Severity
Critical
CriticalClass IOngoing
FDA Devices recall · Reported May 20, 2026
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.
Potential for mislabeled syringe produced by the i.v.STATION device.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Omnicell, Inc. recalled Rolls of label stock used with the Omnicell i.v.Station. 1. Part Number 258920028, L… - a critical-severity action.
Rolls of label stock used with the Omnicell i.v.Station. 1. Part Number 258920028, L… was recalled by Omnicell, Inc. in May 20, 2026. Reason: Potential for mislabeled syringe produced by the i.v.STATION device.. Check the official notice for the remedy. Verify recall #Z-2047-2026 with the FDA Devices before acting.
The recall
Omnicell, Inc. issued this critical-severity FDA Devices recall-Potential for mislabeled syringe produced by the i.v.STATION device..
- Critical
- severity level
- 220 units
- affected scope
- Class I
- classification
- May 20, 2026
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2047-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2047-2026) was formally reported on May 20, 2026, with the manufacturer initiating the action on March 25, 2026. It is classified under Critical severity (Class I), with a current status of Ongoing. Omnicell, Inc. is listed as the recalling firm, operating out of Cranberry Township, PA. Federal records list the affected scope as 220 units.
The documented reason for this recall is: Potential for mislabeled syringe produced by the i.v.STATION device. Distribution data in the federal record shows the product reached: US Distribution in Alabama, Maryland and Pennsylvania.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
220 units
Related Recalls
6
3 from same agency
Product description
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.
Reason for recall
Potential for mislabeled syringe produced by the i.v.STATION device.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-2047-2026 |
| Date reported | May 20, 2026 |
| Date initiated | March 25, 2026 |
| Recalling firm | Omnicell, Inc. |
| Firm location | Cranberry Township, PA |
| Affected scope | 220 units |
| Distribution | US Distribution in Alabama, Maryland and Pennsylvania. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2047-2026) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Omnicell, Inc.. Units affected: 220 units.
Why was this product recalled? ▼
Potential for mislabeled syringe produced by the i.v.STATION device.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 20, 2026. Severity: Critical. Recall number: Z-2047-2026.
Where was the recalled product distributed? ▼
Distribution: US Distribution in Alabama, Maryland and Pennsylvania..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2047-2026) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported May 20, 2026. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.