CLASS II ONGOING Device recall · Reported 16 Apr 2025 · FDA Enforcement Report
IVX Station Reconstitution Transfer Set recalled by Omnicell
Omnicell is recalling IVX Station Reconstitution Transfer Set, distributed in Alabama. The recall was initiated on 20 Feb 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1532-2025
- FDA event ID
- 96422
- Recalling firm
- Omnicell, Cranberry Township, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 20 Feb 2025
- FDA classified
- 4 Apr 2025
- Reported
- 16 Apr 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 20 Feb 2025 | Recall initiated by company | |
| 4 Apr 2025 | Classified by FDA | +43 days |
| 16 Apr 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
IVX Station Reconstitution Transfer Sets were shipped in advance of the IVX Station upgrade and not intended for clinical use but are engineering devices intended for use during set up and system calibration. The items were not shipped in a validated packing configuration and sterility cannot be ensured.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
IVX 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 Station Pharmacy Compounding System.
Where it was distributed
Distributed in the US to Alabama
Questions about this recall
Is IVX Station Reconstitution Transfer Set recalled?
Yes. Omnicell recalled IVX Station Reconstitution Transfer Set on 20 Feb 2025. The recall is Class II and its status is Ongoing. Recall number Z-1532-2025.
Why was it recalled?
IVX Station Reconstitution Transfer Sets were shipped in advance of the IVX Station upgrade and not intended for clinical use but are engineering devices intended for use during set up and system calibration. The items were not shipped in a validated packing configuration and sterility cannot be ensured.
Which lots are affected?
Model number: 298921215. UDI Number: 0086000726042101124301840119041525, 0086000726042101124300840119041525, 0086000726042101124301680119041525. Lot number 011243.
Where was it sold?
Distributed in the US to Alabama
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Omnicell
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Rolls of label stock used with the Omnicell i.v.Station recalled | Omnicell | Labeling Errors | AL, MD, PA |
| Device | CLASS II | IVX Station-For use in the automated preparation recalled by OmniCell | OmniCell | Device Malfunction | AL, NY |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |