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PyxisRecalls & reported problems across all models

Carefusion 303, Inc. · 5 models in the FDA device registry

Data updated Oct 16, 2026 from official FDA records · Editorial policy

16 open recalls name at least one Pyxis model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.

Adverse event reports
7,862
Deaths reported
1
Injuries reported
13
Recalls
16

We found 5 models of Pyxis by Carefusion 303, Inc. in the FDA's device registry (GUDID). Together they are named in 7,862 adverse event reports in the FDA's MAUDE database, received between Nov 5, 2018 and Sep 30, 2026 — classified as 1 death, 13 injuries, 7,843 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (1,031 reports).

16 FDA recall records name at least one of these models by its device identifier, 16 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Reports received per month, all models

Nov 2023: 7 reportsDec 2023: 31 reportsJan 2024: 31 reportsFeb 2024: 41 reportsMar 2024: 39 reportsApr 2024: 20 reportsMay 2024: 43 reportsJun 2024: 27 reportsJul 2024: 16 reportsAug 2024: 23 reportsSep 2024: 23 reportsOct 2024: 49 reportsNov 2024: 20 reportsDec 2024: 49 reportsJan 2025: 172 reportsFeb 2025: 163 reportsMar 2025: 293 reportsApr 2025: 312 reportsMay 2025: 521 reportsJun 2025: 293 reportsJul 2025: 382 reportsAug 2025: 270 reportsSep 2025: 307 reportsOct 2025: 315 reportsNov 2025: 486 reportsDec 2025: 388 reportsJan 2026: 187 reportsFeb 2026: 290 reportsMar 2026: 369 reportsApr 2026: 387 reportsMay 2026: 369 reportsJun 2026: 457 reportsJul 2026: 463 reportsAug 2026: 353 reportsSep 2026: 445 reportsOct 2026: 0 reports202420252026521
Last 36 months. The most recent month may be incomplete.

Pyxis recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

  1. Apr 30, 2026Open, Classified

    Fingerprint scanner may overheat to a temperature to cause 1st degree burn.

    Z-2300-2026 · Root cause: Component design/selection · Recall details · FDA record ↗

  2. Apr 30, 2026Open, Classified

    Fingerprint scanner may overheat to a temperature to cause 1st degree burn.

    Z-2299-2026 · Root cause: Component design/selection · Recall details · FDA record ↗

  3. Apr 30, 2026Open, Classified

    Fingerprint scanner may overheat to a temperature to cause 1st degree burn.

    Z-2297-2026 · Root cause: Component design/selection · Recall details · FDA record ↗

  4. May 8, 2025Open, Classified

    During automated dispensing cabinet upgrade/installation/reimaging, component manager was left in installed mode, and if a Microsoft patch is then installed this may lead to an error preventing user access to the dispensing software application, which may lead to delay in access to medications/supplies, and delivery/replenishment of patient specific orders; which may lead to delay in patient care.

    Z-2017-2025 · Root cause: Software Design Change · names 2 of these models · Recall details · FDA record ↗

  5. May 8, 2025Open, Classified

    Antivirus software was not consistently installed on impacted devices during the implementation process.

    Z-2477-2025 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗

  6. Feb 6, 2025Open, Classified

    Sync timeout may occur between the server and automated dispensing device, due to a server software error which may occur if syncing a large amount of data that takes excessive time, which may cause the dispensing devices to become disconnected from the ES server; dispensing devices will not receive updated information, which may lead to incorrect therapy, and delay in accessing medication.

    Z-1375-2025 · Root cause: Software design · Recall details · FDA record ↗

  7. Jan 8, 2025Open, Classified

    Labeling is insufficient regarding delays in access to medication. The firm is strengthening the label as an additional risk mitigation.

    Z-1120-2025 · Root cause: Labeling design · names 3 of these models · Recall details · FDA record ↗

  8. Jan 8, 2025Open, Classified

    Software issues could potentially result in: 1) delays in accessing dispensing software application, 2) wrong therapy (dose, item, timing, etc.), or 3) unauthorized access and/or compliance related issues

    Z-1119-2025 · Root cause: Software design · Recall details · FDA record ↗

  9. May 2, 2024Open, Classified

    If automated dispensing cabinets have specific software versions, and Component Manager was configured to "installed mode", and software patch KB 5033688 was installed in the production environment, then this will will lead to an error that prevents the user from accessing the dispensing software application, which may delay accessing medication.

    Z-2374-2024 · Root cause: Software change control · Recall details · FDA record ↗

  10. Apr 15, 2024Open, Classified

    Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.

    Z-1932-2024 · Root cause: Component design/selection · Recall details · FDA record ↗

  11. Apr 15, 2024Open, Classified

    Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.

    Z-1928-2024 · Root cause: Component design/selection · Recall details · FDA record ↗

  12. Feb 23, 2024Open, Classified

    Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures of the medication cabinet which could result in delay in accessing medications.

    Z-1125-2025 · Root cause: Device Design · Recall details · FDA record ↗

  13. Feb 1, 2024Open, Classified

    Automated dispensing cabinets, running affected software, and Windows 10 operating system may experience the application randomly hang, freeze and/or crash, which may result in delays in medication access, and potential data loss.

    Z-1223-2024 · Root cause: Software design · Recall details · FDA record ↗

  14. Apr 5, 2023Open, Classified

    Automated dispensing cabinet software is experiencing: 1) ES device download failure resulting in partial patient information loss that leads to 2) partial loss of patient transaction data, seen as a server upload processing error. Outdated/incorrect information display may contribute to the removal of medication to which the patient is allergic, incorrect dose amount, or discontinued medication.

    Z-1579-2023 · Root cause: Software Design Change · Recall details · FDA record ↗

  15. Feb 14, 2023Open, Classified

    Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation 1: Door Latch Failure, Situation 2: Cable Ribbon Damage, Situation 3: Magnet Falling Out,

    Z-0973-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

  16. Feb 14, 2023Open, Classified

    Automated dispensing cabinet drawer firmware may have inadvertently been downgraded to an earlier version of drawer firmware during new device installations or device replacement upgrades, which may lead to an increased frequency of drawer failures, which could increase the likelihood of patients experiencing delays in receiving medications.

    Z-1207-2023 · Root cause: Software change control · Recall details · FDA record ↗

Most reported Pyxis problems

Device problems

  • Computer Software Problem1,031
  • Application Program Problem997
  • Electrical /Electronic Property Problem956
  • Mechanical Problem774
  • Circuit Failure545
  • Installation-Related Problem534
  • Loose or Intermittent Connection495
  • Application Network Problem425

Patient problems

  • No Clinical Signs, Symptoms or Conditions7,831
  • Insufficient Information108
  • Hemorrhage/Blood Loss/Bleeding4
  • No Known Impact Or Consequence To Patient3
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
  • Discomfort2
  • Low Blood Pressure/ Hypotension2
  • Anxiety1

Pyxis models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

Recent Pyxis adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

Other Carefusion 303, Inc. products

All Carefusion 303, Inc. devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page