The Recall Desk

Hazard

Device Failure recalls

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

What the numbers show

Total
881
Critical
30
Severe
255
Most recent
2026-09-02

Of the 881 device failure recalls we have scored against our rubric, 30 (3%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 255 (29%) 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 failure 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 881

  • SevereFDA (Devices)·Z-1678-2024·2024-05-22

    Cardiac Catheters Recalled Due to Polyurethane Delamination and Guidewire Advancement Failure

    Boston Scientific is recalling certain Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment, which may prevent proper guidewire advancement during cardiac procedures.

    Product
    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS3.5 (5PK), REF H74908526574A2; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-1692-2024·2024-05-08

    Left ventricular assist system implant kit recalled for potential inflow cannula seal leak

    Thoratec HeartMate 3 left ventricular assist system implant kits may develop a leak at the seal interface between the inflow cannula and titanium apical cuff, potentially compromising device function.

    Product
    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1341-2024·2024-03-27

    Angiodynamics Guidewire Introducer Recall Due to Manufacturing Defect

    Angiodynamics recalls approximately 5,840 guidewire introducers with manufacturing defects that may prevent proper guidewire insertion during vascular procedures. The defect could cause procedural delays requiring equipment exchange.

    Product
    MINI STICK MAX 5F X 10 CM STIFF .018 NI/TU ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-759
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1279-2024·2024-03-20

    D-Clip Surgical Applier Recalled for Failure to Release During Surgery

    FDA has recalled the D-Clip Standard/Mini Applier due to reports that the device failed to release the clip and remained attached during surgical use, creating a risk of surgical complications.

    Product
    D-Clip Standard/Mini Applier, 230mm bayonet, jaw rigid, double action.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1064-2024·2024-03-06

    AirLife Manual Resuscitator Recall Due to Broken Components Preventing Ventilation

    Vyaire Medical is recalling 1,020,330 AirLife Adult Manual Resuscitators due to defective components that can fail to deliver proper ventilation. When components break or disassemble, users may experience hypoventilation or hypoxia, potentially fatal complications.

    Product
    AirLife Adult Manual Resuscitator, Variable Volume Oxygen Reservoir Tubing, Adult Mask, REF 2K8017
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1059-2024·2024-03-06

    AirLife Adult Manual Resuscitator recalled for faulty component causing ventilation failure

    Vyaire Medical is recalling 8,220 AirLife Adult Manual Resuscitators with defective duckbill and ring components. The manufacturing defect may prevent proper ventilation and could lead to hypoxia or death.

    Product
    AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Expiratory Filter, REF 2K8004F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1065-2024·2024-03-06

    AirLife Manual Resuscitator recalled for broken components causing ventilation failure

    Vyaire Medical is recalling approximately 1.8 million AirLife Adult Manual Resuscitators worldwide due to faulty molded components that may fail to deliver proper ventilation, risking hypoventilation and hypoxia.

    Product
    AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8004
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1058-2024·2024-03-06

    AirLife Adult Manual Resuscitator tubing may fail to deliver proper ventilation

    Vyaire Medical is recalling 66,078 units of AirLife Adult Manual Resuscitator oxygen tubing worldwide due to component manufacturing defects that can cause device failure and inadequate ventilation.

    Product
    AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, without Mask, REF 2K8001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1061-2024·2024-03-06

    AirLife Adult Manual Resuscitator Recalled for Ventilation Failure Risk

    Vyaire Medical recalls 3.6 million AirLife Adult Manual Resuscitators due to defective oxygen tubing components that may fail to deliver proper ventilation, risking hypoxia. Affected units were manufactured in 2017 or earlier.

    Product
    AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8005
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1166-2024·2024-03-06

    Medtronic Duet Catheter System Recalled for Potential Disconnection Risk

    Medtronic Duet External Drainage System catheters may disconnect from stopcocks, potentially compromising cerebrospinal fluid management. The FDA Class I recall affects 3,889 units distributed worldwide.

    Product
    Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, REF 46917, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1060-2024·2024-03-06

    AirLife Adult Manual Resuscitator Kits Recalled for Component Failure

    Vyaire Medical is recalling 3,636 AirLife Adult Manual Resuscitator kits. Manufacturing defects can cause component failure that prevents proper ventilation, potentially resulting in fatal hypoxia.

    Product
    AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Adult Mask, CO2 Detector, REF 2K8004C2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1205-2024·2024-03-06

    Colonoscope Model CF-H180AL Recalled Due to Missing Protective Adhesive

    Olympus is recalling 36 colonoscopes with specific serial numbers that lack a protective adhesive, risking device failure if exposed to vibration, temperature changes, or shock loads.

    Product
    Colonoscope, Model Number CF-H180AL.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1192-2024·2024-03-06

    Dental Prosthetic Material Recall for Machining Defects

    GRAPHENANO Dental G-CAM denture manufacturing material is being recalled due to machining errors that render the product unusable. The recall affects 354 units distributed in Utah.

    Product
    GRAPHENANO DENTAL G-CAM, Product Codes: a) 95 Multichroma 14LB2, REF GC00089; b) 95 Multichroma 24LA2, REF GC00112; c) 95 Multichroma 20LA1, REF GC00130; d) 95 Multichroma 24LC2, REF GC00090; e) 95 Multichroma 24LA1, REF GC00113; f) 95 Multichroma 16LB2, REF GC00131;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0942-2024·2024-02-07

    EZDilate Wire Guided Balloon Recalled for Device Malfunction and Patient Injury Risk

    Olympus recalled 3,767 EZDilate Wire Guided Balloons due to reported inflation, deflation, and retrieval problems causing bursting, leaking, and foreign body lodgement in patients. The devices dilate strictures in the alimentary tract.

    Product
    EZDilate Wire Guided Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years). Model: BD-410X-1555
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0938-2024·2024-02-07

    EZDilate Fixed Wire Balloon Medical Device Recalled Due to Device Failures

    Olympus is recalling 8,294 EZDilate Fixed Wire Balloon devices due to reports of device failures including bursting, leaking, and foreign body retention in patients undergoing esophageal dilation.

    Product
    EZDilate Fixed Wire Balloon 18-19-20. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-2080
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0832-2024·2024-02-07

    Ophthalmic procedural kits recalled due to inadequate sterilization validation

    American Contract Systems is recalling 940 ophthalmic surgical kits nationwide due to undocumented components that may lack functionality, drug efficacy, or contain elevated sterilization residuals.

    Product
    Custom procedural convenience kits and trays, Ophthalmic use, labeled as: a) EYE PACK, kit number LVEY27; b) Laminectomy, kit number UIOL34AG
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0788-2024·2024-01-31

    Power Knee Prosthetic Batteries Recalled Due to Unexpected Shutdown Risk

    Ossur Power Knee prosthetic knee batteries may fail to turn on or shut down unexpectedly, potentially causing users to lose support and fall. Affected units are distributed nationwide.

    Product
    Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0581-2024·2023-12-27

    Exactech Novation Hip System Recalled for Vacuum Seal Loss

    Exactech is recalling the Novation Hip System due to loss of vacuum in the sterile packaging. The company has received complaints about this defect affecting 4 devices.

    Product
    Exactech Novation Hip System, Catalog Numbers: 134-36-45
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-0504-2024·2023-12-13

    Medical Catheter Sets Recalled Due to Bonding Material Defect

    CooperSurgical H/S Catheter Sets may have defective bonding material causing component detachment or leakage. The sets are used in hysterosalpingography procedures to detect uterine abnormalities.

    Product
    CooperSurgical H/S CATHETER SET FR 5 with Integated Stylet Model: 61-4005S For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology such as polyps, fibroids, adhesions or endometrial thickening, and/or patency of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0353-2024·2023-11-29

    BioFire FilmArray TORCH power switch may fail from electrical arcing

    BioFire FilmArray TORCH diagnostic devices have a power switch that may degrade from internal arcing and carbon buildup, potentially causing electrical short, device overheating, or failure to power on.

    Product
    FilmArray TORCH REF HTFA-ASY-0104. HTFA-ASY-0104 is the BIOFIRE TORCH Base which includes barcode scanner, touch screen computer and USB ports. The BioFire FilmArray Torch (BioFire Torch) is an automated in vitro diagnostic (IVD) device intended for use with FDA-cleared or ap
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0179-2024·2023-11-01

    Robotics Pack I.V. Catheter and Adhesive Recalled for Sterilization Defect

    American Contract Systems is recalling its Robotics Pack (56 cases) due to improper sterilization of IV catheter and adhesive components. The devices may have lost functionality or drug efficacy and may contain excessive ethylene oxide residuals.

    Product
    Robotics Pack, REF SSRO22D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0074-2024·2023-10-18

    Flower Orthopedics Cannulated Reamer Recalled for Breaking During Surgical Use

    The FDA is recalling Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer because the device can break during use, potentially requiring revision surgery.

    Product
    Coventus Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer-used to ream and subsequently open the intramedullary canal to the appropriate depth for nail insertion; Flex-Thread TM 3.2mm is provided sterile, single use. Catalogue Number: 8528-1-S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2616-2023·2023-09-27

    PDS Plus Antibacterial Sutures Recalled for Tensile Strength Defect

    Ethicon is recalling PDS Plus Antibacterial sutures from specific lots that failed internal tensile strength testing. The defective sutures could fail during or after surgery, creating a risk of serious patient harm.

    Product
    PDS Plus Antibacterial (polydioxanone) Suture, Product Numbers PDP072H40, PDP259H50, PDP416H50, PDP441H50, PDP442H50, PDP489G50, PDP489H40, PDP497G51, PDP497H16, PDP497H40, PDP498H40, PDP502V05, PDP507V05, PDP510V05, PDP515V05, PDP662H50, PDP663H50, PDP684H40, PDP9615H40, PDP9625
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2600-2023·2023-09-27

    Stryker ACM Cement Mixing System nozzle may break during surgery

    Stryker is recalling ACM Systems due to potential breakage of the femoral nozzle applicator tip during use. This could cause device failure and leave components in the surgical site.

    Product
    Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press-Allows the user to mix bone cement with a constant high vacuum through the process Catalog Number: 0306-573-000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2465-2023·2023-09-06

    LifeSPARC Cardiac Pump Recalled Due to Uncured Epoxy Manufacturing Defect

    Cardiac Assist, Inc. is recalling the LifeSPARC Pump due to uncured epoxy used during manufacturing that may cause early device failure. Two units were distributed in Illinois and Florida.

    Product
    LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray part number: 5800-1000. Note: The 5800-1000 model number is an individually packaged component contained within the Kit numbers: 5830-2916 LS TANDEMLIFE KIT DL29 5840-2417 LS TAND
    Category
    Medical Device
    Distribution
    Distributed nationwide