BD Alaris Infusion SystemRecalls & reported problems across all models

We found 29 models of BD Alaris Infusion System by Carefusion 303, Inc. in the FDA's device registry (GUDID). Together they are named in 1,242,913 adverse event reports in the FDA's MAUDE database, received between Oct 23, 2017 and Sep 30, 2026 — classified as 149 deaths, 1,143 injuries, 1,241,620 malfunctions.

The most frequently reported specific device problem is “Crack” (712,302 reports).

16 FDA recall records name at least one of these models by its device identifier, 14 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

BD Alaris Infusion System 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. Feb 11, 2026Open, Classified

   Due to product labeling not indicating which Transport Layer Security (TLS) version that must be enabled on hospital network to ensure secure Wi-Fi communication with Point-of-Care Units

   Z-1645-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Oct 17, 2025Open, Classified

   If infusion pump is dropped or severely jarred this may damage the pump module bezel assembly, which can cause under-infusion, over-infusion, unregulated flow, or pump module failure to calibrate; so dropped/jarred pumps should be removed from use, tested, and inspected by qualified service personnel prior to reuse; tip sheet, cleaning and disinfecting procedure and reference guide updated.

   Z-0430-2026 · Root cause: Device Design · names 4 of these models · Recall details · FDA record ↗

3. Jul 8, 2025Open, Classified

   Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.

   Z-2179-2025 · Root cause: Under Investigation by firm · names 3 of these models · Recall details · FDA record ↗

4. Feb 18, 2025Open, Classified

   Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).

   Z-1304-2025 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗

5. Aug 15, 2024Open, Classified

   Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.

   Z-3142-2024 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗

6. Aug 15, 2024Open, Classified

   Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.

   Z-3141-2024 · Root cause: Process control · names 4 of these models · Recall details · FDA record ↗

7. Aug 15, 2024Open, Classified

   Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.

   Z-3140-2024 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗

8. Aug 15, 2024Open, Classified

   Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.

   Z-3139-2024 · Root cause: Process control · names 6 of these models · Recall details · FDA record ↗

9. Aug 15, 2024Open, Classified

   Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.

   Z-3138-2024 · Root cause: Process control · names 3 of these models · Recall details · FDA record ↗

10. May 21, 2024Open, Classified

    Due to a software issue the PC unit may not connect to the server which could impact wireless data transmission to and from the server.

    Z-2262-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

11. Sep 15, 2023Open, Classified

    Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated.

    Z-0186-2024 · Root cause: Under Investigation by firm · names 3 of these models · Recall details · FDA record ↗

12. Sep 15, 2023Open, Classified

    Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated.

    Z-0185-2024 · Root cause: Under Investigation by firm · names 3 of these models · Recall details · FDA record ↗

13. Sep 15, 2023Open, Classified

    Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated.

    Z-0184-2024 · Root cause: Under Investigation by firm · names 3 of these models · Recall details · FDA record ↗

14. Jan 24, 2023Open, Classified

    Infusion pump PCs with specific software/network cards/IP addresses can have network/wireless connection failure. Could cause inability to receive new datasets and inability to transfer retrospective analytics data to connected systems. Users with interfaces to electronic medication record or admin discharge transfer, may be unable to receive/send data; infusions may need to be manually programmed

    Z-1192-2023 · Root cause: Software Design Change · names 2 of these models · Recall details · FDA record ↗

15. Nov 17, 2017Terminated

    The syringe plunger grippers may fail to automatically close around the syringe plunger press when the gripper control knob has been closed.

    Z-0323-2018 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

16. Nov 17, 2017Terminated

    The syringe plunger grippers may fail to automatically close around the syringe plunger press when the gripper control knob has been closed.

    Z-0322-2018 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported BD Alaris Infusion System problems

BD Alaris Infusion System models

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

• Alaris 8100

  Pump, infusion
  2 recalls2 deaths650,218 reports
• Alaris 8100

  Pump, infusion
  4 recalls78 deaths344,514 reports
• Alaris 8015

  Pump, infusion
  2 recalls45 deaths148,093 reports
• Alaris 8110

  Pump, infusion
  2 recalls4 deaths21,956 reports
• Alaris 8110

  Pump, infusion
  2 recalls2 deaths15,547 reports
• Alaris 8120

  Pump, infusion, pca
  2 recalls4 deaths14,640 reports
• Alaris 8015

  Pump, infusion
  3 recalls6 deaths13,022 reports
• Alaris 8300

  ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
  1 recall2 deaths8,444 reports
• Alaris 8100

  Pump, infusion
  3 recalls1 death6,859 reports
• Alaris™ Pump Module, Model 8100

  Pump, infusion
  1 recall2 deaths5,636 reports
• Alaris 8015

  Pump, infusion
  4 recalls4,302 reports
• Alaris 8110

  Pump, infusion
  2 recalls4,299 reports
• Alaris 2865

  Pump, infusion
  1,404 reports
• Alaris 8120

  Pump, infusion
  2 recalls2 deaths950 reports
• Alaris™ PCA Module, Model 8120

  Pump, infusion, pca
  2 recalls1 death917 reports
• Alaris 8110

  Pump, infusion
  1 recall748 reports
• Alaris 8300

  ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
  1 recall607 reports
• Alaris 8600

  Pump, infusion
  194 reports
• Alaris 8120

  Pump, infusion
  2 recalls70 reports
• Alaris 8975

  Infusion safety management software
  169 reports
• Alaris 8210

  Oximeter
  168 reports
• Alaris 9601

  Infusion safety management software
  2 recalls0 reports
• Alaris 8220

  Oximeter
  77 reports
• Alaris 8120

  Pump, infusion, pca
  1 recall5 reports
• Alaris™ PCA Module, Model 8120

  Pump, infusion
  1 recall1 report
• Alaris 9601

  Pump, infusion
  1 recall0 reports
• Alaris 9601

  Pump, infusion
  32 reports
• Alaris 8975

  Pump, infusion
  27 reports
• Alaris™ Syringe Module, Model 8110 8100

  Pump, infusion
  14 reports

Recent BD Alaris Infusion System adverse event reports

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

• MalfunctionSep 30, 2026Break

  It was reported that the device had missing claws. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945191 ↗
• MalfunctionSep 30, 2026Device Sensing Problem

  It was reported that the following issue was observed on the device: "CRACK IN HINGE & CHANNEL ERROR." Reported Problem Cause Description: "None." Hence, the work Performed in the device includes: "UNIT CHECKED AND FOUND ERROR 240.4150 & CRACK IN HINGE. NEED TO REPLACE PRESSURE SENSOR & DOOR ASSY." There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943561 ↗
• MalfunctionSep 30, 2026Device Sensing Problem

  It was reported that the following issue was observed on the device: ". CRACK IN HINGE & CHANNEL ERROR" Reported Problem Cause Description: "NONE." Hence, the work Performed in the device includes: "UNIT CHECKED AND FOUND ERROR 240.4150 & CRACK IN HINGE. NEED TO REPLACE PRESSURE SENSOR & DOOR ASSY." There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943560 ↗
• MalfunctionSep 30, 2026Device Sensing Problem

  It was reported that the following issue was observed on the device: "CHANNEL ERROR AND BROKEN LVP KEYPAD ASSY." Reported Problem Cause Description: "HARDWARE FAILURE." Hence, the work Performed in the device includes: "Found defective Pressure sensor and LVP keypad assembly and replaced it." There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943554 ↗
• MalfunctionSep 30, 2026Electrical /Electronic Property Problem

  It was reported that the following issue was observed on the device: "BROKEN LVP KEYPAD ASSY." Reported Problem Cause Description: "HARDWARE FAILURE." Hence, the work Performed in the device includes: "Found defective LVP keypad assembly and replaced it." There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943544 ↗
• MalfunctionSep 30, 2026Device Sensing Problem

  It was reported that the following issue was observed on the device: "CHANNEL ERROR.". Reported Problem Cause Description: "FAULTY PRESSURE SENSOR." Hence, the work Performed in the device includes: "UNIT CHECKED AND FOUND ERROR 241.4150. REPLACED PRESSURE SENSOR." There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943543 ↗
• MalfunctionSep 30, 2026Excess Flow or Over-Infusion

  It was reported the PCA continued to infuse following an alarm being triggered. The device continued to infuse at the programmed dose and rate. There was patient involvement; however, outcome is unknown.

  Patient problems: Insufficient Information

  MAUDE report 50943542 ↗
• MalfunctionSep 30, 2026Naturally Worn

  It was reported that the device had broken wiper assembly. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943537 ↗
• MalfunctionSep 30, 2026Contamination

  It was reported that a failure was observed during a planned preventative maintenance, recall remediation, or repair order service event. "[Depot Repair]";"[The door is broken.]". There was no reported patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942242 ↗
• MalfunctionSep 30, 2026Premature Discharge of Battery

  It was reported that a failure was observed during a planned preventive maintenance or recall remediation service event. There was no reported patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942095 ↗
• MalfunctionSep 30, 2026Calibration Problem

  It was reported that a failure was observed during a planned preventative maintenance, recall remediation, or repair order service event. "[Field Service]";"[Door ajar-safety clamp test failed]". There was no reported patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942089 ↗
• MalfunctionSep 29, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935968 ↗
• MalfunctionSep 29, 2026Device Sensing Problem

  It was reported that the following issue was observed on the device: "AIR IN LINE ALARM." Reported Problem Cause Description: "None Provided." Hence, the work Performed in the device includes: "NEED TO REPLACE AIR IN LINE." There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932716 ↗
• MalfunctionSep 29, 2026Display Difficult to Read

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932715 ↗
• MalfunctionSep 29, 2026Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932712 ↗

Other Carefusion 303, Inc. products

• Alaris25 models · 1,236,345 reports · 16 recalls
• BD Pyxis26 models · 81,193 reports · 66 recalls
• Pyxis5 models · 7,862 reports · 16 recalls
• BD Alaris PCU Model 80153 models · 4,071 reports · 2 recalls
• BD Alaris Syringe Module, Model 81102 models · 3,183 reports · 2 recalls
• BD Alaris PCU Module, Model 80152 models · 3,078 reports · 3 recalls
• Alaris PCA Module, Model 81202 models · 918 reports · 2 recalls
• BD Alaris ETCO2 Module, Model 83002 models · 956 reports