Omnicell recalls

Omnicell has 3 recalls on record with the FDA and USDA, the earliest in 2023 and the latest reported on 20 May 2026. 3 are still ongoing. 1 was reported in the last 12 months. The most frequent reason is labeling errors.

Total recalls3since 2023

Last 12 months1reported

Class I133% of total

Ongoing3latest 20 May 2026

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 1Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 1 0 0Jul 0 0

Severity split

Class I 1 33%Class II 2 67%Class III 0 0%

Why omnicell is recalled

Product types

Syringes & Needles267%
Other Medical Devices133%

By year

2026133%
2025133%
2023133%

Ongoing omnicell recalls

3 active

Reported	Class	Recall	Company	Reason	Where
20 May 2026Device	CLASS I	Rolls of label stock used with the Omnicell i.v.Station recalled	Omnicell	Labeling Errors	AL, MD, PA
16 Apr 2025Device	CLASS II	IVX Station Reconstitution Transfer Set recalled by Omnicell	Omnicell	Sterility	AL
31 May 2023Device	CLASS II	IVX Station-For use in the automated preparation recalled by OmniCell	OmniCell	Device Malfunction	AL, NY

All omnicell recalls, newest first

3 total

Reported	Class	Recall	Company	Reason	Where
20 May 2026Device	CLASS I	Rolls of label stock used with the Omnicell i.v.Station recalled	Omnicell	Labeling Errors	AL, MD, PA
16 Apr 2025Device	CLASS II	IVX Station Reconstitution Transfer Set recalled by Omnicell	Omnicell	Sterility	AL
31 May 2023Device	CLASS II	IVX Station-For use in the automated preparation recalled by OmniCell	OmniCell	Device Malfunction	AL, NY

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.