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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14001–14025 of 27500

  • HighFDA (Devices)·Z-1521-2020·2020-03-25

    Avid Medical Recalls Custom Procedure Trays Due to Sterility Concerns

    Avid Medical, Inc. is recalling 628 custom procedure trays because they contain surgical gowns that may not be sterile. This poses a risk of surgical site infection and cross-contamination.

    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-1502-2020·2020-03-25

    Agfa DR 800 X-Ray System Recalled for Tomosynthesis Sequence Error

    Agfa N.V. is recalling two DR 800 X-ray systems because the tomosynthesis image acquisition sequence did not stop automatically after the expected number of exposures.

    Product
    AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a Tomographic X-ray system - Product Usage: TomoSynthesis is used to synthesize tomographic slices from a single tomographic sweep. The DR 800 is not intended for mammography applications
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1516-2020·2020-03-25

    Avid Medical Recalls Custom Procedure Trays Due to Sterility Concerns

    Avid Medical, Inc. is recalling 1,906 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-1524-2020·2020-03-25

    Medtronic CareLink 2090 Programmer Recalled for Cyber Vulnerabilities

    Medtronic is recalling 23,180 CareLink 2090 Programmer devices worldwide due to improper access control and cleartext transmission of sensitive information.

    Product
    Medtronic CareLink 2090 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices, such as pacemaker/ICD/CRT.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1498-2020·2020-03-25

    LivaNova Heater-Cooler System 3T Recalled for NTM Contamination Risk

    LivaNova is recalling Heater-Cooler System 3T units to reduce the risk of NTM contamination by providing validated cleaning and disinfection instructions.

    Product
    LivaNova Heater-Cooler System 3T - Product Usage: The Heater-Cooler 3T System is used to circulate water through heat exchangers to warm or cool a patient during cardiopulmonary bypass procedures lasting 6 hours or less.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1522-2020·2020-03-25

    Avid Medical Recalls Custom Procedure Trays Containing Non-Sterile Gowns

    Avid Medical is recalling 2,632 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-1497-2020·2020-03-25

    Siemens Artis Angiography Systems Recalled for Software Movement Blockage

    Siemens is recalling Artis angiography systems because a software issue could block stand and table movements.

    Product
    Artis zee Biplane, Model No. 10094141; Artis zee Ceiling, Model No. 10094137; Artis zee Floor, Model No. 10094135; Artis zeego, Model No. 10280959 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1517-2020·2020-03-25

    Avid Medical Recalls Custom Procedure Trays Due to Sterility Concerns

    Avid Medical, Inc. is recalling 1,644 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-1480-2020·2020-03-25

    Aesculap Recalls Columbus Knee Implant Components Due to LDPE Particles

    Aesculap Implant Systems LLC is recalling Columbus knee implant components because low-density polyethylene particles may be present on the surface when the packaging is opened.

    Product
    COLUMBUS CRA/PSA TIB.PLAT.CEMENTED, Knee implant components, various sizes, model nos. NN469K NN470K NN471K NN472K NN473K NN474K NN475K NN476K NN477K NN478K NN479K 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-1519-2020·2020-03-25

    Avid Medical Recalls Custom Procedure Trays Due to Sterility Concerns

    Avid Medical is recalling 230 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-1514-2020·2020-03-25

    Siemens IMMULITE 2000 Estradiol Test Kits Recalled for High Discordant Results

    Siemens Healthcare Diagnostics is recalling IMMULITE 2000 Estradiol test kits due to high discordant results that may lead to misinterpretation of patient menopausal status.

    Product
    IMMULITE 2000 Systems E2 Estradiol Catalog #: US: L2KE22(D) (200 tests) and L2KE26(D) (600 tests) and OUS: L2KE22 (200 tests), L2KE26 (600 tests) - Product Usage: For in vitro diagnostic use with the IMMULITE systems Analyzers for the quantitative measurement of estradiol in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1512-2020·2020-03-25

    Boston Scientific DYNAGEN EL ICD DR Recall for Unapproved Software

    Boston Scientific is recalling one DYNAGEN EL ICD DR device because a software update downloaded unapproved applications to four programmers.

    Product
    Boston Scientific, Implantable Cardioverter Defibrillator, DYNAGEN EL ICD DR, Model D152 - Product Usage: Implantable cardioverter defibrillators (ICDs) are intended to provide ventricular anti-tachycardia pacing (ATP) and ventricular defibrillation for automated treatment of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1495-2020·2020-03-25

    Siemens Artis Q Angiography Systems Recalled for Software Movement Issue

    Siemens is recalling Artis Q angiography systems because a software issue could block stand and table movements.

    Product
    Artis Q Biplane, Model No. 10848282; Artis Q Ceiling, Model No.10848281; Artis Q Floor, Model No. 10848280; Artis Q zeego, Model No. 10848283 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1523-2020·2020-03-25

    Avid Medical Recalls Custom Procedure Trays Due to Sterility Concerns

    Avid Medical is recalling 5,004 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-1501-2020·2020-03-25

    Siemens Ysio X-Ray System Recalled for Unexpected Tube Stand Movement

    Siemens is recalling Ysio X-Ray systems because a software error may cause the ceiling tube stand to move unexpectedly when activated by the user.

    Product
    Ysio, model no. 10281013 Product Usage: The product is a stationary X-Ray system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1503-2020·2020-03-25

    TeDan Surgical Recalls 3COR Distraction Screws Due to Packaging Damage

    TeDan Surgical Innovations LLC is recalling 3COR Distraction Screws because damaged packaging may have exposed the sterile products to non-sterile conditions, posing an infection risk.

    Product
    D-0012 3COR 12MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and the TSI Quick Start Distraction Screws products are intended for the distraction in the anterior approach to the cervical spine from C2 thru C7. The products are to be used by…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1515-2020·2020-03-25

    Avid Medical Recalls Custom Procedure Trays Due to Sterility Concerns

    Avid Medical is recalling 21,326 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-1481-2020·2020-03-25

    Aesculap Recalls Knee Implant Components Due to Potential LDPE Particles

    Aesculap Implant Systems LLC is recalling specific knee implant components because low-density polyethylene particles may be present on the surface upon opening.

    Product
    AS COLUMBUS CR/PS TIB.PLAT.CEMENTED,Knee implant components, various sizes, model nos. NN058Z NN070Z NN071Z NN072Z NN073Z NN074Z NN075Z NN076Z NN077Z NN078Z NN079Z NN470Z NN471Z NN472Z NN473Z NN474Z NN475Z NN476Z NN477Z NN478Z NN479Z Product Usage…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1482-2020·2020-03-25

    Aesculap Recalls Knee Implants Due to Potential LDPE Particles

    Aesculap Implant Systems LLC is recalling specific knee implant components because low density polyethylene particles may be present on the surface.

    Product
    COLUMBUS REV F TIBIA OFFSET CEMENTED, Knee implant components, various sizes, model nos. NR068K NR068Z NR070K NR070Z NR071K NR071Z NR072K NR072Z NR073K NR073Z NR074K NR074Z NR075K NR075Z NR076K NR076Z NR077K NR077Z NR078K NR078Z NR079K NR079Z Product…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1479-2020·2020-03-25

    Aesculap Recalls Columbus Knee Implant Components Due to LDPE Particles

    Aesculap Implant Systems LLC is recalling Columbus CR/PS Tibial Plateau knee implant components because low-density polyethylene particles may be present on the surface.

    Product
    COLUMBUS CR/PS TIB.PLAT.PLASMAPORE, Knee implant components, various sizes, model nos. NN081K NN082K NN083K NN084K NN085K NN086K NN087K NN088K NN089K Product Usage: Tibia-Plateaus are part of implants in the group of knee endoprosthetics. For these implant parts there…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1520-2020·2020-03-25

    Avid Medical Recalls Custom Procedure Trays Due to Sterility Concerns

    Avid Medical, Inc. is recalling 1,001 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-1504-2020·2020-03-25

    TeDan 3COR Distraction Screws Recalled for Potential Sterility Compromise

    TeDan Surgical Innovations is recalling 3COR Distraction Screws because damaged packaging may have exposed the sterile products to non-sterile conditions, posing an infection risk.

    Product
    D-0014 3COR 14MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and the TSI Quick Start Distraction Screws products are intended for the distraction in the anterior approach to the cervical spine from C2 thru C7. The products are to be used by…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1525-2020·2020-03-25

    Medtronic CareLink Encore Programmer Recalled for Cyber Vulnerabilities

    Medtronic is recalling CareLink Encore 29901 programmers due to improper access control and cleartext transmission of sensitive information.

    Product
    Medtronic CareLink Encore 29901 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices, such as pacemaker/ICD/CRT.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1513-2020·2020-03-25

    Siemens IMMULITE 1000 Estradiol Kits Recalled for Discordant Results

    Siemens Healthcare Diagnostics is recalling IMMULITE 1000 Estradiol kits due to high discordant results that may lead to misinterpretation of patient menopausal status.

    Product
    IMMULITE 1000 Systems E2 Estradiol Catalog #: US: LKE21(D) and OUS: LKE21 - Product Usage: For in vitro diagnostic use with the IMMULITE systems Analyzers for the quantitative measurement of estradiol in serum, as an aid in the diagnosis and treatment of various sexual…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1505-2020·2020-03-25

    TeDan Surgical Innovations Recalls Quick Start Distraction Screws Due to Sterility Concerns

    TeDan Surgical Innovations is recalling Quick Start Distraction Screws because damaged packaging may have exposed the sterile products to non-sterile conditions, posing a risk of infection.

    Product
    DS-0022 QUICK START DISTRACTION SCREW 12MM 5/BOX STERILE - Product Usage: These products are intended to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers.
    Category
    Medical Device
    Distribution
    0 states