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.

126–150 of 1800

  • SevereFDA (Devices)·Z-1943-2025·2025-06-25

    Dexcom G6 Glucose Receiver recalled for missed audible alerts

    Dexcom G6 Glucose Receiver units may have defective foam or assembly errors that disable audible alerts for dangerously low or high blood glucose, risking seizures, loss of consciousness, or death.

    Product
    Dexcom G6 Glucose Receiver, SKUs (Part Number): STK-FM-001 (MT27408-1) & STK-FR-001 (MT27408-1)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1977-2025·2025-06-25

    Fitbone Trochanteric Nail may bend during insertion and require replacement

    Orthofix Srl is recalling Fitbone Trochanteric Nails (Lot B4771336 and B4771337) because the implant may bend at the distal tail during insertion, potentially requiring replacement.

    Product
    REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1865-2025·2025-06-18

    Z-800 Infusion System recalled for unverified software installation

    Zyno Medical LLC is recalling 613 units of the Z-800 Infusion System distributed nationwide because unreleased software versions were installed on the devices without verification or validation.

    Product
    Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1964-2025·2025-06-18

    Baxter Novum IQ Syringe Pump Design Issue Recall

    Baxter is recalling certain Novum IQ Syringe Pumps manufactured or repaired after July 4, 2023, due to a design issue that may falsely detect a syringe flange when none is loaded, causing the pump interface to become stuck or display a System Error 21502.

    Product
    Baxter Novum IQ Syringe Pump, product code 40800BAXUS,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1926-2025·2025-06-18

    DxI 9000 Access Immunoassay Analyzer software version 1.20 recall

    Beckman Coulter is recalling certain DxI 9000 Access Immunoassay Analyzers due to incorrect motor/encoder and cable installation that causes error codes, prevents assays from running, and delays result generation.

    Product
    DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions 1.20
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1816-2025·2025-06-04

    Affinity 4 Birthing Bed Recalled for Faulty Actuator Signal Wires

    Baxter Healthcare is recalling Affinity 4 Birthing Beds due to improper crimps on actuator signal wires that could prevent the bed or foot section from lowering. The defect affects 164 units distributed worldwide.

    Product
    Affinity 4 Birthing Bed, Product Codes P3700E100429, P3700E100432, P3700E100433, P3700E100434, P3700E100435, P3700E100436, P3700E100437, P3700E100438, P3700E100439, P3700E100441, P3700E100442, P3700E100443, P3700E100444, P3700E100445, P3700E100446, P3700E100448, P3700E100449, P37
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1756-2025·2025-05-28

    Bard Blakemore Esophageal-Nasogastric Tube difficult balloon inflation

    C.R. Bard is recalling Bard Blakemore Esophageal-Nasogastric Tubes (Adult) because users may find it difficult or impossible to remove the plastic plugs needed to inflate the gastric and esophageal balloons.

    Product
    Bard Blakemore Esophageal-Nasogastric Tube (Adult) REF: 0092100
    Category
    Medical Device
    Distribution
    52 states
  • SevereFDA (Devices)·Z-1758-2025·2025-05-28

    Bard Blakemore Esophageal-Nasogastric Tube Intermediate Balloon Inflation Difficulty

    C.R. Bard Inc is recalling Bard Blakemore Esophageal-Nasogastric Tubes (Intermediate, REF 0092300) due to reports that plastic plugs may be difficult or impossible to remove, preventing proper inflation of the gastric and/or esophageal balloons.

    Product
    Bard¿ Blakemore Esophageal-Nasogastric Tube (Intermediate)REF: 0092300
    Category
    Medical Device
    Distribution
    52 states
  • SevereFDA (Devices)·Z-1757-2025·2025-05-28

    Bard Blakemore Esophageal-Nasogastric Tube Child Difficult Plug Removal

    C.R. Bard is recalling Bard Blakemore Esophageal-Nasogastric Tubes (Child) due to customer complaints that plastic plugs may be difficult or impossible to remove, preventing inflation of the gastric and esophageal balloons.

    Product
    Bard¿ Blakemore Esophageal-Nasogastric Tube (Child) REF: 0092110
    Category
    Medical Device
    Distribution
    52 states
  • SevereFDA (Devices)·Z-1759-2025·2025-05-28

    Bard Single Intragastric Linton Balloon Tube difficult plastic plug removal

    C.R. Bard Inc is recalling the Bard Single Intragastric Linton Balloon Tube (REF: 0092740) because users may be unable or find it difficult to remove plastic plugs needed to inflate the gastric and esophageal balloons.

    Product
    Bard¿ Single Intragastric Linton Balloon Tube, REF: 0092740
    Category
    Medical Device
    Distribution
    52 states
  • SevereFDA (Devices)·Z-1755-2025·2025-05-28

    Bard Minnesota Four Lumen Esophagogastric Tamponade Tube Recalled

    C.R. Bard Inc is recalling the Bard Minnesota Four Lumen Esophagogastric Tamponade Tube (REF:0092220) because users may be unable to or have difficulty removing plastic plugs needed to inflate the gastric and esophageal balloons.

    Product
    Bard Minnesota Four Lumen Esophagogastric Tamponade Tube, REF:0092220 18 Fr. (6mm, 7/32"), 41" Length (104cm) with 8" (20.3cm) Balloon X-Ray Opaque Rubber
    Category
    Medical Device
    Distribution
    52 states
  • SevereFDA (Devices)·Z-1760-2025·2025-05-28

    Centerline Biomedical IOPS Guidewire 2 Coating Delamination Risk

    Centerline Biomedical is recalling the IOPS Guidewire 2 (Lot 2404-2005) because the coating may delaminate during use, potentially compromising the guidewire's function during catheter placement procedures.

    Product
    Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a catheter
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-1762-2025·2025-05-21

    Tornado Embolization Microcoil recalled for incorrectly sized coils

    Cook Incorporated is recalling Tornado Embolization Microcoils due to incorrectly sized coils in affected lots. The devices are used for vascular embolization procedures.

    Product
    Tornado Embolization Microcoil, intended for embolization of selective vessel supply to arteriovenous malformations and other vascular lesions, RPN MWCE-18S-3/2-TORNADO (GPN G08261), RPN MWCE-18S-3/2-TORNADO-081800 (GPN G13102), RPN MWCE-18S-4/2-TORNADO (GPN G08357)
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-1668-2025·2025-05-14

    CADD-Solis VIP Ambulatory Infusion Pump False Occlusion Alarm Recall

    Smiths Medical is recalling CADD-Solis VIP Ambulatory Infusion Pumps due to false Upstream Occlusion Alarms that may interrupt medication infusions, risking serious patient injury or death.

    Product
    CADD-Solis VIP Ambulatory Infusion Pump; Model/Number: 21-2120-0100-02 21-2120-0100-03 21-2120-0100-06 21-2120-0100-232 21-2120-0100-233 21-2120-0100-50 21-2120-0100-51 21-2120-0100-95 21-2120-0102-02 21-2120-0102-03 21-2120-0102-06 21-2120-0102-07 21-2120-0102-0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1625-2025·2025-05-07

    GE Healthcare CARESTATION 620 A2 Anesthesia System Ventilation Failure

    Certain GE Healthcare CARESTATION anesthesia systems may fail to provide effective ventilation in Volume Control Ventilation (VCV) mode. Alternative ventilation modes or manual ventilation can be used.

    Product
    GE Healthcare CARESTATION 620 A2, Model/REF Number 1012-9620-002. Anesthesia system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1630-2025·2025-05-07

    GE Healthcare Anesthesia Systems Recalled Over Ventilation Failure

    GE Healthcare is recalling certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems because they may not provide effective ventilation in Volume Control Ventilation (VCV) mode. The issue does not affect Pressure Control Ventilation (PCV), PCV-VG, or manual ventilation modes.

    Product
    GE Healthcare Carestation 650 SE, Model/REF Number 1012-9650-012. Anesthesia system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1635-2025·2025-05-07

    GE Healthcare CARESTATION 750 Anesthesia System Volume Control Ventilation Failure

    Certain GE Healthcare CARESTATION 750 anesthesia systems may fail to provide effective ventilation in Volume Control Ventilation mode. Affected systems can deliver ventilation through alternative modes or manual ventilation.

    Product
    GE Healthcare CARESTATION 750 A1, Model/REF Number 1012-9750-000. Anesthesia system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1627-2025·2025-05-07

    GE Healthcare Anesthesia Systems Recalled Over Ventilation Failure

    GE Healthcare is recalling certain Carestation 620/650/650c and 750/750c anesthesia delivery systems because they may not provide effective ventilation in Volume Control Ventilation (VCV) mode. The issue does not affect Pressure Control Ventilation (PCV), PCV-VG, or manual ventilation modes.

    Product
    GE Healthcare Carestation 620 A1, Model/REF Number 1012-9620-200. Anesthesia system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1637-2025·2025-05-07

    GE Healthcare CARESTATION 750c A1 Anesthesia System Ventilation Defect

    GE Healthcare CARESTATION 750c A1 anesthesia systems may not provide effective ventilation in Volume Control Ventilation mode. Affected units can achieve ventilation through alternative modes or manual operation.

    Product
    GE Healthcare CARESTATION 750c A1, Model/REF Number 1012-9755-000. Anesthesia system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1704-2025·2025-05-07

    Enhanced Verify Evaluation Handset May Fail to Connect to Neurostimulator

    Medtronic Enhanced Verify Evaluation Handsets (CFN HH90130FA) may fail to communicate with neurostimulators due to faster processing speed, causing therapy to stop and patients to experience return of underlying symptoms.

    Product
    Enhanced Verify Evaluation Handset (CFN HH90130FA)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1689-2025·2025-05-07

    IceSeed 1.5 CX Cryoablation Needles Recalled for Incorrect Software Settings

    Boston Scientific is recalling IceSeed 1.5 CX cryoablation needles manufactured between April 2024 and February 2025 due to incorrect software programming. Affected needles may prompt unnecessary Needle Integrity and Functionality Tests if disconnected and reconnected during use.

    Product
    IceSeed 1.5 CX NEEDLE OUS, Cryoablation Needle, REF H7493967534170. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1687-2025·2025-05-07

    Boston Scientific IceSeed CX Cryoablation Needles Incorrectly Programmed

    Boston Scientific is recalling IceSeed 1.5 CX S cryoablation needles manufactured April 2024 to February 2025 that were programmed with DEMO instead of Commercial settings. If disconnected and reconnected after initial testing, the system will re-prompt testing rather than functioning normally.

    Product
    IceSeed 1.5 CX S NEEDLE OUS, Cryoablation Needle, REF H7493967334100. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1657-2025·2025-04-30

    Globus Medical MAGEC 2 Rod recalled for incorrect outer diameter assembly

    Globus Medical is recalling MAGEC 2 Rod model MC2-5090S devices because certain units were assembled with a 5.5mm outer diameter rod instead of the required 5.0mm specification.

    Product
    MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1666-2025·2025-04-30

    Tempus Pro Patient Monitor software error when using video laryngoscope

    Remote Diagnostic Technologies Ltd. is recalling Tempus Pro Patient Monitors due to a software issue that causes an error screen when a video laryngoscope is attached to the device.

    Product
    Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headset dock), 00-1007-R and 00-1007 (Tempus Pro non-printer, IBP, with headset dock), 00-1024-R (Tempus Pro printer), 00-1026-R (Tempus Pro printer, IBP), 00-1007 [(Tempus Pro, BT Dock (IB Only)],
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1533-2025·2025-04-23

    AutoPulse NXT Resuscitation System may fail to provide chest compressions

    ZOLL Circulation, Inc. is recalling the AutoPulse NXT Resuscitation System Model 200 because the device may not provide adequate chest compressions or may stop compressions due to an error code FC1060.

    Product
    Brand Name: AutoPulse NXT Resuscitation System Product Name: AutoPulse NXT Platform Model/Catalog Number: Model 200 (Catalog Number: 8700-001070-1) Software Version: Version 2.0.1 Product Description: The AutoPulse Resuscitation System Model 200 is an automated, portable, bat
    Category
    Medical Device
    Distribution
    19 states