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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17926–17950 of 40287

  • ModerateFDA (Devices)·Z-1484-2020·2020-03-25

    Materialise Recalls TRUMATCH Orthognathic Surgical Kit Due to Labeling Error

    Materialise N.V. is recalling TRUMATCH Orthognathic surgical kits because the package labeling indicates a different plate than the one actually included.

    Product
    TRUMATCH Orthognathic - Full Bimaxillary Surgical Kit, Catalog Number SD980.001
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1485-2020·2020-03-25

    Materialise Recalls TRUMATCH Orthognathics Genioplasty Surgical Kit Due to Labeling Error

    Materialise N.V. is recalling TRUMATCH Orthognathics Genioplasty Surgical Kits because the package labeling indicates a different plate than the one actually contained in the kit.

    Product
    TRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD980.013
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1510-2020·2020-03-25

    Arthrex Recalls Low Profile Screws Due to Incorrect Length

    Arthrex, Inc. is recalling 20 units of Low Profile Screws because they are 6 mm longer than intended. The defect may affect bone fixation.

    Product
    Low Profile Screw, 4.5 x 20 mm The Low Profile ScrewTM, 4.5 x 20 mm, AR-8545-20, is used with the Ankle Fusion Line of plates and is intended to provide internal unicortical or bicortical bone fixation.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1494-2020·2020-03-25

    Philips Allura Centron X-ray System Recalled for Capacitor Failure

    Philips is recalling 87 Allura Centron X-ray systems because a capacitor may fail after electrical surges, preventing image acquisition.

    Product
    Cardio Vascular-Allura Centron, system code 722400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1493-2020·2020-03-25

    Philips Allura CV20 X-ray System Recalled for Capacitor Failure

    Philips is recalling 128 Allura CV20 X-ray systems because a capacitor may fail after electrical surges, preventing image acquisition.

    Product
    Allura CV20, system code 722031
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1487-2020·2020-03-25

    Philips Integris Allura X-ray Systems Recalled for Capacitor Failure

    Philips is recalling 70 Integris Allura 15 & 12 X-ray systems because a capacitor may fail, preventing image acquisition.

    Product
    Integris Allura 15 & 12, monoplane (system code 722043) and biplane (system code 722044)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1507-2020·2020-03-25

    Smith & Nephew Recalls Legion PS Knee Inserts Due to Packaging Error

    Smith & Nephew is recalling 29 Legion PS High Flex XLPE Articular Inserts because they were packaged with an incorrect part.

    Product
    LEGION PS High Flex XLPE size 5-6 9mm Articular Insert
    Category
    Medical Device
    Distribution
    11 states
  • 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-1428-2020·2020-03-18

    Heartware Recalls HVAD System Battery Charger AC Adapters

    Heartware, Inc. is recalling 5,489 HVAD System Battery Charger AC Adapters because users might mistakenly insert them into the HVAD Controller power port.

    Product
    HeartWare HVAD System Battery Charger AC Adapter 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…
    Category
    Medical Device
    Distribution
    0 states
  • 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
  • HighFDA (Devices)·Z-1475-2020·2020-03-18

    Getinge 88-Series Washer Disinfectors Recalled for Chamber Leakage Risk

    Maquet Cardiovascular is recalling Getinge 88-Series washer disinfectors because ruptured spot welds may cause water leakage, posing slip and infection risks.

    Product
    Getinge 88-Series-washer disinfectors intended for cleaning, disinfection and drying Model Number: 88-5 Part Number: 88-103; 88-203
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1455-2020·2020-03-18

    Cardinal Health Recalls Non-Sterile Hypodermic Safety Needles

    Cardinal Health is recalling Monoject Hypodermic Safety Needles that were shipped as non-sterile but labeled as sterile. The firm is not aware of any patient harm.

    Product
    Monoject Hypodermic Safety Needle 25G x 5/8" Item Code 1182558 - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampules and parts of the body below the surface of the skin.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1453-2020·2020-03-18

    Cardinal Health Recalls Non-Sterile Monoject Syringes with Safety Needles

    Cardinal Health is recalling Monoject 3mL syringes with safety needles because they were shipped as non-sterile despite labeling. The firm is not aware of any patient harm reports.

    Product
    Monoject 3mL Syringe with Hypodermic Safety Needle, 22G x 1-1/2 . Item Code 11832215 - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampules and parts of the body below the surface of the skin.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1462-2020·2020-03-18

    RayStation 8A Software Recalled for Treatment Planning Calculation Errors

    RaySearch Laboratories is recalling RayStation/RayPlan 8A software due to a defect that causes incorrect treatment planning values when pitch or roll corrections are applied.

    Product
    RayStation/RayPlan 8A, Build Number 8.0.0.61, stand-alone software treatment planning system
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1468-2020·2020-03-18

    RayStation 9B Software Recalled for Pitch and Roll Correction Errors

    RaySearch Laboratories AB is recalling one RayStation/RayPlan 9B software system in Tennessee due to potential errors in position calculations during pitch or roll corrections.

    Product
    RayStation/RayPlan 9B, Build Number 9.1.0.933, stand-alone software treatment planning system
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1477-2020·2020-03-18

    Cordis Recalls POWERFLEX P3 Catheters Due to Potential Seal Voids

    Cordis is recalling one lot of POWERFLEX P3 PTA Dilation Catheters due to potential voids in the proximal seal area.

    Product
    Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1451-2020·2020-03-18

    BioFire FilmArray Gastrointestinal Panel Recalled for False Negative Results

    BioFire Diagnostics is recalling FilmArray Gastrointestinal Panel kits due to elevated false negative rates that may lead to incorrect treatment.

    Product
    FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (01)00815381020116, CE IVD, Rx Only
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1467-2020·2020-03-18

    RayStation 9A Software Recall for Pitch and Roll Correction Errors

    RaySearch Laboratories is recalling one RayStation/RayPlan 9A system in Tennessee due to potential errors in position propagation when pitch or roll corrections are applied.

    Product
    RayStation/RayPlan 9A, Build Number 9.0.0.113, stand-alone software treatment planning system
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1465-2020·2020-03-18

    RayStation 8B Software Recalled for Pitch and Roll Correction Errors

    RaySearch Laboratories is recalling one RayStation 8B treatment planning system in Tennessee due to a software error that may cause incorrect position values.

    Product
    RayStation/RayPlan 8B Service Pack 1, Build Number 8.1.1.8, stand-alone software treatment planning system
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1466-2020·2020-03-18

    RayStation 8B Software Recalled for Pitch and Roll Correction Errors

    RaySearch Laboratories is recalling one RayStation 8B software system in Tennessee due to a defect that causes incorrect position values when pitch or roll corrections are applied.

    Product
    RayStation/RayPlan 8B Service Pack 2, Build Number 8.1.2.5, stand-alone software treatment planning system
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1464-2020·2020-03-18

    RayStation 8B Software Recalled for Pitch and Roll Correction Errors

    RaySearch Laboratories AB is recalling one RayStation 8B software system in Tennessee due to potential errors in tabletop position propagation.

    Product
    RayStation/RayPlan 8B, Build Number 8.1.0.47, stand-alone software treatment planning system
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1458-2020·2020-03-18

    Nextremity Solutions Recalls Nextra Hammertoe Correction System Due to Driver Defect

    Nextremity Solutions is recalling 190 units of the Nextra Hammertoe Correction System because the driver may be oversized, making it difficult to remove from the implant.

    Product
    Nextra Hammertoe Correction System-4.5MM Middle, 3.2MM Proximal, SS, Sterile. REF: NX-4532K - Product Usage: The Nextra Hammertoe Correction System is a system of implants and associated instruments which is indicated for small bone reconstruction limited to inter-digital…
    Category
    Medical Device
    Distribution
    0 states