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Incident · Recall

FDA Class I Recall: Omnicell i.v.STATION syringe labels may cause mislabeled sterile preparations

On May 21, 2026, the FDA classified as a Class I recall Omnicell's removal of certain syringe labels used with the i.v.STATION automated compounding system. Inconsistent label detection behavior across i.v.STATION printers could result in unlabeled or mislabeled sterile syringe preparations after compounding. No serious injuries or deaths were reported as of April 2026.

Occurred 2026-04-10 · Omnicell

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Track FDA Class I Recall: Omnicell i.v.STATION syringe labels may cause mislabeled sterile preparations

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Sources (1)

  1. FDA Class I Recall: Omnicell i.v.STATION Syringe Labels · https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/automated-compounding-system-recall-omnicell-removes-syringe-labels-used-ivstation-automated · 2026-05-21

Common questions

What happened in FDA Class I Recall: Omnicell i.v.STATION syringe labels may cause mislabeled sterile preparations?
On May 21, 2026, the FDA classified as a Class I recall Omnicell's removal of certain syringe labels used with the i.v.STATION automated compounding system. Inconsistent label detection behavior across i.v.STATION printers could result in unlabeled or mislabeled sterile syringe preparations after compounding. No serious injuries or deaths were reported as of April 2026.
When did this incident occur?
The incident is recorded as occurring on April 10, 2026 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
Who was involved in FDA Class I Recall: Omnicell i.v.STATION syringe labels may cause mislabeled sterile preparations?
The incident is recorded as involving Omnicell on the DEPLOY registry. No specific robot model is linked to this incident in the registry.
Has anyone responded to FDA Class I Recall: Omnicell i.v.STATION syringe labels may cause mislabeled sterile preparations?
No responses to this incident are recorded on the DEPLOY registry. Operators, manufacturers, or affected parties can submit responses to the editorial team; absence is not a guarantee no response was issued.
What is the current status of FDA Class I Recall: Omnicell i.v.STATION syringe labels may cause mislabeled sterile preparations?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.
Methodology: Verified · 1 source (1 primary) · last reviewed 2026-07-14

Verification posture

Verified

High confidence

Review state

Stable

Last reviewed 2026-07-14

Sources by quality tier

1
primary-fda-database
FDA database

The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.

Methodology surface for FDA Class I Recall: Omnicell i.v.STATION syringe labels may cause mislabeled sterile preparations.

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Canonical ID 268ee279-2055-4d62-b8f9-2bd864d54d76