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

Agency

Category

Minimum severity

Clear filters

18001–18025 of 40124

  • ModerateFDA (Devices)·Z-1379-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Data Errors

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because the resulting impression or scanned data may cause incorrect rotation and margin contour misalignment.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 4MM(H) Reference Number: IEHA464
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1349-2020·2020-03-04

    Randox RX Daytona Plus Clinical Chemistry Analyzer Software Recall

    Randox Laboratories is recalling RX Daytona Plus clinical chemistry analyzers to fix software issues causing incorrect sample ordering and quality control flags.

    Product
    RX Daytona Plus (with ISE/without ISE); Models Nos. RX4040 (w/ISE) and RX4041 (without ISE) - Product Usage: A fully automated, random access, clinical chemistry analyzer complete with dedicated analyzer software. For use in clinical laboratories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1363-2020·2020-03-04

    Siemens ADVIA Chemistry Lipase Recalled for Calibration Failures

    Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Lipase reagents due to customer complaints about failed calibrations and increased imprecision in quality control and patient samples.

    Product
    ADVIA Chemistry Lipase, Ref. No. 01984894 B01-4840-01, Siemens Material No. 10311896, UDI 00630414482446 - Product Usage: Lipase measurements are used in the diagnosis and treatment of diseases of the pancreas, such as acute pancreatitis and obstruction of the pancreatic duct.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1382-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Data Errors

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they produce incorrect rotation and margin contour data.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 3MM(H) Reference Number: IEHA553
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1345-2020·2020-03-04

    Philips DigiTrak XT Holter Recorder Software Recall for Malfunction

    Philips is recalling DigiTrak XT Holter Recorders because a software defect causes the device to fail when an AAA battery is present.

    Product
    Philips DigiTrak XT Holter Recorder Software version number B.1 and C.2. The DigiTrak XT Recorder is available in four different configurations. Service tag numbers for these configurations are as follows: - 453564067151 24-Hour Configuration - 453564067161 48-Hour…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1366-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Rotation Error

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they may cause incorrect rotation and margin misalignment in dental impressions.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 3MM(H) Reference Number: IEHA343
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1353-2020·2020-03-04

    Theralase TLC-2000 Laser System Recalled for Low Power Output

    Theralase Inc. is recalling 92 TLC-2000 Therapeutic Medical Laser Systems because the 660 nm laser diodes may be below rated power output.

    Product
    TLC-2000 Therapeutic Medical Laser System
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1389-2020·2020-03-04

    LivaNova SMART PERFUSION PACK INSPIRE 8S Recalled for Incorrect Cuvette Packaging

    LivaNova USA Inc. is recalling 27 SMART PERFUSION PACK INSPIRE 8S units because they were packaged with the incorrect cuvette component.

    Product
    LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected product is a perfusion tubing pack use in surgical procedures requiring extracorporeal support. The perfusion tubing packs include the cuvette used with equipment to monitor blood.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1391-2020·2020-03-04

    Getinge 46-Series Washer Disinfector Recalled Due to Missing Water Intake

    Maquet Cardiovascular is recalling 7 Getinge 46-Series Washer Disinfector units because they lack the necessary water intake components for proper installation.

    Product
    Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-503 Product Usage: Used in facilities such as Central Sterile Supply Departments, next to the Operating Room, in dental clinics or hospital wards to clean, thermally or chemically disinfect and dry surgical…
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Devices)·Z-1390-2020·2020-03-04

    Getinge 46-Series Washer Disinfector Recalled Due to Missing Water Intake Components

    Maquet Cardiovascular is recalling four Getinge 46-Series Washer Disinfector units because they lack necessary water intake components, preventing proper installation.

    Product
    Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-502 Product Usage: Used in facilities such as Central Sterile Supply Departments, next to the Operating Room, in dental clinics or hospital wards to clean, thermally or chemically disinfect and dry surgical…
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Devices)·Z-1354-2020·2020-03-04

    Theralase TLC-2000 Laser System Recalled for Low Power Output

    Theralase Inc. is recalling 92 TLC-2000 Therapeutic Medical Laser Systems because the 905 nm laser diodes may be below rated power output.

    Product
    TLC-2000 Therapeutic Medical Laser System
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1348-2020·2020-03-04

    Theralase TLC-2000 Laser Power Pack Recalled for Battery Testing Deficiency

    Theralase Inc. is recalling 202 TLC-2000 Therapeutic Medical Laser System Power Packs because the internal battery pack was not tested to IEC-60601-1-2 standards.

    Product
    TLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-1135-2020·2020-02-26

    Abbott NC TREK Coronary Dilatation Catheters Recalled for Balloon Deflation Issues

    Abbott Vascular is recalling NC TREK Coronary Dilatation Catheters because the balloon may be difficult or unable to deflate.

    Product
    NC TREK Coronary Dilatation Catheter, REF 1012454-20 Rx Only, NC TREK RX 4.50 X 20MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving…
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0942-2020·2020-02-26

    Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Alarm Defect

    Philips Respironics is recalling 21 Trilogy EVO Ventilators because a software defect causes the loss of all power alarms.

    Product
    Trilogy EVO Ventilator, International, Model Number IN2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the…
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0952-2020·2020-02-26

    Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Defect

    Philips Respironics is recalling specific Trilogy EVO ventilators because a software defect causes power alarms to fail, potentially leaving patients without critical alerts.

    Product
    Trilogy EVO Ventilator, 02 - Iberia - Model Number: ES2100X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the…
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0947-2020·2020-02-26

    Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Alarm Defect

    Philips Respironics is recalling 15 Trilogy EVO Ventilators because a software defect causes the loss of all power alarms.

    Product
    Trilogy EVO Ventilator, Great Britain - Model Number: GB2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the…
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0950-2020·2020-02-26

    Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Defect

    Philips Respironics is recalling 21 Trilogy EVO Ventilators because a software defect causes the loss of all power alarms.

    Product
    Trilogy EVO Ventilator, 02 - International - Model Number: IN2100X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the…
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-1136-2020·2020-02-26

    Abbott NC TREK Coronary Dilatation Catheters Recalled for Deflation Issues

    Abbott Vascular is recalling NC TREK Coronary Dilatation Catheters because the balloon may fail to deflate. The recall covers 39,687 units distributed worldwide.

    Product
    NC TREK Coronary Dilatation Catheter, REF 1012455-08 Rx Only, NC TREK RX 5.00 X 8MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving…
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-1133-2020·2020-02-26

    Abbott NC TREK Coronary Dilatation Catheter Recall for Balloon Deflation Issues

    Abbott Vascular is recalling NC TREK Coronary Dilatation Catheters because the balloon may fail to deflate. The recall covers 39,687 units distributed worldwide.

    Product
    NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50 X 8MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1278-2020·2020-02-26

    FDA Recalls Polysorb Sutures Due to Packaging Integrity Issues

    The FDA is recalling specific lots of Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that could compromise sterility.

    Product
    Polysorb Braided Absorbable Suture 1 30 VIOLET GS-22, Item Code CL885 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1130-2020·2020-02-26

    Abbott NC TREK Coronary Dilatation Catheter Recall for Deflation Issues

    Abbott Vascular is recalling NC TREK Coronary Dilatation Catheters because the balloon may fail to deflate. The recall covers 39,687 units distributed worldwide.

    Product
    NC TREK Coronary Dilatation Catheter, REF 1012453-15 Rx Only, NC TREK RX 4.00 X 15MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1134-2020·2020-02-26

    Abbott Vascular Recalls NC TREK Coronary Dilatation Catheters

    Abbott Vascular is recalling NC TREK RX Coronary Dilatation Catheters because the balloon may have difficulty or inability to deflate.

    Product
    NC TREK Coronary Dilatation Catheter, REF 1012454-15 Rx Only, NC TREK RX 4.50 X 15MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0944-2020·2020-02-26

    Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Alarm Defect

    Philips Respironics is recalling 31 Trilogy EVO Ventilators due to a software defect that causes the loss of all power alarms.

    Product
    Trilogy EVO Ventilator, Germany - Model Number: DE2110X13B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1142-2020·2020-02-26

    Abbott NC Traveler Coronary Dilatation Catheter Recall for Balloon Deflation Issues

    Abbott Vascular is recalling NC Traveler Coronary Dilatation Catheters because the balloon may fail to deflate. The device is not cleared for commercial distribution in the US.

    Product
    NC TRAVELER Coronary Dilatation Catheter, REF 1013157-15, Rx Only,NC Traveler RX 4.0 X 15MM The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United States.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1129-2020·2020-02-26

    Abbott NC TREK Coronary Dilatation Catheters Recalled for Deflation Issues

    Abbott Vascular is recalling NC TREK Coronary Dilatation Catheters because the balloon may be difficult or unable to deflate.

    Product
    NC TREK Coronary Dilatation Catheter, REF 1012453-12 Rx Only, NC TREK RX 4.00 X 12MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving…
    Category
    Medical Device
    Distribution
    0 states