RobotRisk / Omnicell / 2026-03-25

medical robotics · recall

FDA Class I recall: Rolls of label stock used with the Omnicell i.v.Station.

S4 · 03/25
2026 · Omnicell

Record

Company	Omnicell
Category	medical robotics
Type	recall
Date	03/25 2026
Time of day	not documented
Location	no physical site (recall / fleet-wide / aggregate record)
Severity	S4 (serious injury, total loss, or grounding)
Scale	Rolls of label stock used with the Omnicell i.v.Station.
Confidence	high
Verification	Yes - adversarially checked against the cited source
Source	openFDA enforcement

What happened

FDA enforcement record (Class I, recall Z-2047-2026): Potential for mislabeled syringe produced by the i.v.STATION device.

Omnicell record context

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medical robotics context

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Comparable recall events in medical robotics

Sev	Date	Company	Event
S2	2026-06-09	CMR Surgical	Class II recall of Versius surgeon console over disabled Secure Boot cybersecurity control
S5	2026-03-11	Intuitive Surgical	Class I recall of da Vinci SureForm stapler reloads after patient death
S3	2026-01-21	Auris Health (J&J MedTech)	FDA Class II recall: MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-0
S3	2025-09-12	Noah Medical	FDA Class II recall: Brand Name: Galaxy System
S3	2025-05-23	Quantum Surgical	FDA Class II recall: EPIONE Model 30-0001
S3	2025-04-23	Virtual Incision	FDA Class II recall: MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical sur
S3	2025-02-26	Intuitive Surgical	Class II recall of da Vinci 5 foot pedal over spring failure
S3	2024-10-28	Noah Medical	FDA Class II recall: Galaxy System (GAL-001).

Other Omnicell entries

None on file.

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