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.

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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

19101–19125 of 27682

  • HighFDA (Devices)·Z-0067-2018·2017-11-15

    Encore Medical Recalls Cobalt Bone Cement Due to Packaging Seal Loss

    Encore Medical, Lp is recalling Cobalt HV with Gentamicin bone cement because the sterile Tyvek packaging may have lost its seal, potentially compromising sterility.

    Product
    Cobalt HV with Gentamicin, Cobalt Bone Cement 40GM, REF 402283, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee and other joints to fix plastic and metal prosthetic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0089-2018·2017-11-15

    Epimed Recalls TUOHY Epidural Needles Due to Potential Sterility Seal Issues

    Epimed International is recalling 263 units of TUOHY Epidural Needles because a partially incomplete seal could impact the product's sterility.

    Product
    TUOHY Epidural Needle, 20g x 3.5in(8.9cm) TW, 10 units, Calibrated, Plastic Hub, Fixed Wing, Sterile, Rx only
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-0059-2018·2017-11-08

    Teleflex Percuvance Percutaneous Surgical System Recalled for Tool Tip Breakage

    Teleflex is recalling specific Percuvance surgical instruments because the tool tip jaws may break, causing fragments to fall off during use.

    Product
    Teleflex(R) Percuvance(TM) Percutaneous Surgical System, Components: (a) 5 mm Atraumatic Johans Grasper, Catalog Number PCVJG5 (b) 5 mm Maryland Dissector, Catalog Number PCVMD5 (c) 5 mm Hem-o-lok Clip Applier, Catalog Number PCVHCA5 (d) 5 mm Traumatic Gripper Grasper…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0058-2018·2017-11-08

    Biosense Webster Recalls THERMOCOOL SF NAV Catheters Due to Display Error

    Biosense Webster is recalling THERMOCOOL SF NAV catheters because a system alert may cause physicians to ablate in unintended areas.

    Product
    THERMOCOOL SF NAV Catheters Model Numbers - BNI35FJCT, BNI35DFCT, D-131503-S, D-131504-S
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0057-2018·2017-11-08

    Biosense Webster Recalls THERMOCOOL Catheters Due to Navigation System Alert

    Biosense Webster is recalling 19 THERMOCOOL catheters because they trigger a false magnetic distortion alert on the CARTO 3 System, potentially leading to unintended ablation.

    Product
    THERMOCOOL SMARTTOUCH Uni-Directional Navigation Catheter (D133602S)
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0056-2018·2017-11-08

    Biosense Webster Recalls THERMOCOOL SMARTTOUCH Navigation Catheters

    Biosense Webster is recalling 64 THERMOCOOL SMARTTOUCH catheters because they may trigger a false magnetic distortion alert on the CARTO 3 System, potentially leading to unintended ablation.

    Product
    THERMOCOOL SMARTTOUCH Bi-Directional Navigation Catheter (D-132704-S, D-132705-S)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0052-2018·2017-11-08

    Bios THERMI250 Radiofrequency System Recalled for Unintended Energy Emission

    Bios S.r.l. is recalling 167 THERMI250 Radiofrequency Systems because they may continue to emit RF energy after the PAUSE button is pressed.

    Product
    THERMI250 Radiofrequency System. Intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions.
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-0054-2018·2017-11-08

    Biosense Webster Recalls THERMOCOOL Catheters Due to System Alert Error

    Biosense Webster is recalling THERMOCOOL catheters because they may trigger a false magnetic distortion alert on the CARTO 3 System, potentially leading to unintended ablation.

    Product
    THERMOCOOL SMARTTOUCH SF Uni-Directional Product Codes D-1347-01-S, D-1347-02-S, D-1347-03-S
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0062-2018·2017-11-08

    Smiths Medical Recalls CADD Medication Cassette Reservoirs with Incorrect Pressure Plate

    Smiths Medical ASD Inc. is recalling CADD Medication Cassette Reservoirs because some units may have been manufactured with an incorrect pressure plate.

    Product
    CADD(TM) Yellow Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included., REF 21-7100-24, 100mL, For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps).STERILE EO, Smiths Medical ASD, Inc. For use with CADD(R) pumps…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0055-2018·2017-11-08

    Biosense Webster Recalls THERMOCOOL Catheters Due to Magnetic Distortion Alert

    Biosense Webster is recalling THERMOCOOL catheters because they may trigger a false magnetic distortion alert on the CARTO 3 System, potentially leading to unintended ablation.

    Product
    THERMOCOOL SMARTTOUCH SF Bi-Directional Product Codes D-1348-01-S, D-1348-04-S, D-1348-05-S
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0060-2018·2017-11-08

    Smiths Medical Recalls CADD Medication Cassette Reservoirs with Incorrect Pressure Plates

    Smiths Medical is recalling CADD Medication Cassette Reservoirs because some units may have been manufactured with an incorrect pressure plate.

    Product
    CADD(TM) Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included., 50 mL, For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps)., REF 21-7001-24, STERILE EO, Smiths Medical ASD, Inc. For use with CADD(R) pumps…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0021-2018·2017-11-01

    OriGen Reinforced Dual Lumen Catheter Recalled for Tube Separation

    OriGen Biomedical is recalling 180 units of Reinforced Dual Lumen Catheters because the extension tube may separate from the hub, causing patient injury.

    Product
    The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of the device. A thin sheath is used to cover and secure the wire layer and is heat shrunk into a permanent position.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0043-2018·2017-11-01

    MicroPort Orthopedics Recalls 48 Schanz Screws Due to Seal Defect

    MicroPort Orthopedics is recalling 48 sterile Schanz screws due to an inadequate pouch seal that could compromise sterility and lead to infection.

    Product
    MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0049-2018·2017-11-01

    FDA Requests Removal of Ablatherm Ultrasound System Software Settings

    FDA requested the removal of specific energy treatment settings from 12 Ablatherm ultrasound systems in the U.S. pending clinical data evaluation.

    Product
    Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue Ablation Transrectal high intensity focused ultrasound (HIFU) ablation of prostate tissue
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0044-2018·2017-11-01

    Bard Max-Core Biopsy Instruments Recalled for Malfunction

    Bard Peripheral Vascular Inc is recalling 110,550 Max-Core Disposable Core Biopsy Instruments due to increased complaints of failure to prime, fire, or obtain samples.

    Product
    BARD MAX-CORE Disposable Core Biopsy Instrument, Product Codes - MC1410, 14 g x 10 cm; MC1616, 16 g x 16 cm; MC1816, 18 g x 16 cm; MC1820, 18 g x 20 cm; MC1825, 18 g x 25 cm. The core needle biopsy device is intended for use in obtaining biopsies from soft tissues.
    Category
    Medical Device
    Distribution
    0 states
  • 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