FDA MedWatch Early Alert: Automated Compounding System Issue from Omnicell

Published: 04/24/2026

Sources:
  • Food and Drug Administration
Relevant To:
  • Rural Emergency Hospitals,
  • Critical Access Hospitals,
  • Hospitals,
  • Pharmacy,
  • Rural Health Clinics

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.

As of April 10, Omnicell has reported no serious injuri…

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