CLASS II ONGOING Device recall · Reported 5 Nov 2025 · FDA Enforcement Report
All Serial Numbers/BD Pyxis CII Safe ES Tower Main, REF recalled
CareFusion 303 is recalling All Serial Numbers/BD Pyxis CII Safe ES Tower Main, REF: 1116-00, distributed nationwide in the US. The recall was initiated on 30 Sep 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-0371-2026
- FDA event ID
- 97566
- Recalling firm
- CareFusion 303, San Diego, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Sep 2025
- FDA classified
- 27 Oct 2025
- Reported
- 5 Nov 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 30 Sep 2025 | Recall initiated by company | |
| 27 Oct 2025 | Classified by FDA | +27 days |
| 5 Nov 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
Product as listed by the FDA
All Serial Numbers/BD Pyxis CII Safe ES Tower Main, REF: 1116-00
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Canada, United Arab Emirates, Australia.
Questions about this recall
Why was it recalled?
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
Which lots are affected?
Ref #/UDI: 1116-00 10885403512605
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Canada, United Arab Emirates, Australia.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 97566This product is part of a recall event; the main page for the event is BD Pyxis Pro MedStation Main recalled by CareFusion 303.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | BD Pyxis Pro MedStation Main recalled by CareFusion 303 | CareFusion 303 | Other | Nationwide | |
| CLASS II | Various models of BD Pyxis MedFlex, Reference numbers recalled | CareFusion 303 | Other | Nationwide | |
| CLASS II | Various models of BD Pyxis Pro 7-Drawer Auxiliary, Reference numbers recalled | CareFusion 303 | Other | Nationwide | |
| CLASS II | Various models of BD Pyxis Medbank: Reference numbers recalled | CareFusion 303 | Other | Nationwide |
More recalls from CareFusion 303
All 143| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | BD Pyxis MedStation ES Tower recalled by CareFusion 303 | CareFusion 303 | Temperature Abuse | Nationwide |
| Device | CLASS II | BD Pyxis MedBank Mini recalled by CareFusion 303 | CareFusion 303 | Temperature Abuse | Nationwide |
| Device | CLASS II | BD Pyxis MedStation recalled by CareFusion 303 | CareFusion 303 | Temperature Abuse | Nationwide |
| Device | CLASS II | BD Pyxis Anesthesia Station ES recalled by CareFusion 303 | CareFusion 303 | Temperature Abuse | Nationwide |
| Device | CLASS II | BD Pyxis MedStation ES recalled by CareFusion 303 | CareFusion 303 | Temperature Abuse | Nationwide |
Other Other Medical Devices recalls
All 13,908| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Plastics Tray kits recalled by Avid Medical | Avid Medical | Foreign Material | Nationwide |
| Device | CLASS II | Heart Prep Tray kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Pack Open Heart Cfh kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Sperm Ab Elisa (96 well plate test) recalled by DRG International | DRG International | Other | Nationwide |
| Device | CLASS III | BeneView Series recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |