The Recall Desk

Hazard

Over Infusion recalls

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

What the numbers show

Total
56
Critical
5
Severe
36
Most recent
2026-01-28

Of the 56 over infusion recalls we have scored against our rubric, 5 (9%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 36 (64%) 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 over infusion 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.

1–25 of 56

  • HighFDA (Devices)·Z-1121-2026·2026-01-28

    SIGMA Spectrum infusion pumps recalled over defective grease on the gears

    Baxter Healthcare is recalling 585 SIGMA Spectrum Infusion Pumps because defective grease on the cam and motor gears could lead to over-infusion or a free-flow situation.

    Product
    SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0430-2026·2025-11-26

    Infusion pump modules recalled because drops can damage the bezel assembly

    CareFusion is recalling 2,574,396 BD Alaris Infusion Pump Modules 8100 because a dropped or jarred pump can suffer bezel damage causing under-infusion, over-infusion or unregulated flow.

    Product
    BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF: 49000437; KIT ASSY ONE PIECE BEZEL 8100, REF: 49000270. Used with the following new and updated documents: BD Alaris Infusion System Inspection Safety Reminder, Part: BD-163124, Revision: 00; Clean
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1231-2025·2025-03-05

    Infusion Pump Manual Instructs Users to Leave Safety Clamp Open

    BD Alaris Pump Module user manual incorrectly instructs users to leave the safety clamp open when reloading infusion sets, potentially causing accidental over-infusion.

    Product
    BD Alaris Pump Module REF 8100 The BD Alaris System with Guardrails Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric, and neonatal patients through clinically accepted routes of administra
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-1283-2024·2024-03-20

    Ivenix Infusion System Software Defect May Delay or Cause Incorrect Infusions

    Fresenius Kabi recalls Ivenix Infusion System software versions 5.2.1 and 5.2.2 due to two defects that may delay therapy or cause over-infusion. The software fix was deployed to affected units between May and August 2023.

    Product
    LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1272-2022·2022-06-29

    Medfusion Syringe Pump Class I Recall: Risk of Over-Infusion or Therapy Interruption

    Smiths Medical is recalling multiple Medfusion Syringe Pump models due to software and hardware defects that may interrupt drug infusion or cause over-infusion. Approximately 65,093 units distributed worldwide are affected.

    Product
    Medfusion Syringe Pump Models: 3500, 3500-0600-00, 3500-0600-01, 3500-0600-249, 3500-0600-50, 3500-0600-51, 3500-0600-82, 3500-306, 3500-402, 3500-414, 3500-415, 3500-500, 3500BC, 3500E, 3500G, 3500SD, 3500SD-500, 3500VX, 3500VX-306, 3500VX-414, 3500VX-415, 3500VX-500, 3500ZE, S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1271-2022·2022-06-29

    Medfusion Syringe Pump Recalled Due to Multiple Infusion Control and Alarm Failures

    Smiths Medical recalled 58,671 Medfusion Syringe Pump units worldwide due to multiple failures that could interrupt therapy or cause over-infusion, including defective alarms and display errors.

    Product
    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0819-2022·2022-03-30

    Infusion Pump Risk of Malfunction in B. Braun Perfusor Space Devices

    B. Braun is recalling 6 Perfusor Space infusion pump units that may not function properly due to inadequate inspection, potentially causing incorrect medication dosing and therapy delays.

    Product
    PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that can be used to configure customized, tailor-made solutions Catalog Number: 8713030U
    Category
    Medical Device
    Distribution
    2 states
  • 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
  • CriticalFDA (Devices)·Z-1651-2021·2021-06-09

    Alaris Infusion Pump Module Bezel Repair Parts Recalled for Separation Risk

    FDA recalls 22 serviced Alaris Model 8100 infusion pump units with bezel components that may crack or separate, risking free flow, over-infusion, under-infusion, or treatment interruption. Units distributed to Indiana and Texas between September 2020 and February 2021.

    Product
    Alaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys, with the impacted bezel repair part, TIPA-8100-4410 / Alaris 8100 Bezel.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2736-2020·2020-08-12

    CareFusion Alaris Pump Module Model 8100 Recalled for Broken Platen Elements

    CareFusion 303, Inc. is recalling Alaris Pump Module Model 8100 units because broken platen elements can cause inaccurate fluid delivery, leading to over-infusion, free-flow, or under-infusion.

    Product
    Alaris Pump Module Model 8100
    Category
    Medical Device
    Distribution
    54 states
  • CriticalFDA (Devices)·Z-2553-2020·2020-07-22

    CME BodyGuard BodySet Infusion Sets Recalled for Delivery Inaccuracy

    CME America is recalling BodyGuard BodySet infusion sets because they may deliver therapy at inaccurate rates, potentially causing over-infusion or under-infusion.

    Product
    BodyGuard BodySet, REF: A120-160SAS
    Category
    Medical Device
    Distribution
    49 states
  • CriticalFDA (Devices)·Z-2567-2020·2020-07-22

    CME America Recalls BodyGuard Microset Infusion Sets Due to Delivery Inaccuracy

    CME America, LLC is recalling BodyGuard Microset infusion sets because they may deliver therapy with significant inaccuracy, potentially causing over-infusion or under-infusion.

    Product
    BodyGuard Microset with Needleless Adaptor, REF: A120-003XSNY
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Devices)·Z-2585-2020·2020-07-22

    CME America Recalls Infusion Sets Due to Delivery Inaccuracy

    CME America is recalling Standard BodySet infusion sets because they may deliver therapy at inaccurate rates, potentially causing over- or under-infusion.

    Product
    Standard BodySet with Needleless Connectors, REF: A120-125XS
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Devices)·Z-2588-2020·2020-07-22

    CME BodyGuard Microset Infusion Sets Recalled for Delivery Inaccuracy

    CME America is recalling BodyGuard Microset infusion sets because they may deliver therapy at inaccurate rates, potentially causing over- or under-infusion.

    Product
    BodyGuard Microset With Female Luer, REF: A120-160XPSN
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Devices)·Z-2589-2020·2020-07-22

    CME BodyGuard Microset Infusion Sets Recalled for Delivery Inaccuracy

    CME America is recalling BodyGuard Microset infusion sets due to potential delivery inaccuracies that could cause over- or under-infusion of therapy.

    Product
    BodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer, REF: A120-160CYFRV
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Devices)·Z-2573-2020·2020-07-22

    CME BodyGuard Microset Infusion Sets Recalled for Delivery Inaccuracy

    CME America is recalling BodyGuard Microset infusion sets because they may deliver therapy at inaccurate rates, potentially causing over-infusion or under-infusion.

    Product
    BodyGuard Microset, REF: A100-163XE90S
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Devices)·Z-2563-2020·2020-07-22

    CME America Recalls BodyGuard Microset Infusion Administration Sets

    CME America is recalling BodyGuard Microset infusion administration sets due to delivery inaccuracy that could cause over-infusion or under-infusion of therapy.

    Product
    BodyGuard Microset, REF: A120-161XYBS
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Devices)·Z-2587-2020·2020-07-22

    CME America Recalls CMExpress Needleless Y Site Microbore Sets

    CME America is recalling 1,824 CMExpress Needleless Y Site Microbore Sets due to delivery inaccuracy that could cause over- or under-infusion of therapy.

    Product
    CMExpress Needleless Y Site Microbore Set, REF: A120-160CYNVK
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Devices)·Z-2583-2020·2020-07-22

    CME America Recalls BodyGuard Microset Infusion Sets Due to Delivery Inaccuracy

    CME America is recalling 6,320 BodyGuard Microset infusion sets because they may deliver fluids with significant inaccuracy, potentially causing over- or under-infusion of therapy.

    Product
    BodyGuard Microset with Filter and Manual Priming Valve, REF: A120-112XSFV
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Devices)·Z-2568-2020·2020-07-22

    CME America Recalls CMExpress Microbore Sets Due to Delivery Inaccuracy

    CME America, LLC is recalling CMExpress Microbore Sets because they may deliver fluids with significant inaccuracy, potentially causing over-infusion or under-infusion of therapy.

    Product
    CMExpress Microbore Set, REF: A120-160CRV
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Devices)·Z-2580-2020·2020-07-22

    CME America Recalls CMExpress Microbore Sets Due to Delivery Inaccuracy

    CME America is recalling CMExpress Microbore Sets because they may deliver therapy at inaccurate rates, potentially causing over-infusion or under-infusion.

    Product
    CMExpress Microbore Sets, REF: A120-161C
    Category
    Medical Device
    Distribution
    49 states