The Recall Desk

Hazard

Under Infusion recalls

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

What the numbers show

Total
60
Critical
5
Severe
33
Most recent
2025-11-26

Of the 60 under infusion recalls we have scored against our rubric, 5 (8%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 33 (55%) 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 under 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.

51–60 of 60

  • HighFDA (Devices)·Z-2581-2020·2020-07-22

    CME America Recalls BodyGuard Microset Infusion Sets Due to 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 with Male Luer Connectors, REF: A100-163XEBF
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-2582-2020·2020-07-22

    CME America BodyGuard Infusion Sets Recalled for Delivery Inaccuracy

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

    Product
    BodyGuard set with Female Luer, REF: A120-003XSN
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-2554-2020·2020-07-22

    CME America Recalls BodyGuard Microset Infusion Sets Due to Delivery Inaccuracy

    CME America, LLC is recalling BodyGuard Microset infusion administration sets because they may deliver therapy with an inaccuracy exceeding plus/minus 13%, potentially causing over- or under-infusion.

    Product
    BodyGuard Microset, REF: A120-160XPS
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-2556-2020·2020-07-22

    CME America BodyGuard Microset Infusion Sets Recalled for Delivery Inaccuracy

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

    Product
    BodyGuard Microset, REF: A100-163XES
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-1968-2020·2020-05-20

    BD Alaris PCEA Administration Set Recalled for Potential Leakage

    BD Switzerland is recalling 110,350 units of Alaris PCEA Administration Sets due to a potential leak at the luer connection that may cause inadequate pain control.

    Product
    BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 10800177 - Product Usage: Microbore Tubing with Yellow Identification Stripe Anti-siphon Valve Use Aseptic Technique Set cannot be used for gravity infusion. 1. Connect PCA
    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
  • SevereFDA (Devices)·Z-1248-2019·2019-05-08

    Baxter SIGMA Spectrum Infusion Pumps Recalled for Flow Rate Testing Errors

    Baxter Healthcare is recalling 158 SIGMA Spectrum Infusion Pumps because flow rate tests were performed for less than the required time, potentially leading to inaccurate fluid administration.

    Product
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), product code 35700BAX - Product Usage: The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used for the controlled administration of fluids. These fluids may include pharmaceu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1686-2015·2015-06-03

    Medrad Stellant CT Injector System Recalled for Under-Volume Hazard

    Medrad Inc dba Bayer R&I is recalling 133 Stellant CT Injector Systems with Certegra Workstations due to a configuration error that may cause under-infusion of contrast media.

    Product
    MEDRAD¿ Stellant CT Injector System with Certegra Workstation; intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography (CT) applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1874-2013·2013-08-14

    Iradimed MRidium Dose Reduction System Recall for Infusion Rate Errors

    Iradimed is recalling MRidium 1145 Dose Reduction System kits because they may display incorrect infusion rates, posing a risk of over- or under-infusion.

    Product
    MRidium 1145 Dose Reduction System (DERS) drug library kit. (This is an option for the MRidium 3860+MR Infusion Pump System). The MRidium 3860+MRI Infusion pump are intended for general hospital or clinical use by medical professional whenever it is required to infuse patient
    Category
    Medical Device
    Distribution
    Distributed nationwide