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BD PyxisRecalls & reported problems across all models

Carefusion 303, Inc. · 26 models in the FDA device registry

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

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

Adverse event reports
81,193
Deaths reported
6
Injuries reported
35
Recalls
66

We found 26 models of BD Pyxis by Carefusion 303, Inc. in the FDA's device registry (GUDID). Together they are named in 81,193 adverse event reports in the FDA's MAUDE database, received between Feb 25, 2022 and Sep 30, 2026 — classified as 6 deaths, 35 injuries, 81,121 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (19,944 reports).

66 FDA recall records name at least one of these models by its device identifier, 66 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: 10 reportsDec 2023: 11 reportsJan 2024: 13 reportsFeb 2024: 11 reportsMar 2024: 11 reportsApr 2024: 12 reportsMay 2024: 100 reportsJun 2024: 47 reportsJul 2024: 27 reportsAug 2024: 17 reportsSep 2024: 25 reportsOct 2024: 112 reportsNov 2024: 119 reportsDec 2024: 406 reportsJan 2025: 2,584 reportsFeb 2025: 2,313 reportsMar 2025: 3,280 reportsApr 2025: 2,530 reportsMay 2025: 3,575 reportsJun 2025: 3,996 reportsJul 2025: 5,714 reportsAug 2025: 3,510 reportsSep 2025: 4,031 reportsOct 2025: 4,677 reportsNov 2025: 6,049 reportsDec 2025: 4,488 reportsJan 2026: 2,765 reportsFeb 2026: 3,265 reportsMar 2026: 3,788 reportsApr 2026: 3,478 reportsMay 2026: 3,911 reportsJun 2026: 4,394 reportsJul 2026: 4,399 reportsAug 2026: 3,403 reportsSep 2026: 4,020 reportsOct 2026: 0 reports2024202520266,049
Last 36 months. The most recent month may be incomplete.

BD 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-2304-2026 · 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-2303-2026 · 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-2302-2026 · Root cause: Component design/selection · Recall details · FDA record ↗

  4. Apr 30, 2026Open, Classified

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

    Z-2301-2026 · Root cause: Component design/selection · Recall details · FDA record ↗

  5. Apr 30, 2026Open, Classified

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

    Z-2298-2026 · Root cause: Component design/selection · Recall details · FDA record ↗

  6. Dec 3, 2025Open, Classified

    Due a software issue that may result in equipment not receiving timely updates of patient, medication, or related information from enterprise systems.

    Z-1028-2026 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗

  7. Nov 20, 2025Open, Classified

    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.

    Z-0962-2026 · Root cause: Device Design · names 3 of these models · Recall details · FDA record ↗

  8. Sep 30, 2025Open, Classified

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

    Z-0368-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

  9. Sep 30, 2025Open, Classified

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

    Z-0367-2026 · Root cause: Under Investigation by firm · names 8 of these models · Recall details · FDA record ↗

  10. Jul 10, 2025Open, Classified

    Reports of delayed access to medication in automated dispensing cabinets because of the override/Add Item workflow.

    Z-2321-2025 · Root cause: Use error · names 5 of these models · Recall details · FDA record ↗

  11. 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 4 of these models · Recall details · FDA record ↗

  12. 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 5 of these models · Recall details · FDA record ↗

  13. Mar 11, 2025Open, Classified

    Users trying to restock a single bin location of an automated dispensing cabinet, during pocket exchange restocking workflow, may experience a software issue that results in 2 destock transactions and 2 stock transactions, which results in doubling the bin quantity, which may result in a delay in access to desired medications and/or supplies, which may lead to temporary body function impairment.

    Z-1639-2025 · Root cause: Software design · names 5 of these models · Recall details · FDA record ↗

  14. Mar 11, 2025Open, Classified

    Due to a software bug, automated dispensing cabinet is unable to calculate countback discrepancies during the issue process, which causes incorrect transaction quantity to be recorded. This bug can also result in the CUBIE opening more times than needed for the transaction to be completed, which may result in a patient receiving more than the intended dose of medication.

    Z-1545-2025 · Root cause: Software design · names 5 of these models · Recall details · FDA record ↗

  15. Mar 11, 2025Open, Classified

    Due to a software issue, when attempting to restock the automated dispensing cabinet, user have received the banner message "Stocking window has passed, or item has been removed from purchase order. Please contact Pharmacy for assistance". When this occurs, the medication cannot be restocked and can potentially lead to delays in accessing medication for patients.

    Z-1550-2025 · Root cause: Device Design · names 2 of these models · Recall details · FDA record ↗

  16. 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 · names 2 of these models · Recall details · FDA record ↗

  17. Jan 23, 2025Open, Classified

    Due to fingerprint scanner failing resulting in the scanner heating up.

    Z-1207-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

  18. Jan 10, 2025Open, Classified

    Automated dispensing device labeling is being updated to strengthen labeling around manual access to medications to address the risk of potential delays in retrieving contents/ accessing medications that may result from power loss or potential automated dispensing device malfunctions.

    Z-1206-2025 · Root cause: Labeling design · names 2 of these models · Recall details · FDA record ↗

  19. Jan 8, 2025Open, Classified

    Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms.

    Z-1230-2025 · Root cause: Under Investigation by firm · names 5 of these models · Recall details · FDA record ↗

  20. Jan 8, 2025Open, Classified

    Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms.

    Z-1229-2025 · Root cause: Under Investigation by firm · names 5 of these models · Recall details · FDA record ↗

  21. Jan 8, 2025Open, Classified

    Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms.

    Z-1228-2025 · Root cause: Under Investigation by firm · names 5 of these models · Recall details · FDA record ↗

  22. Jan 8, 2025Open, Classified

    Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms.

    Z-1227-2025 · Root cause: Under Investigation by firm · names 5 of these models · Recall details · FDA record ↗

  23. 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 4 of these models · Recall details · FDA record ↗

  24. 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 · names 2 of these models · Recall details · FDA record ↗

  25. Nov 14, 2024Open, Classified

    Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or position, which can lead to: 1) Unintended and incorrect medication removal, or 2) Potential for a different medication (medication pulled in error) to be refilled/loaded, which may lead to may lead to low inventory or a stockout.

    Z-0671-2025 · Root cause: Software design · Recall details · FDA record ↗

  26. Nov 14, 2024Open, Classified

    Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or position, which can lead to: 1) Unintended and incorrect medication removal, or 2) Potential for a different medication (medication pulled in error) to be refilled/loaded, which may lead to may lead to low inventory or a stockout.

    Z-0670-2025 · Root cause: Software design · Recall details · FDA record ↗

  27. Jun 24, 2024Open, Classified

    Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.

    Z-2503-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

  28. Jun 24, 2024Open, Classified

    Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.

    Z-2502-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

  29. Jun 24, 2024Open, Classified

    Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.

    Z-2501-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

  30. Jun 24, 2024Open, Classified

    Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.

    Z-2500-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

…and 36 older recalls, listed on each model's page.

Most reported BD Pyxis problems

Device problems

  • Mechanical Problem19,944
  • Loose or Intermittent Connection9,100
  • Circuit Failure7,675
  • Computer Software Problem7,574
  • Application Program Problem7,042
  • Electrical /Electronic Property Problem6,425
  • Break5,951
  • Activation Failure4,930

Patient problems

  • No Clinical Signs, Symptoms or Conditions81,114
  • Insufficient Information51
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available32
  • Cardiac Arrest7
  • Convulsion/Seizure4
  • Discomfort4
  • Hemorrhage/Blood Loss/Bleeding4
  • Laceration(s)4

BD Pyxis models

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

Recent BD 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