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

Clear filters

22651–22675 of 40175

  • HighFDA (Devices)·Z-2942-2018·2018-09-05

    MedComp Recalls Duo Flow Double Lumen Catheters Due to Suture Wing Cracking

    Medical Components, Inc dba MedComp is recalling Duo Flow double lumen catheters because suture wings may crack or break, posing a risk of catheter dislocation, bleeding, and air emboli.

    Product
    DUO FLOW DOUBLE LUMEN CATHETER, XTP114CT, XTP114MT, ; RAULERSON DUO FLOW IJ DOUBLE LUMEN CATHETER/CATHETER SET, XTP114IJC, XTP114IJS, XTP114IJSE, XTP114MT-C, XTP116IJC, XTP116IJS, XTP116IJSE RAULERSON PRE-CURVED DUO-FLOW IJ DOUBLE LUMEN CATHETER W/SOFT TIP SET, W/MINI SCALPEL…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2910-2018·2018-09-05

    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 DRILLING SCREWS, Part Number 12-01540S, for use on the cranium
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2957-2018·2018-09-05

    Baxter Recalls FLOSEAL Special Applicator Tips Due to Plastic Formulation Error

    Baxter Healthcare is recalling FLOSEAL Special Applicator Tips because an incorrect plastic formulation was used in the blue luer component.

    Product
    FLOSEAL Special Applicator Tips in cartons labeled in part, "Floseal SPECIAL APPLICATOR TIPS***6 x Malleable Tip Trimmable Tip***Baxter***." The pouches inside the cartons are labeled in part, "Floseal SPECIAL APPLICATOR TIPS***Baxter***"."
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2923-2018·2018-09-05

    Tecan Recalls Cortisol Saliva Luminescence Immunoassay Kits for Inaccurate Results

    Tecan US, Inc. is recalling specific lots of the IBL International Cortisol Saliva Luminescence Immunoassay because the product generates cortisol values 1.3 to 1.8 times higher than the NIST standard.

    Product
    Cortisol Saliva Luminescence Immunoassay The IBL International Cortisol Saliva Luminescence immunoassay is intended for the in-vitro diagnostic quantitative determination of Cortisol in human saliva and for use as an aid in the diagnosis and treatment of adrenal disorders.…
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-2903-2018·2018-09-05

    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 12-01528S, for use on the cranium
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2908-2018·2018-09-05

    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, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01536S, for use on the cranium
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2948-2018·2018-09-05

    Medline Sodium Chloride Injection Recalled for Incorrect Overwrap Packaging

    Medline Industries is recalling 90,870 units of 0.9% Sodium Chloride Injection due to incorrect overwrap packaging. The product is intended for flushing IV catheters and tubing.

    Product
    Medline 0.9 % Sodium Chloride Injection, USP 5 mL in 10 mL Syringe ZR Intended for flushing IV catheters and IV tubing only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2906-2018·2018-09-05

    Stryker QUIKFLAP Cranial Plates Recalled for Sterile Barrier Compromise

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

    Product
    QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01532S, for use on the cranium
    Category
    Medical Device
    Distribution
    4 states
  • 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