The Recall Desk

Hazard

Device Inoperability recalls

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

What the numbers show

Total
18
Critical
2
Severe
9
Most recent
2025-01-22

Of the 18 device inoperability recalls we have scored against our rubric, 2 (11%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 9 (50%) 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 device inoperability 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.

1–18 of 18

  • CriticalFDA (Devices)·Z-0887-2025·2025-01-22

    Life2000 Ventilation System battery charger defect causes device inoperability

    Baxter Healthcare is recalling the Life2000 Ventilation System due to a battery charger defect that can trigger an alarm, rendering the ventilator inoperable and unable to support patients' breathing.

    Product
    Breathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002AP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0885-2025·2025-01-22

    Welch Allyn Life2000 Ventilator Battery Charger May Cause Device Inoperability

    Baxter Healthcare is recalling 946 Welch Allyn Life2000 ventilators due to a battery charger defect that can trigger an alarm and render the device inoperable.

    Product
    Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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
  • HighFDA (Devices)·Z-2143-2023·2023-07-19

    HeartSine Defibrillator Battery and Electrode Cartridges May Fail to Function

    HeartSine battery and electrode cartridges for defibrillators may contain depleted battery cells, rendering them inoperable and preventing cardiac rhythm analysis or therapy delivery. Approximately 30,022 units are affected worldwide.

    Product
    HeartSine, REF: PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separately and with the HeartSine Samaritan Public Access Defibrillator models: 350P/360P/450P/500P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1775-2022·2022-09-28

    Puritan Bennett 560 Ventilator Recalled for Loss of Gas Supply

    Covidien is recalling the Puritan Bennett 560 Ventilator due to a manufacturing error in turbine components that causes loss of gas supply and device inoperability. Six incidents have been confirmed from customers outside the United States.

    Product
    Puritan Bennett 560 Ventilator, PB560, CFN 4096600
    Category
    Medical Device
    Distribution
    1 state
  • CriticalFDA (Devices)·Z-0344-2022·2021-12-15

    Puritan Bennett 980 Series Ventilators Recalled for Incorrect Capacitor Assembly

    Covidien is recalling 278 Puritan Bennett 980 Series Ventilators worldwide due to incorrect capacitor assembly that may cause devices to become inoperable during patient use.

    Product
    Puritan Bennett 980 Series Ventilator, 980U3ESDIUU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0348-2022·2021-12-15

    Puritan Bennett 980 Ventilator recalled for capacitor assembly defect

    The Puritan Bennett 980 Series Ventilator may become inoperable due to a manufacturing defect in the internal capacitor assembly. A total of 278 units worldwide have been affected.

    Product
    Puritan Bennett 980 Series Ventilator, 980X1ENNISB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0341-2022·2021-12-15

    Puritan Bennett 980 Series Ventilator Recall Due to Manufacturing Defect

    Covidien is recalling 278 Puritan Bennett 980 Series Ventilators due to a manufacturing error where a capacitor was assembled incorrectly, which may cause the device to become inoperable during use.

    Product
    Puritan Bennett 980 Series Ventilator, 980S3ENDICU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0349-2022·2021-12-15

    Puritan Bennett 980 Series Ventilator recalled for assembly defect

    Puritan Bennett 980 Series Ventilators are recalled due to a capacitor assembly error that may cause the device to become inoperable during use. The recall affects 278 units distributed worldwide.

    Product
    Puritan Bennett 980 Series Ventilator, 980X1JADIJJ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0343-2022·2021-12-15

    Puritan Bennett 980 Ventilator Recalled for Capacitor Assembly Error

    Covidien is recalling the Puritan Bennett 980 Series Ventilator due to incorrect capacitor assembly that may cause the device to become inoperable during patient use.

    Product
    Puritan Bennett 980 Series Ventilator, 980U1ESDIUC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0340-2022·2021-12-15

    Puritan Bennett 980 Series Ventilator Recalled for Manufacturing Defect

    Covidien Llc is recalling 278 Puritan Bennett 980 Series Ventilators due to a manufacturing assembly error where a capacitor may have been installed incorrectly, potentially causing device inoperability during use.

    Product
    Puritan Bennett 980 Series Ventilator, 980S1ENDICU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0338-2022·2021-12-15

    Puritan Bennett 980 Series Ventilator recalled for capacitor assembly error

    The Puritan Bennett 980 Series Ventilator is being recalled because a capacitor may be assembled incorrectly, which could cause the ventilator to stop working during use.

    Product
    Puritan Bennett 980 Series Ventilator, 980A1ENNISB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0347-2022·2021-12-15

    Puritan Bennett 980 Series Ventilator Recalled for Manufacturing Assembly Defect

    Covidien LLC is recalling 278 units of the Puritan Bennett 980 Series Ventilator due to a manufacturing defect that may cause the device to become inoperable during clinical use.

    Product
    Puritan Bennett 980 Series Ventilator, 980X1ENDIUU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0345-2022·2021-12-15

    Puritan Bennett 980 Ventilators Recalled Due to Manufacturing Assembly Error

    Covidien is recalling Puritan Bennett 980 Series Ventilators (model 980X1ENAIQC) due to an incorrectly assembled capacitor that may cause the device to become inoperable. The recall involves 278 units distributed worldwide, including the US.

    Product
    Puritan Bennett 980 Series Ventilator,980X1ENAIQC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2471-2021·2021-09-22

    Siemens ACUSON Juniper ultrasound system recalled for intermittent power supply failure

    Siemens Medical Solutions USA is recalling 15 ACUSON Juniper Diagnostic Ultrasound Systems worldwide due to intermittent power supply failures that render the devices inoperable. No injuries or illnesses have been reported.

    Product
    ACUSON Juniper Diagnostic Ultrasound System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2160-2021·2021-08-04

    OEC 3D Imaging X-Ray Systems Recalled for Coin Cell Battery Depletion

    GE OEC Medical Systems is recalling certain OEC 3D Imaging fluoroscopic X-ray systems due to potential premature depletion of the coin cell battery used to monitor X-ray tube temperature, which could cause the system to become inoperable.

    Product
    OEC 3D Imaging, Image-Intensified Fluoroscopic X-Ray System, Mobile - Product Usage: designed to provide fluoroscopic and digital spot images of adult and pediatric populations during diagnostic, interventional, and surgical procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2161-2021·2021-08-04

    OEC Elite Mobile C-Arm Recalled for Battery Depletion

    GE OEC Medical Systems is recalling 3,570 OEC Elite mobile C-arm imaging systems worldwide due to potential early depletion of the battery that monitors X-ray tube temperature, which could render the system inoperable.

    Product
    OEC Elite mobile C-arm - Product Usage: intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1832-2015·2015-07-01

    ArthroCare EVAC 70 XTRA Plasma Wand Recall for Component Failure

    ArthroCare Medical Corporation is recalling EVAC 70 XTRA plasma wands due to potential component failure that may cause the device to become inoperable.

    Product
    EVAC 70 XTRA with Integrated Cable REF EICA5872-01 Product Usage: PLASMA WAND devices are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including: adenoidectomy, cysts, head, neck, oral,
    Category
    Medical Device
    Distribution
    Distributed nationwide