Z-2047-2026Class I

Rolls of label stock used with the Omnicell i.v.Station. 1. Part Number 258920028, LABEL, STERILE, IVSTATION...

Name: Z-2047-2026 Rolls of label stock used with the Omnicell i.v.Station. 1. Part Number 258920028, LABEL, STERILE, IVSTATION...
Creator: Omnicell, Inc.
Published: 2026-03-25
License: https://open.fda.gov/license/

Omnicell, Inc. / initiated 2026-03-25 / Open, Classified / root cause: manufacturing process

FDA source

Omnicell, Inc. began a recall of Rolls of label stock used with the Omnicell i.v.Station. 1. Part Number 258920028, LABEL, STERILE, IVSTATION SYRINGE (40MMX40MM). 2. Part Number 258900029... on 2026-03-25. FDA classified it as Class I and gives the reason as "Potential for mislabeled syringe produced by the i.v.STATION device". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2047-2026
Classification: Class I
Status: Open, Classified
Initiated: 2026-03-25
Posted: 2026-05-13
Recalling firm: Omnicell, Inc.
Product: 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 is an automation device used for preparation and compounding of IV medications, which also applies labels to compounded preparations for identification and traceability.
Product code: NEP System/Device, Pharmacy Compounding
Reason for recall: Potential for mislabeled syringe produced by the i.v.STATION device.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Omnicell initially notified consignees on about 03/25/2026 via email and internal communication methods to IVCS technicians (Omnicell personnel operating within the hospitals). The communication provided instruction to cease use of new syringe label rolls, any affected units on hand should be segregated and clearly labeled "Do Not Use" until further notice, and to use the old syringe label rolls with the yellow backing. A formal notification was sent on about 04/13/2026. Consignees were instructed that onsite IV Compounding Service Resident Robotic Experts (IVCS RRE(s)) have segregated the impacted stock of the above-identified labels at each facility and have been instructed to return it to Omnicell. If any staff locate any labels with the affected part numbers/names listed in the Alert, please immediately segregate and do not use the label(s), and contact Omnicell Technical Support. Additionally, Omnicell requested that consignees continue to engage in vigilant pharmacist verification practices to verify the accuracy of labels, continue to use previously ordered non-sterile syringe labels, share this information with all those who need to be aware within each organization, and complete and return the Customer Acknowledgment form. Omnicell has taken the following immediate containment actions in relation to this Alert: (1) directed the segregation and discontinuation of use of impacted sterile label stock at each facility; (2) directed resuming use of previously ordered non-sterile syringe labels; and (3) quarantined impacted sterile label stock at Omnicell s manufacturing facility. All immediate containment activities have been completed. Impacted sterile label stock at each facility will be returned to Omnicell by IVCS RRE(s). Any additional corrective or preventative actions will be identified and implemented per Omnicell s standard processes, based on the results of our on-going engineering investigation.
Quantity in commerce: 220 units
Distribution: US Distribution in Alabama, Maryland and Pennsylvania.
Product codes and lots: 1. Part Number 258920028, Lot Number: QN 200023473. 2. Part Number 258900029, Lot Number: QN 200023474.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2047-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2047-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-05-20	2026-05-13

Product code NEP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)