The Recall Desk

Hazard

Infusion Interruption recalls

16 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
16
Critical
0
Severe
10
Most recent
2025-01-15

Of the 16 infusion interruption recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 10 (63%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all infusion interruption recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–16 of 16

  • SevereFDA (Devices)·Z-0763-2025·2025-01-15

    Large Volume Pump model LVP-0004 recalled for potential pneumatic valve failure

    Fresenius Kabi is recalling 1,520 Ivenix infusion pumps (model LVP-0004) due to potential pneumatic valve failure that may stop active infusions or prevent pump operation. Affected units were distributed to healthcare facilities in six U.S. states.

    Product
    Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-0355-2024·2023-12-13

    Infusomat Administration Sets recalled for tubing dimension defects

    B. Braun Infusomat Administration Sets may have incorrect tubing dimensions that cause false air-in-line alarms, interrupting medication delivery. The defects may prevent critical medications from reaching patients.

    Product
    Infusomat Administration Sets as listed below: 362031 Infusomat Space Pump Set with Caresite Injection Site; 362032 15 drops/mL, priming volume: 22mL, length: 119in, SafeLine; 362033 UNIV. 15 DR PUMP SET, 1.2 FIL, 2 CRSITE; 362034 Priming volume: 19mL, le
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0124-2024·2023-11-01

    Infusomat Large Volume Pump False Occlusion Alarm May Interrupt Medication

    B. Braun's Infusomat Large Volume Pump battery pack may sound a false occlusion alarm, causing the device to stop pumping. This interruption of high-risk medications can lead to hemodynamic instability and serious medical consequences.

    Product
    8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; Volumetric Infusion Pump System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2204-2021·2021-08-18

    Infusion Pump Module Bezel Repair Parts Recalled for Infusion Hazards

    BioMedical Equipment Service Co (BMES) recalls bezel repair parts for Alaris Infusion Pump Module Model 8100. Non-original parts may crack or separate, causing free flow, over-infusion, under-infusion, or interruption of infusion.

    Product
    Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical Equipment Service Co. (BMES) with an impacted bezel repair part TIPA-8100-4410
    Category
    Medical Device
    Distribution
    9 states
  • SevereFDA (Devices)·Z-2910-2020·2020-09-16

    CareFusion PC Unit Front Case with Keypad Replacement Kits Recalled

    CareFusion 303, Inc. is recalling PC Unit Front Case with Keypad Replacement Kits because fluid ingress may cause keys to become unresponsive or stuck, potentially delaying or interrupting life-sustaining infusions.

    Product
    PC Unit Front Case with Keypad Replacement Kits: TC10008389 ASSY CASE FRONT W/KEYPAD 8015LS, TC10010217 ASSY FRT CASE W/ KEYPAD 8015 M2, TC10012515 ASSY FR CASE W/ KEYPAD 8015 M2, TC10013702 ASSY, CASE, FRONT W/KEYPAD, 8015LS, TC10013664 ASSY FR CASE W/ KEYPAD 8015 M2
    Category
    Medical Device
    Distribution
    52 states
  • SevereFDA (Devices)·Z-2909-2020·2020-09-16

    CareFusion Alaris System PC Unit Model 8015 Recalled for Keypad Defect

    CareFusion is recalling Alaris System PC Unit Model 8015 infusion pumps because fluid ingress can cause unresponsive or stuck keypad keys, potentially delaying or interrupting medication infusions.

    Product
    Alaris System PC Unit Model 8015
    Category
    Medical Device
    Distribution
    52 states
  • SevereFDA (Devices)·Z-2939-2020·2020-09-16

    CareFusion Recalls BD Alaris Infusion Pumps Due to Keypad Defects

    CareFusion is recalling BD Alaris infusion pumps because fluid ingress can cause unresponsive or stuck keys, potentially delaying or interrupting infusions.

    Product
    BD Alaris System PC Unit Model 8100 (Pump Module) and Pump Module Door Assembly Replacement Kits (P/N 49000239, 49000346, 49000438, 49000439) infusion pump.
    Category
    Medical Device
    Distribution
    54 states
  • SevereFDA (Devices)·Z-1362-2020·2020-03-11

    CareFusion Alaris PCA Module Recalled for Software Errors

    CareFusion 303, Inc. is recalling CareFusion Alaris PCA Module, Model 8120 units due to software errors that may cause infusion interruptions or incorrect medication concentrations.

    Product
    CareFusion Alaris PCA Module, Model 8120
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1361-2020·2020-03-11

    CareFusion Alaris Syringe Module Software Error Recall

    CareFusion 303, Inc. is recalling Alaris Syringe Module Model 8110 units due to software errors that may cause infusion interruptions or incorrect medication concentrations.

    Product
    CareFusion Alaris Syringe Module, Model 8110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1360-2020·2020-03-11

    CareFusion Alaris Pump Module Recalled for Software Errors

    CareFusion 303, Inc. is recalling Alaris Pump Module Model 8100 units due to software errors that may cause infusion interruptions or incorrect medication concentrations.

    Product
    CareFusion Alaris Pump Module, Model 8100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1768-2019·2019-07-24

    CareFusion Recalls Alaris Pump Model 8100 Due to Bezel Plastic Weakening

    CareFusion is recalling Alaris Pump Model 8100 units manufactured between April 2011 and June 2017 because the bezel plastic may weaken, potentially causing infusion errors.

    Product
    Alaris Pump, Model 8100, with bezel mechanical assemblies manufactured with FR-110 plastic resin. The following products are affected by this recall as they are pumps or pump assemblies with bezels manufactured between April 2011 and June 2017 with the FR-110 plastic. Alar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1883-2017·2017-05-03

    CareFusion Recalls SmartSite Add-On Bag Access Device Due to Leakage

    CareFusion is recalling 384,923 units of the SmartSite Add-On Bag Access Device because the spike port may separate or leak, potentially interrupting medication infusion.

    Product
    SmartSite Add-On Bag Access Device, Model No. 10013365
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0950-2017·2017-01-25

    CareFusion Recalls Alaris Pump Modules Due to False Air-in-Line Alarms

    CareFusion is recalling Alaris Pump Modules and AIL sensor kits because false Air-in-Line alarms can interrupt medication infusions.

    Product
    Alaris Pump Module, Model No. 8100 and AIL sensor kits, P/N 147083-102 and P/N 49000221. The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids using IV administration sets for continuou
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2873-2016·2016-09-28

    Hospira LifeCare PCA Infusion System Recalled for Screw Rotation Error

    Hospira Inc. is recalling 8,794 LifeCare PCA Infusion Systems because a screw rotation error can cause the pump to alarm and stop infusion.

    Product
    LifeCare PCA Infusion System with Hospira MedNet Software, PCA Serial List Number 20709 Allows for clinician administration or self-administration of analgesic medications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1512-2014·2014-05-07

    Hospira Recalls GemStar Docking Stations Due to Power and Voltage Issues

    Hospira is recalling GemStar Docking Stations because they may cause infusion pumps to fail to power up or stop infusions due to voltage errors.

    Product
    GemStar Docking Station, used with GemStar infusion pump, in combination with other GemStar accessories such as the GemStar Lock Box and patient bolus cord. The docking station is also used for hosting the GemStar pump for general infusions. List Numbers: 13075-XX-XX.
    Category
    Medical Device
    Distribution
    53 states