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 the agency’s own highest classification or reported deaths or serious injuries, 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.

Filters

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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

Category

All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

16301–16325 of 27500

  • SevereFDA (Devices)·Z-0821-2019·2019-02-20

    Elekta MOSAIQ Oncology System Recalled for Potential Radiation Dose Errors

    Elekta is recalling MOSAIQ Oncology Information Systems because missing wedge IDs may cause patients to receive higher radiation doses than planned.

    Product
    MOSAIQ¿ Oncology Information System and Sequencer MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0830-2019·2019-02-20

    AtriCure Recalls COBRA FUSION 150 Ablation System Due to Thromboembolism Risk

    AtriCure is recalling 6,176 units of the COBRA FUSION 150 Ablation System because patients may face an elevated risk of thromboembolism during specific off-pump procedures.

    Product
    COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001
    Category
    Medical Device
    Distribution
    37 states
  • SevereFDA (Devices)·Z-0832-2019·2019-02-20

    AtriCure COBRA FUSION 150 Ablation System Recalled for Thromboembolism Risk

    AtriCure is recalling 765 units of the COBRA FUSION 150 Ablation System due to a potential elevated risk of thromboembolism during specific off-pump procedures.

    Product
    COBRA FUSION 150 Ablation System (International Only), Catalog # (REF) 700-001MI
    Category
    Medical Device
    Distribution
    37 states
  • SevereFDA (Devices)·Z-0809-2019·2019-02-20

    Medtronic SENSIA Dual Chamber Pacemaker Recall for Circuit Error

    Medtronic is recalling SENSIA dual chamber pacemakers due to a potential circuit error that may affect device functionality when programmed to specific modes.

    Product
    Medtronic implantable pulse generator: SENSIA, Dual chamber pacemaker (DDD): (a) Model Number SED01 (b) Model Number SEDR01 (c) Model Number SEDRL1
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0808-2019·2019-02-20

    Medtronic Pacemaker Recall: Circuit Error Affects Dual Chamber Functionality

    Medtronic is recalling 7,469 dual chamber pacemakers worldwide due to a circuit error that may affect device functionality when programmed to specific modes.

    Product
    Medtronic implantable pulse generator: RELIA, Dual chamber pacemaker (VDD): (a) Model Number RED01 (b) Model Number REDR01 (c) Model Number REVDD01
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0806-2019·2019-02-20

    Medtronic Adapta Dual Chamber Pacemaker Recall for Circuit Error

    Medtronic is recalling specific Adapta, Versa, and Sensia dual chamber pacemakers due to a circuit error that may affect device functionality.

    Product
    Medtronic implantable pulse generator: ADAPTA, Dual chamber pacemaker (DDD): (a) Model Number ADD01 (b) Model Number ADDR01 (c) Model Number ADDR03 (d) Model Number ADDR06 (e) Model Number ADDRL1 (f) Model Number ADDRS1 (g) Model Number ADVDD01
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0824-2019·2019-02-20

    Steris ATLAS Loading Car Recalled for Latch Failure Risk

    Steris Corporation is recalling 129 ATLAS Loading Cars because the latch may fail to engage when empty, causing the unit to slide or fall.

    Product
    ATLAS Loading Car
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0829-2019·2019-02-20

    AtriCure Recalls COBRA FUSION 50 Ablation Systems Due to Thromboembolism Risk

    AtriCure is recalling 1,288 COBRA FUSION 50 Ablation Systems because patients may face an elevated risk of thromboembolism during specific off-pump procedures.

    Product
    COBRA FUSION 50, Ablation System, Catalog # (REF) 700-002
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Devices)·Z-0612-2019·2019-02-20

    Philips CombiDiagnost R90 X-ray System Recalled for Radiation Dose Risk

    Philips is recalling 146 CombiDiagnost R90 X-ray systems because a software defect may cause patients to receive increased radiation doses.

    Product
    Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stationary Fluoroscopic X-ray System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0812-2019·2019-02-20

    Medtronic Pacemaker Recall for Potential Circuit Error in Dual Chamber Mode

    Medtronic is recalling specific dual chamber pacemakers due to a circuit error that may affect device functionality when programmed to atrial-sensing mode.

    Product
    vitatron (implantable pulse generator): (a) A-series, Model Numbers: A30A1, A60A1 (b) E-series, Model Numbers: E50A1, E60A1 (c) G-series, Model Numbers: G70A1, G70A2 (d) Q-series, Model Numbers: Q50A2, Q70A2, Q80A2
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0811-2019·2019-02-20

    Medtronic Pacemaker Recall for Potential Circuit Error in Dual Chamber Mode

    Medtronic is recalling specific Versa, Adapta, and Sensia pacemakers distributed worldwide from 2017 to 2019 due to a potential circuit error that may affect device functionality.

    Product
    Medtronic implantable pulse generator: Versa, Dual chamber rate responsive pacemaker (DDDR), Model Number VEDR01
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0831-2019·2019-02-20

    AtriCure Recalls COBRA FUSION 150 Ablation System Due to Thromboembolism Risk

    AtriCure is recalling 175 units of the COBRA FUSION 150 Ablation System because patients may face an elevated risk of thromboembolism during specific off-pump procedures.

    Product
    COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001S
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Devices)·Z-0835-2019·2019-02-20

    Edwards Commander Delivery System Recalled for Balloon Component Separation

    Edwards Lifesciences is recalling the Edwards Commander Delivery System due to reports of crimp and inflation balloon component separation during TAVR procedures.

    Product
    Edward Lifesciences, Edwards Commander Delivery System: Model Number UDI Number 9600LDS20A (US) 00690103193930 9600LDS20J 00690103194852 9600LDS23A (US) 00690103193947 9600LDS23J 00690103194869 9600LDS26A (US) 00690103193954 9600LDS26J 00690103194876 9600LDS29A (US)…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0810-2019·2019-02-20

    Medtronic Sphera DR MRI SureScan Pacemakers Recalled for Circuit Error

    Medtronic is recalling specific Sphera DR MRI SureScan pacemakers worldwide due to a circuit error that may affect device functionality when programmed to dual chamber mode.

    Product
    Medtronic implantable pulse generator: Sphera DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number SPDR01 (b) Model Number SPDRL1
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0837-2019·2019-02-20

    OMNI K1 Broach Handle Recalled Due to Loose Inner Pin Risk

    OMNIlife science Inc. is recalling seven OMNI K1 Broach Handles because the inner pin may become loose and fall out.

    Product
    OMNI K1 Broach Handle, Product Code HS-10054
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0825-2019·2019-02-20

    Hemotherm CE Dual Reservoir Cooler/Heater Recalled for Overheating Risk

    Cincinnati Sub-Zero is recalling 396 Hemotherm CE Dual Reservoir Cooler/Heater units because fuse clips may stretch, causing overheating and device shutdown.

    Product
    Hemotherm CE Dual Reservoir Cooler/Heater, Model No. 400CE Product Usage: The HEMOTHERM¿ Model 400CE Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the temperature of the water flowing through a Blood Oxygenator / Heat Exchanger that is used to cool or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0834-2019·2019-02-20

    Signature Orthopedics Recalls Three Genius Knee Cemented CR Femoral Components

    Signature Orthopedics is voluntarily recalling three Genius Knee Cemented CR Femoral Components due to a product mix-up. The devices were distributed in Florida, New York, and Tennessee.

    Product
    Genius Knee Cemented CR Femoral Component Product Usage: Knee replacement component
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0807-2019·2019-02-20

    Medtronic Pacemaker Recall for Potential Circuit Error in Dual Chamber Mode

    Medtronic is recalling specific dual chamber pacemakers distributed worldwide between 2017 and 2019 due to a potential circuit error affecting device functionality.

    Product
    Medtronic implantable pulse generator: ATTESTA L DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number ATDR01 (b) Model Number ATDRL1 (c) Model Number ATDRS1
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0836-2019·2019-02-20

    Magstim HORIZON Ez Arm Recalled for Protruding Stainless-Steel Cable Strand

    The Magstim Company Limited is recalling 27 HORIZON Ez Arm units because a stray stainless-steel cable strand may protrude from the heat shrink sleeving on the Balance Cable.

    Product
    HORIZON Ez Arm (Part of the HORIZON TMS Therapy System.)
    Category
    Medical Device
    Distribution
    8 states
  • CriticalFDA (Devices)·Z-0711-2019·2019-02-13

    Smiths Medical Recalls Portex Sterile Water Humidifiers Due to Leaking

    Smiths Medical is recalling Portex 550 ml Sterile Water Humidifiers because leaking containers may compromise sterility, potentially exposing patients to infectious agents.

    Product
    Portex 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0710-2019·2019-02-13

    Smiths Medical Recalls Portex Sterile Water Humidifiers Due to Leaking

    Smiths Medical is recalling Portex 350 ml Sterile Water Humidifiers because leaking containers may expose patients to infectious agents.

    Product
    Portex 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0715-2019·2019-02-13

    Smiths Medical Recalls Portex Sterile Water Humidifiers Due to Leaking

    Smiths Medical is recalling Portex 550 ml Sterile Water Humidifiers because leaking containers may compromise sterility, potentially exposing patients to infectious agents.

    Product
    Portex 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿¿ ¿¿¿ ¿¿¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0722-2019·2019-02-13

    Medline Prefilled 550 ml Sterile Bags Recalled for Leaking

    Medex Cardio-Pulmonary Inc. is recalling 54,924 Medline Prefilled 550 ml Sterile bags due to leaking containers that may compromise sterility.

    Product
    Medline Prefilled 550 ml Sterile¿¿ ¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0787-2019·2019-02-13

    CoaguChek XS PT Test Strips Recalled for Abnormally High INR Results

    Terrific Care LLC is recalling CoaguChek XS PT Test Strips sold via MedEx Supply due to potential for abnormally high INR test results.

    Product
    CoaguChek XS PT Test; All Catalog/REF Numbers that do NOT end in 160 The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System is intended for properly selected and suitably trained users or their caregivers on the prescription or other…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0712-2019·2019-02-13

    Smiths Medical Recalls Portex Sterile Water Pour Bottles Due to Leaking

    Smiths Medical is recalling Portex 1000 ml Sterile Water USP Pour Bottles because leaking containers may lack sterility assurance, posing a risk of exposure to infectious agents.

    Product
    Portex 1000 ml Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿
    Category
    Medical Device
    Distribution
    Distributed nationwide