The Recall Desk

Hazard

Alarm Malfunction recalls

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

What the numbers show

Total
14
Critical
0
Severe
3
Most recent
2025-01-22

Of the 14 alarm malfunction recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (21%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all alarm malfunction 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.

1–14 of 14

  • SevereFDA (Devices)·Z-0886-2025·2025-01-22

    Welch Allyn Life2000 Ventilator Battery Charger Malfunction Recall

    Baxter Healthcare Corporation is recalling Welch Allyn Life2000 Ventilation Systems due to a battery charger malfunction that triggers an alarm and renders the ventilator inoperable.

    Product
    Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002AP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3153-2024·2024-10-02

    Ivenix Infusion Pump Software Recalled for Potential Malfunctions

    Fresenius Kabi is recalling Ivenix Infusion System software (Version 5.9.1 and prior) due to anomalies that can cause pump malfunctions, alarms, or unresponsive screens while delivering medication, risking serious patient harm.

    Product
    Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion management system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1183-2024·2024-03-06

    Infusion Pumps Model Z-800WF Recalled Due to Alarm Volume Malfunction

    Zyno Medical recalls Z800 infusion pumps (Model Z-800WF) with software version 5.2.05 due to a potential alarm volume malfunction. The alarm may revert to low volume, delaying therapy and risking organ failure in extreme cases.

    Product
    Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids, blood and blood products to a patient under the direction or supervision of physician or other certified health care professional Model: Z-800WF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0864-2024·2024-02-07

    Smiths Medical Medfusion 4000 Syringe Pump Software Defects Recall

    The FDA is recalling Smiths Medical Medfusion Model 4000 syringe pumps due to software defects affecting medication delivery, alarms, and display accuracy. Users should install the latest software version to correct these issues.

    Product
    smiths medical Medfusion Model 4000 syringe pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1381-2022·2022-07-20

    Ivenix Infusion System Devices Recalled for Alarm Sequencing Defect

    The Ivenix Infusion System may malfunction where an occlusion alarm is immediately followed by a pump problem alarm, potentially delaying proper identification of the issue. FDA is recalling 1,335 affected devices.

    Product
    Ivenix Infusion System (IIS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1692-2021·2021-06-09

    Draeger Babylog VN600 Critical Care Ventilators Recalled for Software Defects

    Draeger Medical is recalling Babylog VN600 ventilators due to three software issues: unexpected unit restarts, incorrect oxygen-level alarms, and failure of the automated weaning protocol. These defects could affect patient care and safety.

    Product
    Critical Care Ventilator, Catalog Number(s): 8422200: Babylog VN600 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1693-2021·2021-06-09

    Babylog VN800 Critical Care Ventilator Recalled for Software Malfunctions

    Draeger Medical is recalling critical care ventilators due to software defects causing unexpected unit restarts, incorrect oxygen level alarms, and suspension of weaning therapy. Twelve units were distributed nationwide.

    Product
    Critical Care Ventilator, Catalog Number(s): 8422400: Babylog VN800 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0051-2019·2018-10-10

    Oridion Capnostream20 Monitors Recalled for Settings Reset Issue

    Oridion Medical is recalling five refurbished Capnostream20 monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    Capnostream20 (INTL) N REFURBISHED, CS78652
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0024-2019·2018-10-10

    Oridion CAPNOSTREAM 20 Patient Monitors Recalled for Settings Reset

    Oridion Medical is recalling CAPNOSTREAM 20 patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    CAPNOSTREAM 20 (US) N W/PRINTER, Part Number CS08657
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1816-2017·2017-04-19

    Hill-Rom TotalCare Bed Systems Recalled for Alarm Malfunction

    Hill-Rom is recalling TotalCare Bed Systems because the exit alarm may fail if armed for over 72 hours without triggering.

    Product
    TotalCare Bed Systems, Model Numbers P1900, PR1900, and U1900 with 3-Level Patient Position Monitoring and Scale Upgrade Kits, Model Numbers P1947A and P1948A).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0670-2017·2016-12-07

    Baxter Recalls Sigma Spectrum Infusion Pumps Due to Speaker Failure Risk

    Baxter Healthcare is recalling 5,976 Sigma Spectrum Infusion Pumps because some speakers may fail prematurely, potentially affecting audible alarms.

    Product
    sigma spectrum VOLUMETRIC INFUSION PUMP with Master Drug Library, V6 Spectrum Infusion Pump, Product Code 35700BAX and 35700BAXR, Unique Device Identifier GTIN 00085412091570, Rx ONLY -- Sigma, LLC Medina, NY 14103 --- NOTE: The speakers are a part of the rear case assembly loca
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0672-2017·2016-12-07

    Baxter Recalls SIGMA Spectrum Infusion Pump Rear Case Assemblies

    Baxter Healthcare is recalling 439 V6 Rear Case Assemblies for SIGMA Spectrum Infusion Pumps because the speakers may fail prematurely.

    Product
    V6 Rear Case Assembly, Product Code 35701, a replacement part for the SIGMA Spectrum Infusion Pump -- SIGMA LLC Medina, NY 14103 --- NOTE: The speakers are a part of the rear case assembly located in the back of the infusion pump. The speaker is intended to generate audible ton
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2201-2013·2013-09-25

    GE Healthcare Recalls CARESCAPE Monitor B850 for Alarm Priority Issue

    GE Healthcare is recalling 636 CARESCAPE Monitor B850 units due to a software issue that may cause incorrect alarm priorities when managed via the iCentral network.

    Product
    GE Healthcare, CARESCAPE Monitor B850. Intended for use in multiple areas within a professional healthcare facility.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·08267·2008-05-15

    Maple Chase Recalls FireX Carbon Monoxide Alarms Due to Malfunction

    Maple Chase is recalling FireX carbon monoxide alarms that may malfunction, potentially exposing users to hazardous CO levels.

    Product
    FireX Branded 10000 Series Carbon Monoxide (CO) Alarms and 12000 Series CO/Smoke Combo Alarms
    Category
    Consumer Product
    Distribution
    Distributed nationwide