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 deaths or serious injuries are reported, 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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7326–7350 of 13652

  • HighFDA (Devices)·Z-0946-2024·2024-02-07

    Achieva 1.5T MRI Coil Seal Adhesive May Fail Creating Sharp Edges

    Philips Achieva 1.5T MRI scanner components may experience coil seal adhesive failure, creating sharp edges that could injure patients. Affected devices have been distributed worldwide.

    Product
    Achieva 1.5T Conversion. Model (REF) Numbers 781346, 781283.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0829-2024·2024-02-07

    Obstetrical Labor and Delivery Kits Recalled for Potential Functionality Loss

    American Contract Systems has recalled Labor and Delivery Packs because certain components may have lost functionality or efficacy due to unvalidated sterilization exposure.

    Product
    Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LABOR & DELIVERY PACK, kit number HILD52F; b) LABOR & DELIVERY PACK, kit number HILD52G
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0963-2024·2024-02-07

    Medline Adult Blood Culture Kits Recalled Due to Unlabeled Component Expiration Dates

    Medline is recalling specific Adult Blood Culture Kits because the expiration date of an internal Bactec component is not reflected on the kit insert, creating a risk of using an expired component.

    Product
    MEDLINE ADULT BLOOD CULTURE KIT, Reorder Number DYNDH1694A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0884-2024·2024-02-07

    Knee replacement bearing insert recalled due to material degradation risk

    Howmedica Osteonics Corp. is recalling Scorpio-Flex knee bearing inserts made with material over 5 years old that may develop oxidation affecting performance. Affected patients should contact their physician if they experience knee problems.

    Product
    Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0908
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0903-2024·2024-02-07

    Howmedica Osteonics Trident Knee Insert Recalled for Oxidation Risk

    Howmedica Osteonics Trident knee replacement inserts manufactured with raw material over 5 years old may have elevated oxidation levels affecting material properties. This FDA Class II recall applies to Lot Number 29518001.

    Product
    HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part Number: 620-00-32J
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0923-2024·2024-02-07

    Knee Replacement Component Recalled for Potential Material Oxidation

    Howmedica Osteonics is recalling PS Lipped Tibial Insert Assy knee replacement components manufactured with UHMWPE material older than 5 years due to potential oxidation affecting performance.

    Product
    PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-411
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0882-2024·2024-02-07

    SCORPIO TS TIB INSERT Knee Replacement Components Recalled for Potential Material Degradation

    Howmedica Osteonics is recalling SCORPIO TS TIB INSERT knee replacement inserts manufactured with aging raw material. The material may develop elevated oxidation that could affect performance.

    Product
    SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7524
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0876-2024·2024-02-07

    Knee Implant Inserts Recalled Due to Potential Material Degradation

    Howmedica Osteonics is recalling SCORPIO TS TIB knee implant inserts (Part Number 72-4-0510) manufactured with UHMWPE material over 5 years old. The material may have elevated oxidation levels that could affect implant performance.

    Product
    SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0510
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0947-2024·2024-02-07

    Philips Achieva 1.5T MRI system recalled for defective coil seal

    Philips is recalling the Achieva 1.5T Initial MRI system due to a defective Quadrature Body Coil seal. The adhesive may fail and create sharp edges that could cut or abrade patients during scanning.

    Product
    Achieva 1.5T Initial system. Model (REF) Numbers 781178.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0926-2024·2024-02-07

    Tibial Knee Replacement Implants Recalled Due to Material Oxidation

    Howmedica Osteonics is recalling tibial bearing inserts used in knee replacements manufactured from UHMWPE raw material over 5 years old. The material may develop elevated oxidation levels that could impact its structural properties.

    Product
    TIBIAL BEARING INSERT SERIES P-S I ASSY Intended for knee replacement Product Number: 7291-0324
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0902-2024·2024-02-07

    Knee Replacement Component Recalled for Potential Material Oxidation and Degradation

    Howmedica Osteonics is recalling TRIDENT 0 deg knee implant components manufactured with aged raw material that may have elevated oxidation levels, potentially affecting material properties.

    Product
    HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part Number: 620-00-32J
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0816-2024·2024-02-07

    Custom Anesthesia Kits Recalled Over Sterilization Validation Failure

    American Contract Systems recalls 182 anesthesia procedure kits due to improper sterilization assessment of added components. The kits may have compromised functionality, reduced drug efficacy, or elevated sterilant residue.

    Product
    Custom procedural convenience kits and trays, anesthesia, labeled as: a) HEART ANESTHESIA BUNDLE NS, Kit Number LMHA01V; b) OR/Anesthesia Central Line Insertion Kit, Kit Number UIAN43L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0922-2024·2024-02-07

    Knee replacement implant recalled for potential material oxidation risk

    Howmedica Osteonics is recalling the DUR PCA MTK REV INS RT knee replacement implant manufactured with UHMWPE material over 5 years old. The material can develop elevated oxidation levels that may degrade its properties.

    Product
    DUR PCA MTK REV INS RT Intended for knee replacement Product Number: 6728-2-711
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0846-2024·2024-02-07

    Cortera Spinal Fixation System screws recalled for incorrect dimensions

    XTANT Medical is recalling Cortera Spinal Fixation System screws that were manufactured with incorrect dimensions. Screws labeled 8.5 mm by 50 mm are actually 5.5 mm by 45 mm, potentially preventing proper screw engagement.

    Product
    Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0921-2024·2024-02-07

    Knee replacement implant recalled due to potential material degradation

    Howmedica Osteonics recalls DUR PCA MTK REV INS RT knee replacement implants due to potential oxidation of UHMWPE material that could compromise material properties. Patients should contact their healthcare provider.

    Product
    DUR PCA MTK REV INS RT Intended for knee replacement Product Number: 6728-2-709
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0860-2024·2024-02-07

    Philips Azurion 7 M20 FlexArm system recalled for software connectivity loss

    Philips Medical Systems recalls the Azurion 7 M20 FlexArm system due to a software issue causing loss of connectivity between the FlexArm and Maquet Magnus Table. The recall affects 28 systems worldwide.

    Product
    Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0894-2024·2024-02-07

    SCORPIO U-Dome Patella Knee Implant Recalled Due to Material Degradation Risk

    Howmedica Osteonics has recalled certain SCORPIO U-Dome Patella knee implants due to potential material oxidation in units manufactured with raw material over 5 years old. The oxidation may affect the implant's material properties.

    Product
    SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3308
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0874-2024·2024-02-07

    Knee replacement tibial insert recalled for potential material oxidation

    Howmedica Osteonics Corp. is recalling Series II tibial bear inserts used in knee replacements. Raw material over 5 years old may have elevated oxidation levels, potentially affecting material properties.

    Product
    SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052-0524
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0972-2024·2024-02-07

    NovoTHOR Whole Body Light Pod Gen 3.0 Canopy Strut Ball Stud May Fail

    A ball stud on the gas strut may fail on NovoTHOR Whole Body Light Pod units, potentially causing injury if the canopy malfunctions while someone is using the device.

    Product
    NovoTHOR Whole Body Light Pod, Gen 3.0 (1) Product Code S2188 - Reg (2) Product Code S2189 - Reg PRX (3) Product Code S2190 - XL
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0885-2024·2024-02-07

    Knee Replacement Insert Recalled Due to Potential Material Oxidation

    Howmedica Osteonics is recalling Scorpio-Flex knee prosthesis inserts due to potential oxidation in UHMWPE raw material over 5 years old, which could impact material properties.

    Product
    Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0910
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0928-2024·2024-02-07

    Tank hose assembly recalled for incorrect material and missing perforations

    AtriCure recalls tank hose assemblies due to manufacturing defects. Certain lots have outer sheaths missing required pin perforations and inner tubes made of incorrect material.

    Product
    Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0914-2024·2024-02-07

    Knee Replacement Inserts Recalled Due to Potential Material Degradation

    Howmedica Osteonics is recalling PRIMARY REV.TIB.INSERT-DURACON knee replacement inserts manufactured with aging UHMWPE material that has potential for oxidation affecting material properties. Affected lots: 36273601 and 36609701.

    Product
    PRIMARY REV.TIB.INSERT-DURACON Intended for knee replacement. Product Number: 6637-4-031
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0924-2024·2024-02-07

    Knee Replacement Insert May Degrade from Oxidized Raw Material

    Howmedica Osteonics is recalling PS LIPPED TIBIAL INSERT ASSY DURACON knee replacement inserts manufactured with UHMWPE raw material over 5 years old. The aged material may develop elevated oxidation that could impact material properties.

    Product
    PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-413
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0934-2024·2024-02-07

    Olympus EZDilate Balloons Recalled for Bursting, Leaking, and Retrieval Failure

    Olympus is recalling EZDilate Fixed Wire Balloons used for esophageal dilation due to reports of bursting, leaking, and difficulty retrieving the device. The recall affects 1,796 units distributed nationwide and internationally.

    Product
    EZDilate Fixed Wire Balloon 8.5-9.5-10.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1080
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0830-2024·2024-02-07

    Surgical kits for childbirth recalled for sterilization and functionality risks

    American Contract Systems is recalling C-section surgical kits that were sterilized without proper assessment. Components may have lost function or drug efficacy, or have excess sterilization residuals.

    Product
    Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) C-SECTION PACK, kit number FDCS01AA; b) C-SECTION PACK, kit number FDCS01AB; c) C-SECTION STERILE PACK, kit number HGCS68J; d) C-SECTION PACK, kit number HICS50H; e) C-SECTION
    Category
    Medical Device
    Distribution
    Distributed nationwide