The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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3576–3600 of 5038

  • SevereFDA (Devices)·Z-3034-2017·2017-08-23

    Cenorin ThermaSure Medical Device Dryers Recalled for Overheating Terminal Block

    Cenorin, LLC is recalling 18 ThermaSure Series 1000 medical device dryers because a manufacturing defect causes the terminal block to overheat, char, or burn.

    Product
    ThermaSure(TM), a CENORIN(TM) product, SERIES 1000 MEDICAL DEVICE DRYER: (a) Model 1009; (b) Model 1010 Forced air dryer for medical devices
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3037-2017·2017-08-23

    Boston Scientific Recalls Emblem S-ICD Devices Due to Energy Delivery Risk

    Boston Scientific is recalling approximately 16,750 Emblem S-ICD devices because they may deliver atypical energy levels due to internal memory corruption.

    Product
    EMBLEM S-ICD, Model A209, Subcutaneous Implantable Cardioverter Defibrillator, RX. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradyc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3039-2017·2017-08-23

    Boston Scientific Recalls SQ-RX 1010 Pulse Generators Due to Memory Corruption

    Boston Scientific is recalling approximately 12,450 SQ-RX 1010 Pulse Generators because memory corruption may cause the device to deliver an atypical amount of energy.

    Product
    SQ-RX 1010 Pulse Generator, Rx. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontan
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2099-2017·2017-08-16

    Cook Medical Recalls Zenith Alpha Thoracic Endovascular Grafts

    Cook Medical is recalling Zenith Alpha Thoracic Endovascular Grafts due to reports of graft thrombosis and occlusion, including one patient death.

    Product
    Zenith Alpha Thoracic Endovascular Graft The Zenith Alpha" Thoracic Endovascular Graft is indicated for the endovascular treatment of patients with isolated lesions of the descending thoracic aorta (not including dissections) having vascular anatomy suitable for endovascular r
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2779-2017·2017-08-09

    Myelotec Video Guided Catheters Recalled for Defective Access Port Body

    Myelotec, Inc. is recalling 2,980 Video Guided Catheters because a defective Access Port Body component can cause the port to become obstructed or blocked.

    Product
    Myelotec Video Guided Catheters, REF 2010 3.0 mm OD x 30 Cm Working Length, Two 1.3mm Working Channels
    Category
    Medical Device
    Distribution
    5 states
  • CriticalFDA (Devices)·Z-2737-2017·2017-08-02

    Maquet CS 100 Intra-Aortic Balloon Pump Recalled Due to Device Failure

    Maquet Datascope is recalling 12,319 CS 100 Intra-Aortic Balloon Pumps because electrical and autofill failures prevented the device from initiating therapy, which has been associated with a patient death.

    Product
    CS 100 Intra-Aortic Balloon Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2736-2017·2017-08-02

    Maquet CS 100i Intra-Aortic Balloon Pump Recalled Due to Device Failure

    Maquet Datascope is recalling 12,319 CS 100i Intra-Aortic Balloon Pumps because electrical failures prevented the device from initiating therapy, which has been associated with a patient death.

    Product
    CS 100i Intra-Aortic Balloon Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2738-2017·2017-08-02

    Maquet CS 300 Intra-Aortic Balloon Pump Recalled Due to Device Failure

    Maquet Datascope is recalling 12,319 CS 300 Intra-Aortic Balloon Pumps because electrical test failures caused the device to fail to pump, which has been associated with a patient death.

    Product
    CS 300 Intra-Aortic Balloon Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2702-2017·2017-07-26

    Penumbra 3D Revascularization Device Recalled Due to Delivery Wire Breakage Risk

    Penumbra Inc. is recalling 155 units of the 3D Revascularization Device because a raw material issue could cause the delivery wire to break, potentially leading to serious injury or death.

    Product
    Penumbra 3D Revascularization Device It is indicated for used in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral-M1 and M2 segments) within 8 hours of symptom onse
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2740-2017·2017-07-26

    Flowonix Recalls Prometra II Pump After Reported Fatal Overdose During MRI

    Flowonix Medical is recalling Prometra II implantable infusion pumps after a report of a fatal drug overdose during an MRI procedure.

    Product
    PROMETRA II Programmable Infusion Pump, Implantable Infusion Pump, Catalog Number/REF 13827, Part Number PL-31790-02. Manufactured by: Flowonix Medical Inc., --- The correction involves the labeling of the device plus the following Prometra II pump labeling is also being revise
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2751-2017·2017-07-26

    BD 3ml Syringes Recalled for Insufficient Sterilization Irradiation

    Becton Dickinson is recalling 648,000 units of BD 3ml Syringes because several lots did not receive the specified dose of irradiation required to meet the Sterility Assurance Level.

    Product
    BD 3ml Syringe Luer-Lok" Tip Catalog 309657 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2752-2017·2017-07-26

    BD 10mL Syringes Recalled for Insufficient Sterilization Irradiation

    Becton Dickinson is recalling 547,600 units of BD 10mL Syringes because several lots did not receive the specified dose of irradiation required to meet Sterility Assurance Level standards.

    Product
    BD 10mL Syringe Luer-Lok Tip Catalog number 301997 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2657-2017·2017-07-12

    CardioTek EP-TRACER Software Recalled for Unintentional Parameter Changes

    CardioTek BV is recalling EP-TRACER Software V1.x and V2.0 due to a bug that allows parameters to be changed unintentionally during use.

    Product
    CardioTek EP-TRACER Software V1.x and V2.0 The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. The system allows the user to
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2639-2017·2017-07-05

    DeRoyal Dolphin Inflation Device Recalled for Sterility Assurance Defect

    DeRoyal Industries is recalling 426 Dolphin Inflation Devices due to a primary packaging defect that may compromise sterility.

    Product
    DeRoyal(R) Dolphin Inflation Device, REF 0185ND, Rx Only, STERILE EO, Dolphin is an inflation device indicated during angioplasty procedures to inflate and deflate the balloon catheter, and control pressure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2617-2017·2017-06-28

    DePuy Mitek LATARJET Drill Tip Recall Due to Breakage Risk

    DePuy Mitek is recalling LATARJET Coracoid Top Hat Drills because the Combo Screw Driver tip may break during surgery.

    Product
    DePuy Mitek LATARJET EXPERIENCE Coracoid Top Hat Drill Product Code: 288202 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft
    Category
    Medical Device
    Distribution
    8 states
  • SevereFDA (Devices)·Z-2616-2017·2017-06-28

    DePuy Mitek LATARJET Coracoid Drill Recalled for Breakage Risk

    DePuy Mitek is recalling LATARJET Coracoid Drills because the Combo Screw Driver tip may break during surgery.

    Product
    DePuy Mitek LATARJET EXPERIENCE Coracoid Drill Product Code: 288201 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft
    Category
    Medical Device
    Distribution
    8 states
  • SevereFDA (Devices)·Z-2529-2017·2017-06-21

    Boston Scientific Steerable Sheath Recalled for Sterility Assurance Issues

    Creganna Medical Devices is recalling 85 units of Boston Scientific Zurpaz Steerable Sheaths due to a lack of sterility assurance.

    Product
    Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004USTMCA85200
    Category
    Medical Device
    Distribution
    1 state