Omnicell, Inc.: 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.

Recall number

Z-2047-2026

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.

Status

Open, Classified

Initiated

2026-03-25

Posted

2026-05-13

Terminated

not on file

Reason

Potential for mislabeled syringe produced by the i.v.STATION device.

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

220 units

Distribution

US Distribution in Alabama, Maryland and Pennsylvania.

Lot, serial or model codes

1. Part Number 258920028, Lot Number: QN 200023473. 2. Part Number 258900029, Lot Number: QN 200023474.

510(k) numbers

not on file

PMA numbers

not on file

Product code

NEP

Firm FEI

3007880912

Firm city

Cranberry Township

Firm state

PA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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