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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14026–14050 of 27500

  • HighFDA (Devices)·Z-1478-2020·2020-03-25

    Aesculap Columbus Knee Implant Components Recalled for LDPE Particles

    Aesculap is recalling Columbus R/PS Tibia Plateau knee implant components because low-density polyethylene particles may be present on the surface upon opening.

    Product
    Columbus R/PS TIB.PLATEAU Cemented, various sizes, Knee implant components, model nos. NN058K NN070K NN071K NN072K NN073K NN074K NN075K NN076K NN077K NN078K NN079K Product Usage:Tibia-Plateaus are part of implants in the group of knee endoprosthetics. For these…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1518-2020·2020-03-25

    Avid Medical Recalls Custom Procedure Trays with Non-Sterile Gowns

    Avid Medical is recalling 400 custom procedure trays because they contain surgical gowns that may not be sterile, posing a risk of surgical site infection.

    Product
    Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1509-2020·2020-03-25

    Stryker Strykeprobe Outer Sheath Replacement Recalled for Insulation Risk

    Stryker is recalling Strykeprobe Outer Sheath Replacements because a length mismatch could cause the probe to melt, compromising insulation and allowing electricity to flow to the patient.

    Product
    Stryker, REF: 0250070450, 5.0 mm x 45 cm, Strykeprobe, Outer Sheath Replacement, RX Only, Non-Sterile, CE, UDI: (01) 07613327051926 This products was distributed with the following sheath/probe: 0250070451-PKG, 5MM X 45CM StrykeProbe Electrosurgical Probe, Spatula-Tip…
    Category
    Medical Device
    Distribution
    0 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-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
  • HighFDA (Devices)·Z-1473-2020·2020-03-18

    Medicrea Iliac Screws Recalled Due to Incorrect Component Orientation

    Medicrea International is recalling 3,529 Iliac Screws because an internal component was assembled incorrectly, which may cause the tulip head to disengage from the shank.

    Product
    Iliac Screws, multiple sizes, Article Nos. B36020500 B36020570 B36020580 B36020590 B36027500 B36027570 B36027580 B36027590 B36028500 B36028570 B36028580 B36028590 B36029500 B36029570 B36029580 B36029590 Screws manufactured in titanium alloy Ti-6Al-4V LI…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1450-2020·2020-03-18

    Medtronic Simulus 850 Sizer Kits Recalled Due to Porcine Tissue Contact

    Medtronic is recalling six Simulus 850 Semi Rigid Ring/Band Accessory Kits because demonstration units may have contacted porcine tissue.

    Product
    Medtronic Simulus 850 Semi Rigid Ring/Band Accessory Kit Used to size a patient's mitral or tricuspid valve in cardiac procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (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
  • HighFDA (Devices)·Z-1457-2020·2020-03-18

    EHOB Recalls Econocare Plus Waffle Overlay Due to Blood Contamination

    EHOB, Inc. is recalling specific lots of Econocare Plus Waffle Overlays due to potential contamination with human blood. No instances of contamination have been confirmed in distributed products.

    Product
    Econocare Plus Overlay Item: 1025EC. Intended to aid in the prevention and treatment of pressure injuries and general comfort - Product Usage: The EHOB WAFFLE Overlay intended use is as first line of defense for pressure injury prevention. The design provides the caregiver a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1472-2020·2020-03-18

    Medicrea Recalls Pedicle Screws Due to Incorrect Component Orientation

    Medicrea International is recalling 3,529 pedicle screws because an internal component was assembled incorrectly, which may cause the tulip head to disengage from the screw shank.

    Product
    Pedicle Screws, multiple sizes, Article Nos. B36004525 B36004530 B36004535 B36004540 B36004545 B36004550 B36004555 B36005530 B36005535 B36005540 B36005545 B36005550 B36005555 B36005560 B36006530 B36006535 B36006540 B36006545 B36006550 B36006555 B36006560…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1463-2020·2020-03-18

    RayStation Software Recall for Potential Treatment Planning Errors

    RaySearch Laboratories is recalling one RayStation 8A system in Tennessee due to a software defect that may cause incorrect treatment planning calculations.

    Product
    RayStation/RayPlan 8A Service Pack 1, Build Number 8.0.1.10, stand-alone software treatment planning system
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1452-2020·2020-03-18

    ARJOHUNTLEIGH Recalls Concerto and Basic Shower Trolleys Due to Safety Catch Failure

    ARJOHUNTLEIGH is recalling 669 Concerto and Basic Shower Trolleys because a mechanical failure in the safety catch could cause the side support to open, posing a risk of patient falls and injuries.

    Product
    Concerto & Basic Shower Trolly, Model Numbers BAB1000-01 (UDI: (01)05055982788083), BAB1000CON6102 [(01)05056097364483], BAB1007-01 [(01)05055982796255], BAB1101-01 [(01)05055982787949], BAB1102-01 [(01)05055982796156], BAB1103-01 [UDI: (01)05055982796163], BAB1107-01…
    Category
    Medical Device
    Distribution
    15 states