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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3026–3050 of 5111

  • 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-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-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
  • 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-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 a
    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 order
    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-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-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
  • 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-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
  • SevereFDA (Devices)·Z-0717-2019·2019-02-13

    Medline Sterile Water Humidifier Recalled for Leaking Containers

    Smiths Medical is recalling Medline sterile water humidifiers because leaking containers may expose patients to infectious agents.

    Product
    Medline 300-350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0802-2019·2019-02-13

    Arjohuntleigh RotoProne Therapy System Recalled for Buckle Release Issue

    Arjohuntleigh is recalling 231 RotoProne Therapy Systems because the proning arm buckle may be difficult to release, potentially delaying emergency patient access.

    Product
    ARJOHUNTLEIGH GETINGE GROUP, RotoProne Therapy System, Model Number 209800
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0713-2019·2019-02-13

    Smiths Medical Recalls Portex Sterile Water Pour Bottles Due to Leaking

    Smiths Medical is recalling Portex 500 ml Sterile Water USP Pour Bottles because leaking containers may compromise sterility and expose users to infectious agents.

    Product
    Portex 500 ml Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0718-2019·2019-02-13

    Medline Prefilled 350 ml Sterile Solution Recall Due to Leaking

    Medex Cardio-Pulmonary Inc. is recalling 235,560 units of Medline Prefilled 350 ml Sterile Solution because leaking containers may compromise sterility and expose patients to infectious agents.

    Product
    Medline Prefilled 350 ml Sterile¿¿¿¿ ¿¿¿¿ ¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0714-2019·2019-02-13

    Smiths Medical Recalls Intermed 350 ml Sterile Water Humidifiers

    Smiths Medical is recalling Intermed 350 ml Sterile Water Humidifiers due to leaking containers that may compromise sterility and expose patients to infectious agents.

    Product
    Intermed 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿ ¿¿¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0765-2019·2019-02-06

    Edwards Lifesciences Recalls Swan Ganz Catheters Due to Lumen Reversal

    Edwards Lifesciences is recalling 459 Swan Ganz Thermodilution Catheters because incorrect lumen assembly causes reversed pressure readings, potentially leading to misdiagnosis.

    Product
    Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 151F7 Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determine hemodynamic pressures and cardiac output when used with a compatible cardiac output computer.
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0764-2019·2019-02-06

    Edwards Lifesciences Recalls Swan Ganz Catheters Due to Lumen Assembly Error

    Edwards Lifesciences is recalling 9 units of Swan Ganz Thermodilution Catheters because incorrect lumen assembly causes reversed pressure readings.

    Product
    Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131VF7P Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determine hemodynamic pressures and cardiac output when used with a compatible cardiac output computer
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0767-2019·2019-02-06

    West Pharma Vial2BAG DC 13mm Recalled for Adverse Events

    West Pharma Services IL, Ltd. is recalling Vial2BAG DC 13mm devices due to reported adverse events and potential inadequate drug admixing.

    Product
    Vial2BAG DC 13mm, REF 6070111, Single use only, Rx Only
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0763-2019·2019-02-06

    Edwards Lifesciences Recalls Swan Ganz Catheters Due to Lumen Reversal

    Edwards Lifesciences is recalling 875 units of Swan Ganz Thermodilution Catheters because incorrect lumen assembly causes reversed pressure readings.

    Product
    Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131F7P (5 pack of 131F7) Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determine hemodynamic pressures and cardiac output when used with a compatible cardiac o
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0737-2019·2019-01-30

    Draeger Medical Recalls VentStar Basic 250 Breathing Circuits Due to Assembly Error

    Draeger Medical is recalling 170 units of VentStar Basic 250 breathing circuits because they were incorrectly pre-assembled, creating a risk of incorrect connection or short circuiting.

    Product
    VentStar Basic 250, Catalog Number MP00350 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only. Breathing Circuits/Anesthesia Sets with
    Category
    Medical Device
    Distribution
    12 states
  • SevereFDA (Drugs)·D-0384-2019·2019-01-30

    Recall of Curaplex Epi Safe Kits Due to Incorrect Epinephrine Instructions

    Bound Tree Medical is recalling Curaplex Epi Safe Kits because the instructions recommend an unapproved epinephrine dosage for young children.

    Product
    curaplex Epi Safe Kit, 8600-01101, contains:" 1ml Vial of Epinephrine " 1 Epi-Safe Syringe " 1 Safety Needle " 2 Alcohol Prep Pads " 1 Adhesive Dressing " 1 Insert, Rx Only. Distributed by Sarnova HC, LLC s family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Eme
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0739-2019·2019-01-30

    Draeger Medical Recalls VentStar Basic Breathing Circuits Due to Assembly Error

    Draeger Medical is recalling 75 units of VentStar Basic (P) 250 breathing circuits because they were incorrectly pre-assembled, creating a risk of incorrect connection or short circuit.

    Product
    VentStar Basic (P) 250, Catalog Number MP00352 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only. Breathing Circuits/Anesthesia Sets
    Category
    Medical Device
    Distribution
    12 states
  • SevereFDA (Devices)·Z-0754-2019·2019-01-30

    Teleflex Percuvance Percutaneous Shaft Recall Due to Tip Breakage Risk

    Teleflex Medical is recalling 1,962 units of Percuvance Percutaneous Shafts because the distal tip may deform or break off during use, potentially requiring surgical intervention.

    Product
    Percuvance(R) Percutaneous Shaft 36cm, PCVSHL3 The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate Intended Use: soft tissue to access certain areas of the abdomen. The system is used to grasp, manipulate, cut, cauterize and deliver He
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0753-2019·2019-01-30

    Teleflex Percuvance Percutaneous Shaft Recall for Potential Tip Breakage

    Teleflex Medical is recalling Percuvance Percutaneous Shafts because the distal tip may deform or break off during use, potentially compromising the tool's security.

    Product
    Percuvance(R) Percutaneous Shaft 29cm, PCVSH3 The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate Intended Use: soft tissue to access certain areas of the abdomen. The system is used to grasp, manipulate, cut, cauterize and deliver Hem
    Category
    Medical Device
    Distribution
    Distributed nationwide