CLASS II ONGOING Device recall · Reported 31 Dec 2025 · FDA Enforcement Report
BD Pyxis MedStation ES recalled by CareFusion 303
CareFusion 303 is recalling BD Pyxis MedStation ES, distributed nationwide in the US. The recall was initiated on 20 Nov 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-0962-2026
- FDA event ID
- 97712
- Recalling firm
- CareFusion 303, San Diego, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 20 Nov 2025
- FDA classified
- 19 Dec 2025
- Reported
- 31 Dec 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 20 Nov 2025 | Recall initiated by company | |
| 19 Dec 2025 | Classified by FDA | +29 days |
| 31 Dec 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
Automated Dispensing Cabinets (ADC) received a Half Height CUBIE drawer firmware update, which caused a Cubie Insert event which prompts software to generate a duplicate address, which causes an error and the drawer to fail, which may lead to inability or delay in accessing stored items, delay in the replenishment of ADCs or patient specific medications stored outside of ADCs.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
BD Pyxis MedStation ES, REF: 323, BD Pyxis MedStation ES 7 Drawer Auxiliary, REF: 324, BD Pyxis MedStation ES Tower, REF: 352, BD Pyxis Pro 7-Drawer Auxiliary, REF: 1149-00, BD Pyxis Pro 7- Drawer Auxiliary with Secure Tower, REF: 1152-00, BD Pyxis Pro MedStation Main, REF: 1155-00, BD Pyxis CII Safe ES, REF: 1116-00
Where it was distributed
Worldwide - US Nationwide distribution including in the states of CO, IN, OH, TX, KS, FL, GA, NC, CA, HI, IL, NY, MI, VA, AL, LA, NE, KY, OK, AR, TN, WY, NJ, WI, SD, AZ, NV, MO, MA, ID, WV, DE, PA, WA, MT, CT, IA, MD, PR, MN, NM, OR, VT, MS, ME, AK, UT, DC, GU, SC, NH, RI, ND, AS and the countries of CH, CA, KW, QA, NL, GB, UY, AU, NZ, BH, TH, SG, CN, FR, LB, BS, HK, TR, PL, AR, BR, CL, CO, MX, ES, BM, SA, IL.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusetts
Questions about this recall
Why was it recalled?
Automated Dispensing Cabinets (ADC) received a Half Height CUBIE drawer firmware update, which caused a Cubie Insert event which prompts software to generate a duplicate address, which causes an error and the drawer to fail, which may lead to inability or delay in accessing stored items, delay in the replenishment of ADCs or patient specific medications stored outside of ADCs.
Which lots are affected?
Firmware Version: 1.48. REF/UDI-DI: 323/10885403512667, 324/10885403512681, 352/10885403512674, 1149-00/10885403517822, 1152-00/10885403517839, 1155-00/10885403521300, 1116-00/10885403512605
Where was it sold?
Worldwide - US Nationwide distribution including in the states of CO, IN, OH, TX, KS, FL, GA, NC, CA, HI, IL, NY, MI, VA, AL, LA, NE, KY, OK, AR, TN, WY, NJ, WI, SD, AZ, NV, MO, MA, ID, WV, DE, PA, WA, MT, CT, IA, MD, PR, MN, NM, OR, VT, MS, ME, AK, UT, DC, GU, SC, NH, RI, ND, AS and the countries of CH, CA, KW, QA, NL, GB, UY, AU, NZ, BH, TH, SG, CN, FR, LB, BS, HK, TR, PL, AR, BR, CL, CO, MX, ES, BM, SA, IL.
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.
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 |
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