Recall Register

Food, drugs, devices › Firms

Omnicell, Inc.

FDA recalling firm · 3 enforcement events · 3 product records · 2023–2026 · PA

Omnicell, Inc. has 3 FDA enforcement events on this register (3 product records) between 2023 and 2026: 3 device; the busiest year was 2023 with 1.

33% of its events are Class I; the most common class is Class II (2). 3 events are listed as ongoing; the recalling firm's address is in PA.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
25 Mar 2026Rolls 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…DeviceClass I1Ongoing
20 Feb 2025IVX Station Reconstitution Transfer Set. Model Number: 298921215. Packaging: 1 set per White Tyvek Pouch, 5 Tyvek Pouches per shelf box, 10 shelf boxes per case box. IVX Station Reconstitution Transfer Set is used for the reconstitution of drug vials in hospital pharmacies. It is indicated for use with the IVX…DeviceClass II1Ongoing
27 Mar 2023Omnicell IVX Station-For use in the automated preparation of pharmaceutical admixtures and syringes Model Number: 298921373DeviceClass II1Ongoing

By type and class

Device3
Class II2
Class I1

Class I: 33% of this firm's events; 18% of all events on the register.

Events by year

23
24
25
26
Enforcement events for Omnicell, Inc. by year initiated.

Questions and answers

How many FDA recalls has Omnicell, Inc. had?

3 enforcement events (3 product records) on this register, 2023–2026: 3 device.

Are any Omnicell, Inc. recalls ongoing?

3 events are listed as ongoing in the current openFDA export.

What class are Omnicell, Inc. recalls?

2 Class II, 1 Class I. 33% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.