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.

276–300 of 881

  • HighFDA (Devices)·Z-1451-2021·2021-04-28

    Biotronik ITREVIA 7 Defibrillators Recalled for Premature Battery Depletion

    Biotronik is recalling 499 ITREVIA 7 defibrillators due to a potential for premature battery depletion. The devices are distributed nationwide and worldwide.

    Product
    BIOTRONIK ITREVIA 7, VR-T DF-1, REF 393040, UDI: 04035479129552 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1453-2021·2021-04-28

    BIOTRONIK IPERIA 7 ICDs Recalled for Premature Battery Depletion

    BIOTRONIK Inc is recalling 2,881 IPERIA 7 ICDs and CRT-Ds due to a potential for premature battery depletion.

    Product
    BIOTRONIK IPERIA 7, DR-T DF4 ProMRI, REF 392423, UDI: 04035479128913 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1452-2021·2021-04-28

    Biotronik ITREVIA 7 Defibrillators Recalled for Premature Battery Depletion

    Biotronik is recalling 670 ITREVIA 7 defibrillators due to a potential for premature battery depletion. The devices are distributed nationwide and worldwide.

    Product
    BIOTRONIK ITREVIA 7, VR-T DF-4, REF 393041, UDI: 04035479129569 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1457-2021·2021-04-28

    Biotronik ILIVIA 7 ICDs Recalled for Premature Battery Depletion

    Biotronik is recalling 914 ILIVIA 7 ICDs due to a potential for premature battery depletion. The devices are distributed nationwide and worldwide.

    Product
    BIOTRONIK ILIVIA 7, VR-T DF-1 ProMRI, REF 404625, UDI: 04035479142124 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1449-2021·2021-04-28

    BIOTRONIK IPERIA 7 ICDs Recalled for Premature Battery Depletion

    BIOTRONIK Inc is recalling 3,832 IPERIA 7 ICDs and CRT-Ds due to a potential for premature battery depletion. The devices are distributed nationwide and worldwide.

    Product
    BIOTRONIK IPERIA 7,VR-T, DX, DF-1, ProMRI, REF 393032, UDI: 04035479129477 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1442-2021·2021-04-28

    Biotronik Ilestro 7 DR-T Recall for Premature Battery Depletion

    Biotronik is recalling Ilestro 7 DR-T implantable defibrillators due to a potential for premature battery depletion. Affected devices are distributed nationwide and worldwide.

    Product
    BIOTRONIK Ilestro 7 DR-T, DF-4, REF383564, UDI: 04035479125202 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1464-2021·2021-04-28

    Biotronik ILIVIA NEO 7 DR-T DF-1 ProMRI Defibrillators Recalled for Battery Depletion

    Biotronik is recalling 98 ILIVIA NEO 7 DR-T DF-1 ProMRI defibrillators due to a potential for premature battery depletion.

    Product
    BIOTRONIK ILIVIA NEO 7 DR-T DF-1 ProMRI, REF 429529, UDI: 04035479156749 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1450-2021·2021-04-28

    Biotronik ITREVIA 7 Defibrillators Recalled for Premature Battery Depletion

    Biotronik is recalling 386 ITREVIA 7 implantable defibrillators due to a potential for premature battery depletion.

    Product
    BIOTRONIK ITREVIA 7, VR-T DX DF-1, REF 393037, UDI: 04035479129521 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1461-2021·2021-04-28

    Biotronik ILIVIA 7 Defibrillators Recalled for Premature Battery Depletion

    Biotronik Inc is recalling 1,547 ILIVIA 7 defibrillators due to a potential for premature battery depletion. The devices are distributed nationwide and worldwide.

    Product
    BIOTRONIK ILIVIA 7, DR-T DF-1 PROMRI, REF 404622, UDI: 04035479142094 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1334-2021·2021-04-07

    CF Delivery Dev Caps Bravo x5 Recalled for Aspiration Risk

    FDA recalls CF Delivery Dev Caps Bravo x5 capsules because they may fail to attach to the esophagus, leading to aspiration.

    Product
    CF Delivery Dev Caps Bravo x5, FGS-0635/FGS 0636 - Product Usage: intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1335-2021·2021-04-07

    FDA Recalls Bravo pH Capsule Delivery Devices Due to Aspiration Risk

    The FDA is recalling Bravo pH Capsule Delivery Devices because the capsule may fail to attach to the esophagus, leading to aspiration and potential hospitalization.

    Product
    BRAVO PH CAPS DELIVERY DEV5-PK, FGS-0312/FGS-0313 - Product Usage: intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1305-2021·2021-04-07

    Medtronic Recalls Implantable Cardioverter Defibrillators Due to Shortened Replacement Time

    Medtronic is recalling specific Evera and Visia ICD models because a small percentage may experience a shortened Recommended Replacement Time to End of Service interval.

    Product
    Implantable cardioverter defibrillators (ICD): 1) Evera family: Evera XT DR, Evera S DR, Evera MRI XT DR, Evera MRI S DR, Evera XT VR, Evera S VR and Evera MRI S VR models; 2) Visia family: Visia AF ICD, Visia AF S ICD, Visia AF MRI ICD, and Visia AF MRI S ICD models. Impla
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0318-2021·2021-04-07

    Ferring Recalls ZOMA-Jet 10 Demonstration Kits Due to Defective Delivery System

    Ferring Pharmaceuticals is recalling 1,569 ZOMA-Jet 10 Demonstration Kits because the injector pen may break apart and disintegrate into pieces.

    Product
    ZOMA-Jet 10 Demonstration Kit, Needle-free delivery device for use with ZOMACTON (somatropin) for injection 10 mg vial, ZOMA-Jet 10 Demonstration Kit contains -ZOMA-Jet 10 device - 7 Needle-Free Head A's - 1 Carrying Case - 1 User Manual; Manufactured for: Ferring Pharmaceuticals
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0317-2021·2021-04-07

    Ferring Recalls ZOMA-Jet 5 Demonstration Kits Due to Defective Delivery System

    Ferring Pharmaceuticals is recalling 301 ZOMA-Jet 5 Demonstration Kits because the injector pen may break apart and disintegrate into pieces.

    Product
    ZOMA-Jet 5 Demonstration Kit, Needle-free delivery device for use with ZOMACTON (somatropin) for injection 5mg vial, Rx only, ZOMA-Jet 5 Demonstration Kit contains -ZOMA-Jet 5 device - 5 Needle-Free Head A's - 2 Vial Adaptors - 1 Carrying Case - 1 User Manual; Manufactured for: F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1112-2021·2021-02-24

    Combat Medical Systems Recalls Low Titer Type O FWB Transfusion Sets

    Combat Medical Systems, LLC is recalling 1021 units of Low Titer Type O FWB Transfusion Sets due to the potential for bent or disconnected needles in the components.

    Product
    Low Titer Type O FWB Transfusion Set (P/N 80-875 NSN 651501684994). Blood convenience kit. The Transfusion Set includes the items necessary to administer the collected blood to a patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1102-2021·2021-02-17

    Baxter IV Catheter Extension Set Recalled for Tubing Separation

    Baxter Healthcare is recalling 66,800 units of ONE-LINK Non-DEHP Y-Type Microbore Catheter Extension Sets due to reports of tubing separation from the Male Luer Lock Adaptor.

    Product
    Baxter ONE-LINK Non-DEHP Y-Type Microbore Catheter Extension Set, Bonded Needle-free IV Connector, Neutral Fluid Displacement, 5.7 " (14 cm), REF 7N8370K - Product Usage: intended for single patient use with a vascular access device for the administration of drugs and solutions w
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0946-2021·2021-02-10

    Medtronic HVAD Pump Implant Kits Recalled for Startup Failures

    Heartware, Inc. is recalling 19,562 Medtronic HVAD Pump Implant Kits because they may fail to start or restart at a higher rate than expected.

    Product
    Medtronic HVAD Pump Implant Kits, labeled as: a. PUMP 1103, b. PUMP 1104, c. PUMP 1104JP, d. PUMP 1100, e. Model 1101, f. Model 1102, g. Model 1104CA-CLIN, h. Model 1205, i. Model MCS1705PU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0945-2021·2021-02-10

    Mar-Med Tourni-Cot Universal Non-Pneumatic Tourniquet Recalled for Tearing Risk

    Mar-Med Co is recalling 52,000 Tourni-Cot Universal non-pneumatic tourniquets because they may tear during removal, leaving a portion in place that can constrict blood vessels and cause digit ischemia.

    Product
    Tourni-Cot - Universal, UDI 00855364004085, Model Number TCU, Non-pneumatic Tourniquet - Product Usage: The device is intended to be used in surgery on fingers or toes to provide a blood-less field.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0940-2021·2021-02-10

    Biomeme PCR Thermocycler Recalled Due to Software Error Preventing Test Completion

    Biomeme, Inc. is recalling 147 Franklin Real-Time PCR Thermocycler systems because a software error causes instrument failure, preventing users from completing 2019-nCoV tests.

    Product
    Nucleic acid-based in vitro diagnostic devices for the detection of 2019-novel coronavirus (2019-nCoV) and/or diagnosis of 2019-nCoV infection in human clinical specimens. The RT-PCR test runs on a Franklin Real-Time PCR Thermocycler Device (Reference/Catalog Number 1000003,10000
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0935-2021·2021-02-03

    Boston Scientific Recalls Emblem S-ICD Pulse Generators Due to Battery Depletion

    Boston Scientific is recalling 7,093 Emblem S-ICD pulse generators because accelerated battery depletion may require earlier device replacement.

    Product
    EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0928-2021·2021-02-03

    Medtronic Cobalt DR MRI SureScan Defibrillators Recalled for Potential Loss of Function

    Medtronic is recalling two specific MRI SureScan defibrillators because a component failure could cause the device to lose function.

    Product
    Medtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional implantable dual chamber cardioverter defibrillator with SureScan technology and Bluetooth wireless telemetry (DDE-DDDR)
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0868-2021·2021-01-27

    Laerdal Compact Suction Unit Recalled for Potential Suction Loss

    Laerdal Medical is recalling 5,035 Compact Suction Units (LCSU 4) because component failures may cause the device to lose suction, potentially delaying treatment or causing suffocation.

    Product
    Laerdal Compact Suction Unit (LCSU 4), Catalog Numbers 880051, 880061, 881151, 880052, 880062, 881152 - Product Usage: It is intended for intermittent operation to remove secretions, blood or vomit from a patient s airway to allow ventilation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0774-2021·2021-01-13

    Boston Scientific Recalls AXIOS Stent Delivery System Due to Fitting Detachment Risk

    Boston Scientific is recalling 32 units of the AXIOS Stent and Electrocautery - Enhanced Delivery System because a fitting may detach, risking peritonitis.

    Product
    AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm UPN: M00553650 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0662-2021·2020-12-30

    Boston Scientific Recalls IcePearl Cryoablation Needles Due to Gas Leaks

    Boston Scientific is recalling 261 IcePearl 2.1 CX L 90° Cryoablation Needles nationwide due to a complaint trend regarding needle shaft gas leaks.

    Product
    IcePearl" 2.1 CX L 90¿ Cryoablation Needle
    Category
    Medical Device
    Distribution
    Distributed nationwide