Omnicell i.v.Station Label Stock Recall

Source: FDA · Alabama, Maryland, Pennsylvania

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

Omnicell, Inc. is recalling 220 units of label stock used with the i.v.Station device due to the potential for mislabeled syringes.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on June 2, 2026 and geographically references Alabama, Maryland, Pennsylvania. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.

Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.

What Happened

Omnicell, Inc. initiated a voluntary recall of rolls of label stock used with the Omnicell i.v.Station due to the potential for mislabeled syringes produced by the device.

Which Products Are Affected

The recall involves 220 units of the following products distributed in Alabama, Maryland, and Pennsylvania:

  • Part Number 258920028, LABEL, STERILE, IVSTATION SYRINGE (40MMX40MM), Lot Number: QN 200023473
  • Part Number 258900029, LABEL, STERILE, IVSTATION SYRINGE (20MMX40MM), Lot Number: QN 200023474

Model/Catalog Number: IVS-RBT-001. The i.v.STATION is an automation device used for preparation and compounding of IV medications.

Recall Number: Z-2047-2026. Classification: Class I. Recall initiation date: March 25, 2026.

What You Should Do

Consumers and healthcare facilities should contact Omnicell, Inc. regarding the recalled products.

Why This Matters

This Class I recall involves label stock for an IV medication compounding device, where mislabeling could affect identification and traceability of preparations.

Source

FDA recall Z-2047-2026 (event ID 98717)

Original source: FDA Official Notice ↗

All FDA Recalls →

Nationwide notices with similar length or severity timing 8

Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Omnicell, Inc. is recalling 220 units of label stock used with the i.v.Station device due to the potential for mislabeled syringes.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "high" severity. Take precautions and monitor for updates.
What area is affected?
This alert affects Alabama, Maryland, Pennsylvania. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.