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

Category

All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

22726–22750 of 40339

  • ModerateFDA (Devices)·Z-2952-2018·2018-09-05

    Luminex Recalls Verigene Enteric Pathogens Test Cartridges Due to False Positives

    Luminex is recalling Verigene Enteric Pathogens Nucleic Acid Test Cartridges because they may produce elevated false positive results for Yersinia enterocolitica.

    Product
    Verigene Enteric Pathogens Nucleic Acid Test (EP) for detecting and identification of pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collected from individuals with signs and symptoms of…
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-2943-2018·2018-09-05

    Bard Midstream Urine Collector Recalled for Iodine Prep Pad Deficiency

    Bard Medical Division is recalling 131,950 urine collection kits because the included iodine prep pads failed to meet required assay levels for their expiration dating.

    Product
    Bard Midstream Urine Collector with Rigid Funnel and Iodophor Prep Pads. Product Packaging: Three (3) PVP-I prep pads are packed into each urine collection kit carton along with a pre-connected drainage funnel, specimen container, funnel lid, specimen lid and a room label.
    Category
    Medical Device
    Distribution
    24 states
  • ModerateFDA (Devices)·Z-2909-2018·2018-09-05

    Stryker QUIKFLAP Burr Hole Cover Recall Due to Packaging Compromise

    Stryker is recalling QUIKFLAP burr hole covers because the sterile packaging may become compromised after three years.

    Product
    QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01538S, for use on the cranium
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2913-2018·2018-09-05

    Stryker AXS PP Burr Hole Cover Recall for Packaging Compromise

    Stryker is recalling AXS PP burr hole covers because the sterile packaging may become compromised after three years.

    Product
    AXS PP, 1X14MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01544S, for use on the cranium
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2949-2018·2018-09-05

    DePuy P.F.C. SIGMA Revision Knee Distal Augment Recall

    DePuy Orthopaedics is recalling one P.F.C. SIGMA Revision Knee System Distal Augment because it may be missing the screw/collet assembly. The device was not distributed in the United States.

    Product
    P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2905-2018·2018-09-05

    Stryker QUIKFLAP Cranium Plates Recalled for Sterile Barrier Compromise

    Stryker Leibinger is recalling QUIKFLAP cranium plates because the sterile packaging may become compromised after three years, potentially affecting sterility.

    Product
    QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01531S, for use on the cranium
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2904-2018·2018-09-05

    Stryker QUIKFLAP Cranium Plates Recalled for Sterile Barrier Compromise

    Stryker is recalling QUIKFLAP cranium plates because the sterile packaging may become compromised after three years, potentially affecting sterility.

    Product
    QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01530S, for use on the cranium
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2901-2018·2018-09-05

    Stryker QUIKFLAP Burr Hole Cover Recall Due to Packaging Compromise

    Stryker is recalling QUIKFLAP burr hole covers because the sterile packaging may become compromised after three years.

    Product
    QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01524S, for use on the cranium
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2953-2018·2018-09-05

    Sysmex Fluorocell PLT Reagent Recalled for Inaccurate Platelet Counts

    Sysmex America is recalling Fluorocell PLT reagent because it may cause falsely low platelet and immature platelet fraction results.

    Product
    Sysmex XN-Series Fluorocell PLT, Catalog #CD994563. Distributed in the U.S.A. by Sysmex America, Inc., Lincolnshire, IL. Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets with the Sysmex XN-Series automated hematology…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2924-2018·2018-09-05

    Stryker Mako Vizadisc Knee Procedure Tracking Kit Recalled for Detection Issues

    Mako Surgical Corporation is recalling specific lots of the Stryker Mako Vizadisc Knee Procedure Tracking Kit because the reflective material may be damaged, preventing camera detection.

    Product
    Stryker Mako Vizadisc Knee Procedure Tracking Kit
    Category
    Medical Device
    Distribution
    35 states
  • ModerateFDA (Devices)·Z-2915-2018·2018-09-05

    Stryker AXS PP Burr Hole Cover Recall Due to Packaging Compromise

    Stryker is recalling AXS PP Burr Hole Covers because the sterile packaging may become compromised after three years, potentially affecting sterility.

    Product
    AXS PP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01548S, for use on the cranium
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2900-2018·2018-09-05

    Stryker QUIKFLAP Cranium Plates Recalled for Packaging Compromise

    Stryker is recalling QUIKFLAP cranium plates because the sterile packaging may become compromised after three years.

    Product
    QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01522S, for use on the cranium.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2945-2018·2018-09-05

    Ceterix Disposable Knot Pusher Recalled for High Cut Force

    Ceterix Orthopedics is recalling 96 units of the Disposable Knot Pusher / Suture Cutter because nonconforming blades may require higher than specified cut force.

    Product
    Ceterix Disposable Knot Pusher / Suture Cutter; NovoCut Suture Manager. Model# CTX-C001. orthopedic arthroscopic accessory.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2911-2018·2018-09-05

    Stryker AXS PP Cranium Plates Recalled for Packaging Compromise

    Stryker is recalling 22,831 AXS PP cranium plates because the sterile packaging may become compromised after three years.

    Product
    AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01541S, for use on the cranium
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2907-2018·2018-09-05

    Stryker QUIKFLAP Burr Hole Cover Recall Due to Packaging Compromise

    Stryker is recalling QUIKFLAP burr hole covers because the sterile packaging may become compromised after three years.

    Product
    QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01534S, for use on the cranium
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2899-2018·2018-09-05

    Stryker QuickFlap Sterile Procedure Packs Recalled for Packaging Compromise

    Stryker is recalling QuickFlap Sterile Procedure Packs because the sterile barrier may become compromised after three years.

    Product
    QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01521S The Stryker QuickFlap Sterile Procedure Pack is intended for reconstruction, stabilization and/or rigid fixation of non-load bearing bony areas subsequent to craniotomy, craniectomy…
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2902-2018·2018-09-05

    Stryker QUIKFLAP Burr Hole Cover Recall Due to Packaging Compromise

    Stryker is recalling QUIKFLAP burr hole covers because the sterile packaging may become compromised after three years, potentially affecting sterility.

    Product
    QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01526S, for use on the cranium
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2944-2018·2018-09-05

    Roche cobas p 612 Pre-Analytical System Recalled for Contamination Risk

    Roche is recalling 12 units of the cobas p 612 pre-analytical system because sample material may contact the pipetting nozzle, potentially causing false positive test results.

    Product
    Roche cobas p 612 pre-analytical system (63x) Model: 07563116001 The cobas p 612 pre-analytical system is a computer controlled fully automatic system for sorting of open and closed barcoded and centrifuged and non-centrifuged sample tubes. The cobas p 612 is intended for…
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-2914-2018·2018-09-05

    Stryker AXS PP Burr Hole Cover Recall Due to Packaging Compromise

    Stryker is recalling AXS PP burr hole covers because the sterile packaging may become compromised after three years, potentially affecting sterility.

    Product
    AXS PP, 1X20MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01546S, for use on the cranium
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2898-2018·2018-09-05

    Stryker QuickFlap Sterile Procedure Pack Recalled for Packaging Compromise

    Stryker is recalling QuickFlap Sterile Procedure Packs because the sterile barrier may become compromised after three years.

    Product
    QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01520S The Stryker QuickFlap Sterile Procedure Pack is intended for reconstruction, stabilization and/or rigid fixation of non-load bearing bony areas subsequent to craniotomy, craniectomy…
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2912-2018·2018-09-05

    Stryker AXS PP Cranium Plates Recalled for Packaging Compromise

    Stryker is recalling 22,831 AXS PP cranium plates because the sterile packaging may become compromised after three years.

    Product
    AXS PP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01541S, for use on the cranium
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Devices)·Z-2843-2018·2018-08-29

    Philips DigitalDiagnost 4.1 Footplate Hook Recall for Injury Risk

    Philips is recalling DigitalDiagnost 4.1 High Performance units because a defective hook allows the footplate to fall or swing, posing an injury risk to operators and patients.

    Product
    DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2895-2018·2018-08-29

    Philips SureSigns Patient Monitors Recalled for Battery Overheating and Ignition Risk

    Philips is recalling SureSigns VM, VS, and VSV patient monitors because lithium-ion batteries may overheat or ignite if not replaced on time, posing injury and property damage risks.

    Product
    Philips SureSigns VM 3/4/6/8 Patient Monitors, 863063 863064 863065 863066 863068 863077 863085 863086 863317 863287 863288 863289 The SureSigns VM4, VM6, and VM8 patient monitors are for use by health care professionals whenever there is a need for monitoring the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2848-2018·2018-08-29

    Philips DigitalDiagnost 2.x Upgrades Recalled Due to Footplate Safety Hazard

    Philips is recalling DigitalDiagnost 2.x Upgrades because a defective hook allows the footplate to fall or swing, posing a risk of injury to patients or operators.

    Product
    DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712081
    Category
    Medical Device
    Distribution
    Distributed nationwide