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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2476–2500 of 5038

  • CriticalFDA (Devices)·Z-1442-2020·2020-03-18

    CME BodyGuard Microset Infusion Sets Recalled for Fluid Under-Delivery

    CME America is recalling BodyGuard Microset infusion sets because they may under-deliver fluids when used with specific infusion pump systems.

    Product
    BodyGuard Microset REF A120-003XYVA, Sterile EO, Tubing: 150 in. (380 cm), Prime Vol: approx. 8ml Product Usage: The BodyGuard Infusion Pump System is designed to transfer medication and fluids intravenously.
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Devices)·Z-1476-2020·2020-03-18

    Qiagen Rotor-Gene Q Software Recall for Incorrect Concentration Reporting

    Qiagen is recalling Rotor-Gene Q instruments with software version 2.3.4 because a bug causes concentration results to be reported as logarithmic values, potentially leading to false negative test results.

    Product
    QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed for rapid thermalcycling and real-time detection of PCR assays.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1427-2020·2020-03-18

    HeartWare HVAD System Battery Charger Recalled for Adapter Insertion Risk

    Heartware, Inc. is recalling 5,489 HeartWare HVAD System Battery Chargers because users may mistakenly insert the AC adapter into the HVAD Controller power port.

    Product
    HeartWare HVAD System Battery Charger The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT)
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1362-2020·2020-03-11

    CareFusion Alaris PCA Module Recalled for Software Errors

    CareFusion 303, Inc. is recalling CareFusion Alaris PCA Module, Model 8120 units due to software errors that may cause infusion interruptions or incorrect medication concentrations.

    Product
    CareFusion Alaris PCA Module, Model 8120
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1415-2020·2020-03-11

    DeRoyal Sterile Custom Kits Recalled for Unknown Bioburden and Contamination

    DeRoyal Industries is recalling 2,100 sterile custom kits containing Cardinal Health gowns due to unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Laparoscopy Pack 89-6138.13
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1430-2020·2020-03-11

    Remisol Advance software recalled for remote code execution vulnerability

    Normand-Info S.A.S.U. is recalling Remisol Advance software running on unsupported Windows operating systems due to a critical remote code execution vulnerability.

    Product
    Remisol Advance running on hardware with Windows XP, Windows 7, Windows Server 2003 and Windows Server 2008 operating systems
    Category
    Medical Device
    Distribution
    51 states
  • SevereFDA (Devices)·Z-1437-2020·2020-03-11

    FDA Recalls LKT200 Perfusion Circuits Due to Leakage Risk

    Organ Recovery Systems is recalling 2,274 LKT200 Perfusion Circuits because leakage at the sample port could cause loss of perfusion solution needed for kidney preservation.

    Product
    LKT200 Perfusion Circuit, part of Lifeport Kidney Perfusion Transporter KTR - Product Usage: The circuit is an accessory to LifePort Kidney Perfusion Transporter (KTR) Isolated kidney perfusion and transport system, which is intended to be used for the continuous hypothermic mach
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1357-2020·2020-03-04

    Medline Lumbar Delivery System Recalled Due to Sterilization Failure

    Medline Industries is recalling 122 units of HOI Lumbar Complete Delivery Systems because the sterile packs did not complete a sterilization cycle, compromising sterility.

    Product
    Medline HOI LUMBAR REF DYNJ902823G Lot 20AKA895 Expiration 2021-05-31 1 each GTIN (01)10193489219180
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1402-2020·2020-03-04

    MicroVention HydroFrame 10 Embolic Coils Recalled for Missing Implant Coil

    MicroVention is recalling 991 HydroFrame 10 and HydroCoil embolic systems because the implant coil may be missing. The devices were distributed outside the United States.

    Product
    MicroVention Terumo HydroFrame 10, HydroCoil Embolic System, Endovascular Embolization Coil, Sterile, Rx, REF numbers 100306HFRM-V, 100405HFRM-V, 100408HFRM-V, 100410HFRM-V, 100412HFRM-V, 100415HFRM-V, 100510HFRM-V, 100515HFRM-V, 100519HFRM-V, 100612HFRM-V, 100619HFRM-V, 100623HF
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1346-2020·2020-03-04

    Siemens COHERENCE Oncologist Software Recall for Incorrect Dose Positioning

    Siemens is recalling COHERENCE Oncologist software due to a calculation error that could lead to incorrect patient repositioning and radiation dose delivery to the wrong location.

    Product
    COHERENCE Oncologist, Model Nos. 07333680 & 07351898
    Category
    Medical Device
    Distribution
    16 states
  • SevereFDA (Devices)·Z-1358-2020·2020-03-04

    Medline Robotic-LF Complete Delivery System Recall Due to Sterility Concerns

    Medline Industries is recalling 122 units of the Robotic-LF Complete Delivery System because the sterile packs did not complete a sterilization cycle, meaning sterility cannot be guaranteed.

    Product
    Medline ROBOTIC-LF REF CDS984543B Lot 20AKA927 Expiration 2020-09-30 GTIN (01)10888277056350
    Category
    Medical Device
    Distribution
    1 state
  • 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 myo
    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 appropri
    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 app
    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 myoca
    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 myoc
    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 appropriat
    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 appropriat
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1138-2020·2020-02-26

    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 1012455-15 Rx Only,NC TREK RX 5.00 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 myoc
    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 myo
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1128-2020·2020-02-26

    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 1012453-08 Rx Only, NC TREK RX 4.00 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 myoc
    Category
    Medical Device
    Distribution
    0 states
  • 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 myo
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0946-2020·2020-02-26

    Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Defect

    Philips Respironics is recalling 105 Trilogy EVO ventilators because a software defect causes inoperative power alarms. The units are distributed internationally but not in the US.

    Product
    Garbin EVO Ventilator, Linde - Model Number: LD2110X23B 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 acces
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0945-2020·2020-02-26

    Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Defect

    Philips Respironics is recalling 48 Trilogy EVO ventilators due to a software defect that causes inoperative power alarms. The units were distributed in 15 countries outside the US.

    Product
    Trilogy EVO Ventilator, EU - Model Number: EU2110X15B 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 accesso
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0953-2020·2020-02-26

    Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Defect

    Philips Respironics is recalling 27 Trilogy EVO ventilators because a software defect causes the loss of all power alarms.

    Product
    Trilogy EVO Ventilator, 02 - EU - Model Number: EU2100X15B 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 ac
    Category
    Medical Device
    Distribution
    0 states