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.

Filters

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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

13026–13050 of 27471

  • HighFDA (Devices)·Z-0042-2021·2020-10-07

    Riverpoint Medical Recalls Non-Sterile Velosorb Surgical Sutures

    Riverpoint Medical is recalling 3,109 units of Velosorb Fast Braided Absorbable Sutures because they are non-sterile. The defect could compromise the sterile field and increase the risk of surgical site infection.

    Product
    Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS-25 CV605, UDI: 20884521152295 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2941-2020·2020-09-30

    MicroPort Recalls PROFEMUR Titanium Hip Prosthesis Components Due to Fracture Reports

    MicroPort Orthopedics is recalling specific PROFEMUR Titanium hip prosthesis components due to reports of fractures after implantation.

    Product
    PROFEMUR Neck Long Titanium, Catalog Numbers: PHA01204, PHA01214, PHA01224, PHA01234, PHA01244, PHA01254, PHA01264. Hip prosthesis component.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-3005-2020·2020-09-30

    Siemens Syngo.via RT Image Suite Software Recall for Calibration Offset Error

    Siemens is recalling Syngo.via RT Image Suite software due to a calibration offset error that could result in incorrect radiation dose or dose applied to the wrong location.

    Product
    Software: Syngo.via RT Image Suite software version VA30_SP02 with license T_RT_IMAGE_SUITE_PAT_MARK Intended Use: used as an advanced application on a SOM10 scanner SMN: 10496180
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2985-2020·2020-09-30

    LivaNova Recalls Perceval Single Use Accessory Kits Due to Collapse Failure

    LivaNova is recalling 94 Perceval Single Use Accessory Kits because the Dual Collapser component may fail to reduce the heart valve diameter, preventing implantation.

    Product
    Perceval Single Use Accessory Kit, Size M, REF: ICV1346, Sterile EO, Rx Only, CE, UDI: 8022057015228 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3000-2020·2020-09-30

    ArthroCare Recalls SmartStitch Connectors Due to Manufacturing Error

    ArthroCare Corporation is voluntarily recalling 15,559 units of Smith&Nephew SmartStitch PerfectPasser Connectors because a manufacturing error may cause the upper jaw to detach during use.

    Product
    Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE 0123, UDI: 00817470006971
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-2984-2020·2020-09-30

    LivaNova Recalls Perceval Single Use Accessory Kits Due to Collapse Failure

    LivaNova is recalling 77 Perceval Single Use Accessory Kits because the Dual Collapser component may fail to reduce the heart valve diameter during implantation.

    Product
    Perceval Single Use Accessory Kit, Size S, REF: ICV1345, Sterile EO, Rx Only, CE, UDI: 8022057015204 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2989-2020·2020-09-30

    Wright Medical Recalls Evolve Stem Implants Due to Sterility Assurance Issues

    Wright Medical Technology is recalling 16 Evolve Stem 8.5mm implants because they lack sterility assurance. The recall covers units distributed in the US and several international countries.

    Product
    EVOLVE STEM 8.5MM Model # 496S085
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-3012-2020·2020-09-30

    Irvine Biomedical Recalls Steerable Diagnostic Catheters Due to Labeling Error

    Irvine Biomedical is recalling 40 units of Inquiry Steerable Diagnostic Catheters because packages were mislabeled with the wrong model and lot numbers, potentially causing procedure delays.

    Product
    Inquiry Steerable Diagnostic Catheter, REF: IBI-87002 - Product Usage: INDICATIONS FOR USE The Inquiry fixed curve and steerable electrophysiology catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies. The catheters are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3013-2020·2020-09-30

    Medline Recalls Central Line Dressing Change Trays Due to Seal Defects

    Medline Industries is recalling Central Line Dressing Change Trays because incomplete seals may compromise sterility. The recall affects kits distributed in Minnesota and Texas.

    Product
    Central Line Dressing Change Tray
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2986-2020·2020-09-30

    LivaNova Recalls Perceval Single Use Accessory Kits Due to Collapse Failure

    LivaNova is recalling 102 Perceval Single Use Accessory Kits because the Dual Collapser component may fail to reduce the heart valve diameter, preventing implantation.

    Product
    Perceval Single Use Accessory Kit, Size S, REF: ICV1349, Sterile EO, Rx Only, CE, UDI: 8022057015211 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2990-2020·2020-09-30

    Hologic Recalls Panther Fusion Tube Trays Due to Potential Leaks

    Hologic is recalling 607 Panther Fusion Tube Trays because they may leak, potentially invalidating patient results or causing false negatives in flu and RSV assays.

    Product
    Panther Fusion Tube Tray, Part: FAB-15004, REF: PRD-04000
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-2988-2020·2020-09-30

    LivaNova Recalls Perceval Dual Collapser Due to Valve Collapse Failure

    LivaNova is recalling specific lots of the Perceval Dual Collapser because complaints indicate the device may fail to collapse the heart valve during implantation.

    Product
    Perceval Dual Collapser, Size S/M, REF: ICV1235, Sterile EO, Rx Only, CE, UDI: 08022057014832 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allowing…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2987-2020·2020-09-30

    LivaNova Recalls Perceval Single Use Accessory Kits Due to Collapse Failure

    LivaNova is recalling specific lots of Perceval Single Use Accessory Kits because the Dual Collapser component may fail to reduce the heart valve diameter during implantation.

    Product
    Perceval Single Use Accessory Kit, Size M, REF: ICV1350, Sterile EO, Rx Only, CE, UDI: 8022057015259 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2995-2020·2020-09-30

    GE Healthcare Recalls NM 830 Medical Detectors Due to Loose Screws

    GE Healthcare is recalling 25 NM 830 detectors because rotor bearing screws were found loose. The devices are distributed in the US and internationally.

    Product
    NM 830 Model # H3910AC
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-2999-2020·2020-09-30

    ArthroCare Speed Stitch Needle Cassettes Recalled for Potential Breakage

    ArthroCare is recalling Speed Stitch Needle Cassettes because a supplier error may have resulted in needles made of titanium instead of stainless steel, posing a risk of breakage during use.

    Product
    Speed Stitch Needle Cassette
    Category
    Medical Device
    Distribution
    42 states
  • SevereFDA (Devices)·Z-2965-2020·2020-09-23

    Randox Ammonia Reagent Recall Due to Positive Bias in Patient Samples

    Randox Laboratories is recalling 143 kits of AM1015 Ammonia reagents due to a positive bias of up to 140 µmol/L observed in patient samples.

    Product
    AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-2975-2020·2020-09-23

    Inpeco Aptio Automation Systems Recalled for Potential Sample ID Mis-association

    Inpeco S.A. is recalling Aptio Automation systems with Sysmex Interface Modules because a firmware defect may mis-associate sample IDs, leading to incorrect or delayed clinical chemistry results.

    Product
    Aptio Automation systems with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to Rack Module FLX-295-10- Intended Clinical Chemistry Test Systems - Product Usage: The FlexLab 3.6 Automation is a modular system designed to automate…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2964-2020·2020-09-23

    Cook Zenith Alpha Abdominal Endovascular Graft Recalled for Excess Glue

    Cook Inc. is recalling Zenith Alpha Abdominal Endovascular Grafts due to excess glue in the delivery system handle, which may prevent full deployment.

    Product
    Zenith Alpha Abdominal Endovascular Graft - Distributed OUS only. Indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms Reference Part Number (RPN): ZIMB-22-108 ZIMB-22-118 ZIMB-22-128 ZIMB-22-70 ZIMB-22-84 ZIMB-22-98…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2970-2020·2020-09-23

    Siemens epoc BGEM Test Card Recalled for Inconsistent Glucose Results

    Siemens Healthcare Diagnostics Inc is recalling specific lots of epoc BGEM Test Cards due to sporadically inconsistent low glucose results that could delay diagnosis or cause unnecessary treatment.

    Product
    Siemens epoc BGEM Test Card-In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care SMN#/Model #: 10736382
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2953-2020·2020-09-23

    Integra LifeSciences Recalls 13 ft Handpiece Cables for Dermatome Sets

    Integra LifeSciences is recalling 74 units of 13 ft handpiece cables used in dermatome sets because the cables melt after sterilization.

    Product
    13 ft Handpiece Cable, component of the Dermatome Sets Model S and Model S6 and also as a spare part - Product Usage: are intended for use in the cutting of skin grafts for use in plastic surgery and/or burn treatment. These instruments are intended only for professional use in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2969-2020·2020-09-23

    Avanos MIC-KEY SF Gastrostomy Feeding Tube Recalled for Cracks

    Avanos Medical is recalling 284 units of MIC-KEY SF Gastrostomy Feeding Tubes because the devices had cracked or detached from the feeding tube body.

    Product
    AVANOS MIC-KEY SF Gastrostomy Feeding Tube
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2973-2020·2020-09-23

    Inpeco FlexLab Laboratory Automation System Recalled for Sample ID Errors

    Inpeco S.A. is recalling FlexLab laboratory automation systems because firmware issues may cause sample ID mis-association, leading to incorrect or delayed test results.

    Product
    FlexLab (FLX) with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to Rack Module FLX-295-10- Intended Laboratory Automation system - Product Usage: The FlexLab 3.6 Automation is a modular system designed to automate Pre-Analytical and…
    Category
    Medical Device
    Distribution
    Distributed nationwide