FDA Class I recall: Rolls of label stock used with the Omnicell i.v.Station.
S4 · 25 Mar 2026 · Omnicell
Record
| Company | Omnicell |
| Industry | Medical robotics |
| Type(s) | recall |
| Date | 25 Mar 2026 (day precision) |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | (serious injury, total loss, or grounding) |
| Scale | Rolls of label stock used with the Omnicell i.v.Station. |
| Confidence | high |
| Verified flag | Yes - independently re-checked against the cited source |
Summary
FDA enforcement record (Class I, recall Z-2047-2026): Potential for mislabeled syringe produced by the i.v.STATION device.
Primary source
Publisher: openFDA enforcement · Retrieved: 2026-09-16
Supporting source rows (1)
| Date | Supporting source row | Publisher | Link |
|---|---|---|---|
| 25 Mar 2026 | FDA Class I recall: Rolls of label stock used with the Omnicell i.v.Station. | openFDA enforcement | openFDA enforcement |
Medical robotics context
recall context
Omnicell industry position
Related incidents
Other Omnicell entries
- None on file.
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