May 21, 2026.

Why These Labels Were Recalled

Omnicell received a report of mislabeling associated with sterile syringe labels produced using the i.v.STATION system. Upon investigation, the company identified inconsistent label detection behavior across i.v.STATION printers when the affected sterile labels are in use.

This inconsistency can result in:

• Unlabeled syringe preparations after compounding is complete
• Mislabeled syringe preparations after compounding is complete

In a medication compounding environment, an unlabeled or mislabeled syringe is a critical patient safety failure. The i.v.STATION device is specifically designed to automate the preparation and compounding of IV medications — including applying labels for identification and traceability — while minimizing manual handling of vials, solutions, IV bags, and syringes, and reducing cross-contamination between drugs. When the labeling function fails, the traceability and safety integrity of the entire compounded preparation is compromised.

As of April 10, 2026, Omnicell had reported no serious injuries or deaths associated with this issue.

What Affected Facilities Must Do

On April 10, 2026, Omnicell sent a letter to all affected customers directing the following actions:

1. Do not use the recalled labels (part numbers 258920028 and 258920029). 2. Verify the accuracy of labels on any already-filled products before use. 3. If affected labels are located, immediately segregate them and contact Omnicell Technical Support. 4. Revert to previously ordered non-sterile syringe labels with yellow backing — part numbers HR060027 and HR060071. 5. Engage in vigilant pharmacist verification practices to confirm label accuracy per your existing review process. 6. Share this information with all relevant personnel within your organization.

The FDA directs anyone with adverse reactions, quality problems, or questions to contact Omnicell directly at 817-357-4904.

What Is a Class I Recall?

The FDA's Class I designation is its highest-severity recall classification. According to the FDA, a Class I recall applies when there is a reasonable probability that use of or exposure to a violative product will cause serious adverse health consequences or death. This classification signals that the agency views the mislabeling risk as a genuine threat to patient safety — not a theoretical or low-probability concern.

The FDA maintains a full enforcement report and recall database entry for this action through its CDRH Medical Device Recall Database.

Implications for Healthcare Operators

Facilities using Omnicell i.v.STATION equipment — including hospital outpatient departments, compounding pharmacies, and IV therapy clinics — should treat this as an urgent compliance and patient safety matter.

Key action items for healthcare operators:

• Audit your supply chain immediately. Confirm whether your facility has received or is currently using labels with part numbers 258920028 or 258920029.
• Do not use recalled labels under any circumstances. The FDA has classified continued use as potentially life-threatening.
• Review already-compounded products. Any syringe preparations labeled using the affected labels should be subject to pharmacist verification before administration.
• Document your response. Maintaining a written record of your facility's recall response — including inventory checks, quarantine actions, and staff communications — is essential for demonstrating regulatory compliance in any future inspection or audit.
• Notify downstream partners. Telehealth platforms and healthcare brands that work with infusion providers or compounding pharmacies should confirm that their partners have received and acted upon the Omnicell customer letter.

For medspas and IV therapy businesses: If your facility offers IV drip therapy or other compounded IV preparations and uses automated compounding equipment, confirm with your compounding pharmacy whether this recall affects any products you have received or are currently administering.

How to Report Adverse Events

Healthcare professionals and consumers who have experienced adverse reactions or quality problems related to this device should report them through the FDA's MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

Timeline of FDA Communications

| Date | Action | |---|---| | April 10, 2026 | Omnicell sends customer letter recommending label removal | | April 24, 2026 | FDA issues Early Alert to notify the public of a potentially high-risk device issue | | May 21, 2026 | FDA upgrades classification to Class I Recall |

Source: FDA — Automated Compounding System Recall: Omnicell Removes Syringe Labels Used with the i.v.STATION Automated Compounding System · Thu, 21 May 2026 00:00:00 EDT