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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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

2026–2050 of 5038

  • SevereFDA (Devices)·Z-1540-2021·2021-05-19

    Meridian Revogene SARS-CoV-2 Test Recalled Due to False Negative Results

    Meridian Bioscience is recalling 376 Revogene SARS-CoV-2 test kits because the FDA withdrew the Emergency Use Application after false negative results were reported.

    Product
    Revogene SARS-CoV-2 Catalog Number: 410700 IVD for real-time Reverse Transcription Polymerase Chain Reaction (rRT-PCR) qualitative test run on the Revogene¿ instrument for the detection of SARS-CoV-2 nucleic acid from nasopharyngeal swab (NPS) specimens from individuals susp
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1496-2021·2021-05-05

    Siemens Recalls Artis Angiography Systems Due to Belt Corrosion

    Siemens is recalling 3,320 Artis angiography systems in the US because belt corrosion may cause system failure or unintended C-Arm movement.

    Product
    Artis systems - Product Usage: an angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Model Numbers: System Material # AXIOM Artis FC 05904433; AXIOM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1468-2021·2021-04-28

    Trinity Sterile Recalls Midline Catheter Dressing Change Kits Due to Seal Defects

    Trinity Sterile, Inc. is recalling 2,970 Midline Catheter Dressing Change Kits with Statlock because evidence of foreign material in the seal caused improper sealing and compromised sterility.

    Product
    Midline Catheter Dressing Change Kit with Statlock - Product Usage: Intended to provide ongoing vascular catheter maintenance (e.g., dressing change, catheter flushing). Product Number: TRIO0000l
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1474-2021·2021-04-28

    Smiths Medical Recalls Medex High Pressure Adaptors and LogiCal Kits

    Smiths Medical ASD Inc. is recalling specific lots of Medex High Pressure Adaptors and LogiCal Kits due to insufficient or incomplete welds.

    Product
    Gang Cath Lab Set, Model Number M20858R1.for the administration of IV fluids. Stopcocks and manifolds are used to control the direction of IV fluid flow.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1444-2021·2021-04-28

    Biotronik Ilestro 7 VR-T Defibrillators Recalled for Battery Depletion Risk

    Biotronik is recalling 323 Ilestro 7 VR-T defibrillators due to a potential for premature battery depletion. The devices are distributed nationwide and worldwide.

    Product
    BIOTRONIK Ilestro 7 VR-T, DF-4, REF 383580, UDI: 04035479125363 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1459-2021·2021-04-28

    Biotronik Inventa 7 ICDs Recalled for Premature Battery Depletion

    Biotronik is recalling Inventa 7 ICDs and CRT-Ds due to a potential for premature battery depletion. The recall covers devices distributed nationwide and worldwide.

    Product
    BIOTRONIK INVENTRA 7, VR-T DX DF-1 ProMRI, REF 399436, UDI: 04035479136314 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1479-2021·2021-04-28

    Smiths Medical Recalls High Pressure Rotators Due to Incomplete Welds

    Smiths Medical ASD Inc. is recalling specific lots of Medex High Pressure Rotators because they may have insufficient or incomplete welds.

    Product
    HIGH PRESSURE ROTATOR (Component) a. WITH MALE LUER LOCK, Model Number MX496HP b. WITH FEMALE LUER LOCK, Model Number MX497HP. component of extravascular blood-pressure Transducer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1473-2021·2021-04-28

    Smiths Medical Recalls LogiCal Left Heart Kits Due to Weld Defects

    Smiths Medical ASD Inc. is recalling specific lots of LogiCal Left Heart Kits and related components due to insufficient or incomplete welds.

    Product
    LogiCal Left Heart Kit, Model Number M20553. for blood pressure monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1476-2021·2021-04-28

    Smiths Medical Recalls Manifold Rotators Due to Incomplete Welds

    Smiths Medical ASD Inc. is recalling specific lots of manifold rotators and related components because they may have insufficient or incomplete welds.

    Product
    Manifold rotator (Component): a. 250 2 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1232MR b. 250 3 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1233MR c. 550 2 GANG MANIFOLD ROTATOR, OPEN HANDLE, Model Number MX1322MR d. 550 3 GANG MANIFOLD ROTATOR, OFF HANDLE, Mod
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1467-2021·2021-04-28

    AngioDynamics Safe Sheath Ultralite Recalled for Potential Sterility Compromise

    AngioDynamics is recalling specific Safe Sheath Ultralite kits due to potential sterility compromise. The recall affects 337 units distributed nationwide.

    Product
    AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer Catalogue #: VI10 - Product Usage: For the introduction of various types of pacing leads and catheters.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1437-2021·2021-04-28

    Stryker Recalls Tritanium X TL Spinal Instruments Due to Failure Risk

    Stryker Spine is recalling 169 sets of Tritanium X TL instruments because non-conforming components could lead to device failure during surgery.

    Product
    Tritanium X TL Instruments - intervertebral fusion device with bone graft, lumbar. Catalogs:TL Inserter (580220100), TL Draw Rod (580220101), Tube Set/Syringe Adapter Assembly (680220100), Syringe Plunger (680220102).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1448-2021·2021-04-28

    BIOTRONIK Iforia 7 Defibrillators Recalled for Premature Battery Depletion

    BIOTRONIK is recalling 490 Iforia 7 implantable defibrillators due to a potential for premature battery depletion. The devices are distributed nationwide and worldwide.

    Product
    BIOTRONIK Iforia 7,DR-T, DF-1,REF 390064, UDI: 04035479126926 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1460-2021·2021-04-28

    Biotronik Inventa 7 Defibrillators Recalled for Premature Battery Depletion

    Biotronik Inc is recalling 285 Inventa 7 defibrillators due to a potential for premature battery depletion. The devices are distributed nationwide and worldwide.

    Product
    BIOTRONIK INVENTRA 7, VR-T DX DF-1, REF 399437, UDI: 04035479136321 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1481-2021·2021-04-28

    Smiths Medical Recalls Medex Pressure Injector Lines Due to Weld Defects

    Smiths Medical ASD Inc. is recalling specific lots of Medex pressure injector lines and related components due to insufficient or incomplete welds.

    Product
    Medex 10 IN Pressure Injector Line w/Rot (1200psi) NS. REF B1681R, component of extravascular blood-pressure Transducer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1445-2021·2021-04-28

    BIOTRONIK Ilestro 7 VR-T DX Defibrillators Recalled for Battery Depletion

    BIOTRONIK Inc is recalling 3,664 Ilestro 7 VR-T DX implantable defibrillators due to a potential for premature battery depletion.

    Product
    BIOTRONIK Ilestro 7 VR-T DX, DF-1, REF 383594, UDI: 04035479125509 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1410-2021·2021-04-21

    K2M Chesapeake Cervical Drill Guide Inserter Recalled for Interference Defect

    K2M, Inc. is recalling the Chesapeake Cervical-Ti 10mm Drill Guide Inserter due to an interference condition that may cause spinal cord injury or screw misalignment.

    Product
    Chesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw construct providing stability to the anterior column (cervical spine) Catalog number: 3608-90033
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1385-2021·2021-04-21

    Recall of Covidien Signia Stapler Reloads Due to Safety Interlock Failure

    FDA is recalling specific lots of Covidien Signia stapler reloads because a safety interlock may fail, allowing empty reloads to be fired.

    Product
    Covidien Signia Small Diameter Curved Tip Intelligent Reload 30 mm Vascular/Thin 8 mm - Short Item Code:SIGSDS30CTVT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1414-2021·2021-04-21

    Roche cobas Liat Analyzer Respiratory Virus Panel Recall

    Roche is recalling the cobas Liat Analyzer respiratory virus panel due to invalid or false positive results for SARS-CoV-2 and Influenza A/B.

    Product
    cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catalog Number: 07341920190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1384-2021·2021-04-21

    Recall of Covidien Signia Vascular Stapler Reloads Due to Safety Interlock Failure

    FDA recalls 11,391 units of Covidien Signia vascular stapler reloads because a safety interlock may fail, allowing empty reloads to fire and cause tissue injury.

    Product
    Covidien Signia Grey Small Diameter Curved Tip Intelligent Reload 30 mm Vascular 8 mm - Short Item Code: SIGSDS30CTV
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1383-2021·2021-04-21

    FDA Recalls Covidien Signia Stapler Reloads Due to Safety Interlock Failure

    FDA is recalling specific lots of Covidien Signia stapler reloads because a safety interlock may fail, allowing empty reloads to be fired and causing tissue injury.

    Product
    Covidien Signia Small Diameter Curved Tip Intelligent Reload 45 mm Vascular/Thin 8 mm - Long Item Code: SIGSDL45CTVT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1343-2021·2021-04-14

    Fenwal Recalls Amicus MNC Apheresis Kits Due to Centrifuge Pack Leaks

    Fenwal Inc is recalling specific lots of Amicus MNC Apheresis Kits because centrifuge packs may leak blood during therapeutic procedures.

    Product
    Amicus MNC Apheresis Kit - Double Needle - Product Usage: intended for use in the collection of blood components and mononuclear cells.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1334-2021·2021-04-07

    CF Delivery Dev Caps Bravo x5 Recalled for Aspiration Risk

    FDA recalls CF Delivery Dev Caps Bravo x5 capsules because they may fail to attach to the esophagus, leading to aspiration.

    Product
    CF Delivery Dev Caps Bravo x5, FGS-0635/FGS 0636 - Product Usage: intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1313-2021·2021-04-07

    Medtronic Bio-Console 560 Blood Pumping Console Recalled for Electrical Failure

    Medtronic is recalling Bio-Console 560 devices because an electrical component may fail, causing the pump to stop and potentially producing smoke or a burning odor.

    Product
    Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console, Model Numbers: 560BC, 560BC1, 560BCS, 560BCS1, R560BCS1. Used in cardiopulmonary bypass (CPB) procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1335-2021·2021-04-07

    FDA Recalls Bravo pH Capsule Delivery Devices Due to Aspiration Risk

    The FDA is recalling Bravo pH Capsule Delivery Devices because the capsule may fail to attach to the esophagus, leading to aspiration and potential hospitalization.

    Product
    BRAVO PH CAPS DELIVERY DEV5-PK, FGS-0312/FGS-0313 - Product Usage: intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age.
    Category
    Medical Device
    Distribution
    Distributed nationwide