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Omnicell i.v.STATION Syringe Labels
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MEDICAL DEVICE RECALLCRITICAL

Omnicell i.v.STATION Syringe Labels

Omnicell is recalling sterile syringe label stock for the i.v.STATION device due to a risk of mislabeled IV medication syringes.

What to do

Immediately stop using the affected label stock and contact Omnicell for further instructions regarding replacement or remediation.

Recalled
Listed
Updated
Recall No.
Z-2047-2026
Agency
FDA
Firm
Omnicell, Inc.
Recall ID
98717
Status
ONGOING

Recall at a glance

Quantity recalled
220 units

Why it was recalled

Omnicell is recalling specific sterile syringe label stock used with the i.v.STATION automation device due to a potential for mislabeled syringes. This issue can lead to incorrect identification and traceability of compounded IV medications.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

Rolls of label stock used with the Omnicell i.v.Station. 1. Part Number 258920028, LABEL, STERILE, IVSTATION SYRINGE (40MMX40MM). 2. Part Number 258900029, LABEL, STERILE, IVSTATION SYRINGE (20MMX40MM). Model/Catalog Number: IVS-RBT-001. i.v.STATION

Lot code
200023473, 200023474
UDI-DI
258920028, 200023473, 258900029, 200023474

Where it was sold

Distributed in Alabama, Maryland, and Pennsylvania.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated
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Editorial summary by Recall Canary · summary updated 2026-06-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification