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.

901–925 of 1800

  • SevereFDA (Devices)·Z-0008-2021·2020-10-07

    Endo GIA Stapler Recall Due to Incomplete Staple Formation

    FDA recalls Endo GIA Auto Suture staplers because staples may not form properly, potentially preventing adequate hemostasis during surgery.

    Product
    Endo GIA Auto Suture Universal Articulating Loading Unit 60 mm - 3.5 mm, Item Code 030458 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3015-2020·2020-10-07

    Stryker IsoAir 2.0 Support Surface Recalled for CPR Connector Defect

    Stryker is recalling 110 IsoAir 2.0 support surfaces because a connector defect may delay CPR during cardiac arrest.

    Product
    Stryker IsoAir 2.0 support surface-provides pressure redistribution and is intended to assist in management of the microclimate of the patient skin, Model Number: 2941-001-100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2984-2020·2020-09-30

    LivaNova Recalls Perceval Single Use Accessory Kits Due to Collapse Failure

    LivaNova is recalling 77 Perceval Single Use Accessory Kits because the Dual Collapser component may fail to reduce the heart valve diameter during implantation.

    Product
    Perceval Single Use Accessory Kit, Size S, REF: ICV1345, Sterile EO, Rx Only, CE, UDI: 8022057015204 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, all
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2882-2020·2020-09-16

    CareFusion Recalls BD Alaris Modules for Incorrect Syringe Display

    CareFusion 303, Inc. is recalling BD Alaris Syringe and PCA Modules because they may display incorrect syringe types or sizes, potentially causing infusion errors.

    Product
    BD Alaris System; Alaris Syringe Module Model 8110; BD Alaris System; Alaris PCA Module Model 8120; BD Alaris System; Syringe/PCA Sizer Sensor Replacement Kit, P/N 122278652
    Category
    Medical Device
    Distribution
    54 states
  • HighFDA (Devices)·Z-2908-2020·2020-09-02

    Neurovision Recalls Cobra x5 2-Ch EMG ET Tubes Due to Insulation Defect

    Neurovision Medical Products Inc is recalling 1,058 Cobra x5 2-Ch EMG ET Tubes because the electrode insulating material may soften, potentially stopping EMG signal transmission.

    Product
    Cobra x5 2-Ch EMG ET Tube, 8.0mm, REF: LTE700DCL-5, Rx Only, Sterile EO UDI: B006LTE700DCL52 - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open airway for patient ventilation during
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2903-2020·2020-09-02

    Neurovision Cobra EMG ET Tube Recalled for Insulating Material Softening

    Neurovision is recalling Cobra x5 EMG ET tubes because the insulating material may soften and damage, potentially stopping EMG signal transmission.

    Product
    Cobra x5 1-CH EMG ET Tube, 6.0mm, REF: LTE700S-5, Rx Only, Sterile EO UDI: B006:TE700S52$$7050918B - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open airway for patient ventilation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2906-2020·2020-09-02

    Neurovision Cobra x5 EMG Endotracheal Tubes Recalled for Insulation Defect

    Neurovision is recalling Cobra x5 EMG endotracheal tubes because the electrode insulation may soften and damage, potentially stopping EMG signal transmission.

    Product
    Cobra x5 2-Ch EMG ET Tube, 6.0mm, REF: LTE700DCS-5, Rx Only, Sterile EO UDI: B006LTE700DCS52/$$7062618C - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open airway for patient ventila
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2907-2020·2020-09-02

    Neurovision Cobra x5 EMG ET Tube Recalled for Insulation Softening

    Neurovision is recalling Cobra x5 2-Ch EMG ET Tubes because the electrode insulating material may soften over time, potentially damaging the device and stopping EMG signal transmission.

    Product
    Cobra x5 2-Ch EMG ET Tube, 7.0mm, REF: LTE700DCM-5, Rx Only, Sterile EO UDI: B006LTE700DCM52 - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open airway for patient ventilation during
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2905-2020·2020-09-02

    Neurovision Cobra EMG Endotracheal Tubes Recalled for Insulation Softening

    Neurovision is recalling Cobra x5 1-Ch EMG ET Tubes because the electrode insulating material may soften over time, potentially damaging the device and stopping EMG signal transmission.

    Product
    Cobra x5 1-Ch EMG ET Tube, 8.0mm, REF: LTE700L-5, Rx Only, Sterile EO UDI: B006LTE700L52$$7061318B - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open airway for patient ventilation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2794-2020·2020-08-19

    Philips HeartStart MRx Monitor/Defibrillators Recalled for Therapy Switch Failure

    Philips is recalling HeartStart MRx monitor/defibrillators because a therapy switch failure may prevent the device from delivering the intended shock energy or function.

    Product
    Philips HeartStart MRx, Monitor/Defibrillators with model numbers M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9 - Product Usage: is intended for use in hospital and pre-hospital settings by qualified medical personnel tra
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2780-2020·2020-08-19

    Maquet Holder HKHZ 19 Recalled for Insecure Oxygenator Fit

    Maquet is recalling Holder HKHZ 19 units for Quadrox-i and Quadrox-iD oxygenators because the holder may not securely hold the oxygenator.

    Product
    Holder HKHZ 19 for use with Quadrox-i and Quadrox-iD Neonatal / Pediatric Oxygenators, Model Number: 701047495 - Product Usage: The Holder HKHZ 19 is an accessory to QUADROX i and QUADROX iD Neonatal / Pediatric oxygenator and is being used as a single holder for QUADROX i and QU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2716-2020·2020-08-12

    CareFusion Alaris System PC Unit Model 8000 Recall for Cleaning Agent Damage

    CareFusion 303, Inc. is recalling Alaris System PC Unit Model 8000 infusion pumps because cleaning agents may damage connectors, causing therapy interruptions.

    Product
    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2721-2020·2020-08-12

    CareFusion Alaris EtCO2 Module Recall Due to Cleaning Agent Damage

    CareFusion 303, Inc. is recalling Alaris EtCO2 Module Model 8300 units because cleaning agents may damage connectors, potentially interrupting infusion therapy or monitoring.

    Product
    Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2722-2020·2020-08-12

    CareFusion Alaris SpO2 Modules Recalled for Cleaning-Related Connector Damage

    CareFusion 303, Inc. is recalling Alaris SpO2 Modules because cleaning agents may damage connectors, causing infusion or monitoring interruptions.

    Product
    Alaris SpO2 Module Model 8210 and Model 8220, a modular infusion pump and monitoring system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2765-2020·2020-08-12

    Boston Scientific Recalls Captivator Polypectomy Snares Due to Cutting Defect

    Boston Scientific is recalling Captivator Polypectomy Snares because they may fail to cut and remove polyps, potentially causing tissue damage or bleeding.

    Product
    Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2719-2020·2020-08-12

    CareFusion Alaris Syringe Module Recall Due to Cleaning Agent Damage

    CareFusion 303, Inc. is recalling Alaris Syringe Module Model 8110 units because cleaning agents may damage connectors, potentially interrupting infusion therapy or monitoring.

    Product
    Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2717-2020·2020-08-12

    CareFusion Alaris System PC Unit Model 8015 Infusion Pump Recall

    CareFusion 303, Inc. is recalling Alaris System PC Unit Model 8015 infusion pumps because cleaning agents may damage connectors, potentially interrupting therapy or monitoring.

    Product
    Alaris System PC Unit Model 8015, a modular infusion pump and monitoring system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2718-2020·2020-08-12

    CareFusion Alaris Pump Module 8100 Recalled for Cleaning Agent Damage

    CareFusion 303, Inc. is recalling Alaris Pump Module Model 8100 units because cleaning agents may damage connectors, causing therapy interruptions.

    Product
    Alaris Pump Module Model 8100, a modular infusion pump and monitoring system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2720-2020·2020-08-12

    CareFusion Alaris PCA Module 8120 Recalled for Cleaning Agent Damage

    CareFusion 303, Inc. is recalling 83,532 Alaris PCA Module Model 8120 units because cleaning agents may damage connectors, causing therapy interruptions.

    Product
    Alaris PCA Module Model 8120, a modular infusion pump and monitoring system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2683-2020·2020-07-29

    Boston Scientific Recalls IceForce 2.1 CX Cryoablation Needles

    Boston Scientific is recalling 656 IceForce 2.1 CX Cryoablation Needles because the needle surface deteriorated due to unexpected electrolysis during procedures.

    Product
    Ablation Galil Technology, IceForce 2.1 CX 90 Cyroablation Needles, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2544-2020·2020-07-15

    Cardinal Health NPWT Canisters Recalled Due to Oversized O-Ring Defect

    Cardinal Health is recalling 1,960 NPWT Occlusion Detection Canisters because an oversized O-ring may prevent proper installation into the device connector.

    Product
    Cardinal Health NPWT Occlusion Detection Canister 300cc, Prescription Only - Product Usage: The systems are intended for use on patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2476-2020·2020-07-15

    Verathon Recalls GlideScope Core OneTouch Smart Cables Due to Connection Defect

    Verathon is recalling 437 GlideScope Core OneTouch Smart Cables because twisting during connection may damage the internal circuit board, causing video loss during critical intubation procedures.

    Product
    GlideScope Core OneTouch Smart Cable, REF: 0800 0601, an accessory to the GlideScope Video Laryngoscope System Per PLRA: The Core OneTouch Cables (Reusable Device) is ancillary equipment used with the Core 10 and Core 15 monitors. The monitor and workstation are intended to w
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2541-2020·2020-07-15

    Abbott Recalls TactiCath Quartz Contact Force Ablation Catheters Due to Data Loss

    Abbott is recalling TactiCath Quartz Contact Force Ablation Catheters because they may lose contact force information during use.

    Product
    TactiCath Quartz Contact Force Ablation Catheter, Model Numbers: PN-004 065 (GTIN 07640157990033) and PN-004 075 (GTIN 07640157990040) - Product Usage: is a multi-electrode irrigated catheter with a deflectable tip designed to allow electrophysiological mapping of the heart and,
    Category
    Medical Device
    Distribution
    0 states