The Recall Desk

Hazard

Device Malfunction recalls

1,800 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,800
Critical
31
Severe
370
Most recent
2026-09-02

Of the 1,800 device malfunction recalls we have scored against our rubric, 31 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 370 (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 device 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.

851–875 of 1800

  • HighFDA (Devices)·Z-1368-2021·2021-04-14

    Medtronic A610 Clinician Programmer Software Recall for Deep Brain Stimulation

    Medtronic is recalling A610 Clinician Programmer software versions 2.0.4584, 2.0.4594, 2.0.4605, and 3.0.1057 due to software errors that prevent proper copying of cycling settings and cause application crashes when reading full system event logs.

    Product
    A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Programming Guide Percept PC Model B35200 Neurostimulator Application, version 2.0.4584, 2.0.4594, 2.0.4605, and 3.0.1057* * Version 3.0.1057 is approved for distribution in Europe only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1306-2021·2021-04-07

    Medtronic Recalls CRT-D Devices Due to Shortened Replacement Time

    Medtronic is recalling specific CRT-D implantable cardioverter defibrillators because a small percentage may experience a shortened time before the device reaches end of service.

    Product
    Implantable cardioverter defibrillators (ICD) with cardiac resynchronization therapy (CRT-D): 1) Viva family: Viva XT CRT-D, Viva XT Quad CRT-D, Viva S CRT-D, Viva Quad S CRT-D and Viva Quad C CRT-D models; 2) Claria family: Claria MRI CRT-D and Claria MRI Quad CRT-D models; 3)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1309-2021·2021-04-07

    CareFusion Recalls BD Alaris Infusion Pump Keypads Due to Fluid Ingress

    CareFusion is recalling BD Alaris Infusion Pump Module Keypads and Door Assembly Kits because fluid ingress can cause unresponsive or stuck keys, potentially delaying medication infusion.

    Product
    BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad; and Pump Module Door Assembly Replacement Kit with Pump Module Keypad, Parts: 49000239; 49000346; 49000438; 49000439.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1278-2021·2021-03-31

    Baxter Recalls Prismaflex Control Units Due to Tubing Performance Variability

    Baxter Healthcare is recalling 1,225 Prismaflex Control Units used for Continuous Renal Replacement Therapy because tubing performance variability may cause alarms during or after system self-tests.

    Product
    Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1277-2021·2021-03-31

    Baxter Recalls Prismaflex Control Units Due to Tubing Performance Variability

    Baxter Healthcare is recalling Prismaflex Control Units because tubing variability may cause alarms during self-tests. The units are used for Continuous Renal Replacement Therapy.

    Product
    Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1279-2021·2021-03-31

    Baxter Recalls Prismaflex Control Units Due to Tubing Performance Variability

    Baxter Healthcare is recalling 1,650 Prismaflex Control Units used for renal replacement therapy because tubing performance variability may cause alarms during or after system self-tests.

    Product
    Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1181-2021·2021-03-17

    Getinge Flow i Anesthesia Systems Recalled for Absorber Docking Failures

    Getinge Group Logistics America is recalling 144 Flow i Anesthesia Systems due to complaints of incorrect FiCO2 readings and System Check Out failures when docking the absorber.

    Product
    Anesthesia gas-machine - Product Usage: intended for use in administering anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting patients with limited ability to breathe.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1123-2021·2021-02-24

    Baxter Recalls Gambro Hemodialysis Blood Sets Due to Kinked Lines

    Baxter Healthcare is recalling Gambro Cartridge Low Weight-Low Volume Blood Transport Systems for hemodialysis because of complaints regarding kinked access lines observed during treatment.

    Product
    Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set, product code 114435 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1120-2021·2021-02-24

    Baxter Gambro Cartridge Blood Transport System Recalled for Kinked Lines

    Baxter Healthcare is recalling Gambro Cartridge Blood Transport Systems for hemodialysis due to complaints of kinked access lines observed during treatment.

    Product
    Gambro Cartridge Blood Transport System for Hemodialysis Blood Set, product code 106289 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1104-2021·2021-02-17

    Draegar Infinity Acute Care System Recall for Random Reboot Defect

    Draegar Medical Systems is recalling Infinity Acute Care System monitors that may randomly reboot due to a memory error, potentially interrupting patient monitoring.

    Product
    Infinity Acute Care System (IACS) Monitoring Solution: The IACS is intended for multi-parameter, physiologic patient monitoring of adult, pediatric and neonatal patients in environments where patient care is provided by trained healthcare professionals.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1105-2021·2021-02-17

    BEMER Therapy Systems Recalled for Potential Interference with Pacemakers and Insulin Pumps

    BEMER International AG is recalling Bemer-Set and Pro-Set therapy systems because electromagnetic fields may cause technical defects in insulin pumps or pacemaker malfunctions.

    Product
    Bemer-Set/ Pro-Set for the following models: REF. 410201 (BEMER Pro-Set), REF. 420201 (B.BOX Professional), REF. 420100 (B.BOX CLASSIC), REF. 410100 (BEMER Classic-Set), REF. 420200 (B.BOX Professional), and REF. 410200 (BEMER Pro - Set)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0939-2021·2021-02-10

    Baxter Flow Coupler Monitor Recall Due to Battery Recharge Failure

    Baxter Healthcare is recalling 109 Flow Coupler Monitor devices because the battery may lose its ability to be recharged.

    Product
    FLOW COUPLER Monitor Flow Coupler devices are sold in 5 sizes (2.0 mm, 2.5 mm, 3.0 mm, 3.5 mm, 4.0 mm). Implantable device for vascular use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0908-2021·2021-02-03

    Philips Respironics V60 Ventilator Recall for Navigation Ring Issues

    Respironics is recalling 3,752 V60 Ventilators worldwide due to potential navigation ring malfunctions that may cause erratic parameter changes or inoperability.

    Product
    Philips Respironics V60 Ventilator Part Number 1076709 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0891-2021·2021-02-03

    Philips Respironics V60 Ventilator Recall for Backup Battery Failure Risk

    Respironics is recalling 3,752 V60 Ventilators worldwide due to a risk of backup battery failure if over-discharged or stored without AC power.

    Product
    Philips Respironics V60 Ventilator Part Number 1076709 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0905-2021·2021-02-03

    Philips Respironics V60 Ventilator Recalled for Navigation Ring and Liquid Ingress Issues

    Respironics is recalling V60 Ventilators because the navigation ring may malfunction or cause erratic parameter changes, and liquid may enter the device.

    Product
    Philips Respironics V60 Ventilator Part Number 1053616 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0889-2021·2021-02-03

    Philips Respironics V60 Ventilator Recall for Backup Battery Failure Risk

    Respironics is recalling 46,313 V60 Ventilators worldwide due to a risk of backup battery failure if over-discharged or stored without AC power.

    Product
    Philips Respironics V60 Ventilator Part Number 1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0907-2021·2021-02-03

    Philips Respironics V60 Ventilator Recalled for Navigation Ring Defects

    Respironics is recalling 534 V60 Ventilators worldwide due to navigation ring malfunctions that may cause erratic parameter changes or inoperability.

    Product
    Philips Respironics V60 Ventilator Part Number 1053618 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0915-2021·2021-02-03

    Philips Respironics V60 Plus Ventilator Recalled for Navigation Ring Issues

    Respironics is recalling V60 Plus ventilators because the navigation ring may fail or cause erratic parameter changes.

    Product
    Philips Respironics V60 Plus Ventilator Part Number 1138747 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0888-2021·2021-02-03

    Philips Respironics V60 Ventilator Recalled for Backup Battery Failure Risk

    Respironics is recalling 330 V60 Ventilators because the backup battery may fail if over-discharged or stored without AC power for extended periods.

    Product
    Philips Respironics V60 Ventilator Part Number 1053616 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0912-2021·2021-02-03

    Philips Respironics V60 Ventilator Recalled for Navigation Ring Defects

    Respironics is recalling 216 V60 Ventilators because the navigation ring may fail or cause erratic parameter changes.

    Product
    Philips Respironics V60 Ventilator Part Number 1076717 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0906-2021·2021-02-03

    Philips Respironics V60 Ventilator Recalled for Navigation Ring Defect

    Respironics is recalling V60 Ventilators because the navigation ring may malfunction or cause erratic parameter changes.

    Product
    Philips Respironics V60 Ventilator Part Number 1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0894-2021·2021-02-03

    Philips Respironics V60 Ventilator Recalled for Backup Battery Failure Risk

    Respironics is recalling 10,441 V60 Ventilators because the backup battery may fail if over-discharged or stored without AC power for extended periods.

    Product
    Philips Respironics V60 Ventilator Part Number 1076716 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0909-2021·2021-02-03

    Philips Respironics V60 Ventilator Recall for Navigation Ring Defects

    Respironics is recalling three V60 ventilators because the navigation ring may malfunction or cause erratic parameter changes.

    Product
    Philips Respironics V60 Ventilator Part Number R1053618 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide