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

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All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

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

Clear filters

19076–19100 of 27647

  • HighFDA (Devices)·Z-0050-2018·2017-11-01

    Nucletron Oncentra Brachy 4.5 Software Recalled for Incorrect Source Step Size

    Nucletron BV is recalling Oncentra Brachy 4.5 radiation therapy software because incorrect source step sizes may occur in treatment plans.

    Product
    Oncentra Brachy 4.5 radiation therapy software The firm name on the label is Nucletron B.V. Oncentra is a radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0048-2018·2017-11-01

    GORE TAG Thoracic Endoprosthesis Recalled for Incomplete Deployment Risk

    W.L. Gore & Associates is recalling 12,197 GORE TAG Thoracic Endoprosthesis units worldwide due to a risk of incomplete or partial deployment during endovascular procedures.

    Product
    GORE TAG, THORACIC ENDOPROSTHESIS, CONFORMABLE. The GORE TAG Thoracic Endoprosthesis is intended for endovascular repair of all lesions of the descending thoracic aorta.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0023-2018·2017-10-25

    St. Jude Medical Recalls Infinity 5 and 7 Implantable Pulse Generators

    St. Jude Medical is recalling 3,119 Infinity 5 and 7 Implantable Pulse Generators because battery longevity estimations may be inaccurate.

    Product
    Infinity 5 Implantable Pulse Generator and Infinity 7 Implantable Pulse Generator Models 6660, 6661, 6662, 6663
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0031-2018·2017-10-25

    St Jude Medical Recalls Assurity MRI Pacemakers for Firmware Update

    St Jude Medical is recalling 164,366 Assurity MRI pacemakers to install new firmware that mitigates the risk of unauthorized access via radio frequency communications.

    Product
    Assurity MRI Model Numbers: PM1272, PM2272 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0040-2018·2017-10-25

    Genesys Binary Screwdriver Recalled Due to Threaded Shaft Breakage

    Genesys Orthopedics is recalling 120 Binary Screwdrivers because the threaded inner shaft tip can break off during cervical screw insertion.

    Product
    Genesys spine, Binary Screwdriver, GCP221, component of the Binary Anterior Cervical Plating System The Genesys Spine Binary Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an…
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0032-2018·2017-10-25

    St. Jude Medical Recalls Merlin PCS 3650 Programmer for Firmware Update

    St. Jude Medical is recalling 10,453 Merlin PCS 3650 programmers worldwide to install new firmware that mitigates the risk of unauthorized access to pacemakers.

    Product
    Merlin PCS 3650 Programmer with Model 3330 Software Version 23.1.1 The Merlin Patient Care System (PCS) Model 3650 Programmer is a portable, dedicated programming system designed to interrogate program display data and test St. Jude Medical implantable devices.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0038-2018·2017-10-25

    St Jude Medical Recalls Pacemakers for Firmware Security Update

    St Jude Medical is recalling 2,726 implantable pacemakers to install new firmware that mitigates the risk of unauthorized access via radio frequency communications.

    Product
    PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0037-2018·2017-10-25

    St Jude Medical Recalls PM 1260 Assurity+ Pacemakers for Firmware Update

    St Jude Medical is recalling 6,051 PM 1260 Assurity+ pacemakers to install new firmware that mitigates the risk of unauthorized access via radio frequency communications.

    Product
    PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0034-2018·2017-10-25

    St Jude Medical Recalls Nuance Pacemakers for Firmware Update

    St Jude Medical is recalling 2,741 Nuance pacemakers to install new firmware that mitigates the risk of unauthorized access to the devices' radio frequency communications.

    Product
    PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0033-2018·2017-10-25

    St. Jude Medical Recalls Merlin@Home Software for Pacemaker Security

    St. Jude Medical is recalling Merlin@Home software to mitigate the risk of unauthorized access to pacemakers using radio frequency communications.

    Product
    Merlin@Home Software Model EX2000 v8.2.2 for Merlin@Home Transmitter Models EX1150, EX1150W, EX1100, and EX1100W. The Merlin@home Transmitters are a component of St. Jude Medicals (SJM) Remote Care System. These Merlin@home transmitters are used to retrieve information from…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0022-2018·2017-10-25

    St. Jude Medical Recalls Proclaim Elite Implantable Pulse Generators

    St. Jude Medical is recalling 28,817 Proclaim 5 and 7 Elite Implantable Pulse Generators because battery longevity estimations may be inaccurate.

    Product
    Proclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite Implantable Pulse Generator Models 3660, 3661, 3662, 3663, 3665, 3667
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0030-2018·2017-10-25

    St Jude Medical Recalls Pacemakers for Unauthorized Access Risk

    St Jude Medical is recalling specific Assurity and Accent pacemaker models to mitigate the risk of unauthorized access via radio frequency communications.

    Product
    Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Accent Model Numbers: PM1210, PM2210, PM1222, PM2212; Accent MRI Model Numbers: PM1224, PM2218, PM2224 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0036-2018·2017-10-25

    St Jude Medical Recalls ZENEX Pacemakers for Firmware Update

    St Jude Medical is recalling 4,828 ZENEX pacemakers to install new firmware that mitigates the risk of unauthorized access via radio frequency communications.

    Product
    PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0029-2018·2017-10-25

    St Jude Medical Recalls Pacemakers for Unauthorized Access Risk

    St Jude Medical is recalling specific Anthem and Allure/Relieve pacemakers to mitigate the risk of unauthorized access via radio frequency communications.

    Product
    Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, PM3224, PM3244 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0035-2018·2017-10-25

    St Jude Medical Recalls 101 Implantable Pacemakers for Firmware Update

    St Jude Medical is recalling 101 implantable pacemaker pulse generators to install new firmware that mitigates the risk of unauthorized access via radio frequency communications.

    Product
    PM1226 ACCENT ST MRI SR RF and PM2222 ACCENT ST These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0026-2018·2017-10-25

    CareFusion Recalls Alaris Pump Modules Due to Flow Rate Variations

    CareFusion 303, Inc. is recalling Alaris Pump Module model 8100 units due to reports of increased or decreased medication flows.

    Product
    Alaris Pump Module model 8100 manufactured between November 2011 and March 2012; Alaris Pump Module serviced with LVP Mechanism Sub Assembly (P/N) 10942012 between November 2011 and March 2012; Alaris Pump module Bezel Kit Assembly (P/N) 10964559) shipped between November…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0025-2018·2017-10-25

    Medtronic Recalls VCLAS Laser Applicators Due to Saline Leakage Testing Defect

    Medtronic is recalling 423 VCLAS laser applicator systems because they were not appropriately tested for saline leakage during manufacturing.

    Product
    VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0003-2018·2017-10-18

    St Jude Medical Recalls Fortify ICDs Due to Premature Battery Depletion

    St Jude Medical is recalling approximately 90,563 Fortify and Fortify Assura implantable cardioverter defibrillators because they may exhibit premature battery depletion.

    Product
    Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Numbers: CD1241-40 and CD1241-40Q; Fortify Assura VR, Model Numbers: CD1257-40, CD1257-40Q, CD1357-40C, CD1357-40Q; Fortify Assura ST VR, Model Numbers: CD1263-40, CD1263-40Q, CD1363-40C, CD1363-40Q…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0004-2018·2017-10-18

    St Jude Medical Recalls Unify Cardiac Resynchronization Therapy Defibrillators

    St Jude Medical is recalling specific Unify and Quadra Assura cardiac resynchronization therapy defibrillators because they may exhibit premature battery depletion.

    Product
    Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: CD3249-40 and CD3249-40Q; Unify Assura, Model Numbers: CD3257-40, CD3257-40Q, CD3357-40C, CD3357-40Q; Quadra Assura, Model Numbers: CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q; Quadra Assura MP, Model…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0013-2018·2017-10-18

    Handicare A-Series Patient Lifts Recalled for Premature Strap Wear

    Handicare is recalling 8 A-Series patient lifts because the lift straps may wear prematurely at maximum load, posing a risk of patient drop.

    Product
    PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0014-2018·2017-10-18

    Handicare Recalls Carina Mobile Lifts Due to Small Locking Pin

    Handicare AB is recalling nine Carina mobile lifts because they were delivered with locking pins that are too small. This defect may cause increased wear on internal components.

    Product
    Carina Mobile Lifts, Models: a) Carina350EM, REF 6060011 b) Carina350EML, REF 60600012 c) Carina350EE, REF 60600009
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0011-2018·2017-10-18

    Abbott ARCHITECT c4000 Cuvette Segment Recall for Potential False Results

    Abbott is recalling 1,385 ARCHITECT c4000 cuvette segments because a detached post may cause falsely depressed patient results in adjacent cuvettes.

    Product
    ARCHITECT c4000 Cuvette Segment, List number 02P75-01. The firm name on the label is Abbott Laboratories, Abbott Park, IL. Cuvette segments are a component to the ARCHITECT c4000 system. Cuvette segments are racks that sit in the reaction carousel and hold cuvettes. Each…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0006-2018·2017-10-11

    Permobil Electric Wheelchair Bases Recalled for Top Plate Assembly Failure

    Permobil is recalling 146 electric wheelchair bases due to a potential failure of the top plate assembly that connects the seating system to the base.

    Product
    Electric Wheelchair bases: a) C300 b) C350 c) C400 d) C500
    Category
    Medical Device
    Distribution
    Distributed nationwide