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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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

23451–23475 of 40175

  • HighFDA (Devices)·Z-2120-2018·2018-06-13

    Orthofix Locking Screws Recalled for Failure to Engage Plates

    Orthofix, Inc. is voluntarily recalling locking screws from the Rival Reduce Fracture Plating System and Rival View Plating System because they were confirmed to not properly engage plates during surgery.

    Product
    Locking Screw, D 2.0MM X 8MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label. Size (Part Number): a) D 2.0MM X 8MM (002-E-20008); b) D 2.0MM X 10MM (002-E-20010); c) D 2.0MM X 12MM (002-E-20012); d) D 2.0MM X 14MM (002-E-20014); e) D 2.0MM X 16MM (002-E-20016); f) D…
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2069-2018·2018-06-13

    Tosoh ST-AIA CA 19-9 Assay Recalled Due to Drug Interference

    Tosoh Bioscience is recalling ST-AIA PACK CA 19-9 assays because the drug Strensiq interferes with the test, potentially causing inaccurate results.

    Product
    ST-AIA PACK CA 19-9; Part Number: 025271 Assay, Tumor Marker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2095-2018·2018-06-13

    Tosoh ST-AIA PACK HGH Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK HGH assays because Asfotase Alfa (Strensiq) interferes with the tests, potentially causing inaccurate results.

    Product
    ST-AIA PACK HGH; Part Number: 025266 Assay, Metabolic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2090-2018·2018-06-13

    Tosoh ST-AIA PACK LH II Recalled Due to Strensiq Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK LH II assays because Asfotase Alfa (Strensiq) interferes with the test, potentially causing inaccurate results.

    Product
    ST-AIA PACK LH II; Part Number: 025296 Assay, Reproductive Hormone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2093-2018·2018-06-13

    Tosoh ST-AIA PACK Testosterone Assay Recalled Due to Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK Testosterone assays because Asfotase Alfa interferes with the tests, potentially causing inaccurate results.

    Product
    ST-AIA PACK Testosterone; Part Number: 025204 Assay, Reproductive Hormone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2075-2018·2018-06-13

    Tosoh ST-AIA C-Peptide II Assay Recalled Due to Drug Interference

    Tosoh Bioscience is recalling ST-AIA PACK C-Peptide II assays because the drug Asfotase Alfa can cause inaccurate test results.

    Product
    ST-AIA PACK C-Peptide II; Part Number: 025283 Assay, Diabetes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2117-2018·2018-06-13

    Orthofix Rival View Kit Locking Screws Recalled for Failure to Engage Plates

    Orthofix, Inc. is voluntarily recalling Rival View Kit locking screws that failed to properly engage plates during surgery.

    Product
    Rival View Kit Locking and Non-Locking Screw D 2.7MM, D 3.2MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-009C
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2111-2018·2018-06-13

    CareFusion Recalls Alaris Extension Sets Due to Incorrect Tubing

    CareFusion 303, Inc. is recalling Alaris Extension Sets with microbore tubing because manufacturing errors resulted in incorrect priming volumes.

    Product
    Alaris Extension Sets with microbore tubing Model 20022 and 30914 Is used to administer fluid and medications from a syringe to the patient through a needle or catheter inserted into the patient's artery or vein. These model codes are extension sets that can be used with IV…
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2124-2018·2018-06-13

    Orthofix Locking Screws Recalled Due to Failure to Engage Plates

    Orthofix, Inc. is voluntarily recalling specific locking screws from the Rival Reduce Fracture Plating System and Rival View Plating System because they failed to properly engage plates during surgery.

    Product
    Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) D 3.2MM X 10MM (002-E-32010) b) D 3.2MM X 12MM (002-E-32012) c) D 3.2MM X 14MM (002-E-32014) d) D 3.2MM X 16MM (002-E-32016) e) D 3.2MM X 18MM (002-E-32018) f) D 3.2MM X 20MM…
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2123-2018·2018-06-13

    Orthofix Recalls Non-Locking Screws Due to Failure to Engage Plates

    Orthofix, Inc. is voluntarily recalling specific Non-Locking Screws because they failed to properly engage plates during surgery.

    Product
    Non-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a)D 3.2MM X 10MM (002-D-32010) b) D 3.2MM X 12MM (002-D-32012) c) D 3.2MM X 14MM (002-D-32014) d) D 3.2MM X 16MM (002-D-32016) e) D 3.2MM X 18MM (002-D-32018) f) D 3.2MM X 20MM…
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2073-2018·2018-06-13

    Tosoh ST-AIA PACK cTnI 2nd Gen Recalled Due to Drug Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK cTnI 2nd Gen assays because the drug Asfotase Alfa (Strensiq) interferes with the test, potentially causing inaccurate results.

    Product
    ST-AIA PACK cTnI 2nd Gen; Part Number: 025205 Assay, Cardiac Marker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2127-2018·2018-06-13

    Orthofix Rival Plating System Recalled Due to Screw Engagement Failure

    Orthofix is voluntarily recalling Rival Reduce Fracture Plating System and Rival View Plating System because locking screws failed to properly engage plates during surgery.

    Product
    Evans Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) 6MM Spacer (002-H-00006); b) 8MM Spacer (022-H-00008); c) 10MM Spacer (002-H-00010); d) 12MM Spacer (002-H-00012)
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2101-2018·2018-06-13

    GE Healthcare Recalls Centricity PACS-IW Medical Image Viewer

    GE Healthcare is recalling 44 units of the Centricity PACS-IW with Universal Viewer because image series may be missing without warning.

    Product
    Centricity PACS-IW with Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2087-2018·2018-06-13

    Tosoh Prolactin Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience is recalling ST-AIA PACK Prolactin assays because Asfotase Alfa (Strensiq) interferes with the tests, potentially causing inaccurate results.

    Product
    ST-AIA PACK Prolactin; Part Number: 025255 Assay, Reproductive Hormone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2128-2018·2018-06-13

    Orthofix Recalls Rival Plating Systems Due to Screw Engagement Failure

    Orthofix, Inc. is voluntarily recalling Rival Reduce Fracture Plating System and Rival View Plating System components because locking screws failed to properly engage plates during surgery.

    Product
    H-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) 12MM Spacer (003-H-12001); b) 15MM Spacer (003-H-15001); 20MM Spacer (003-H-20001); 25MM Spacer (003-H-25001); 30 MM (003-H-30001)
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2099-2018·2018-06-13

    Tosoh ST-AIA PACK Cystatin C Assay Recalled Due to Drug Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK Cystatin C assays because Asfotase Alfa (Strensiq) interferes with the test, potentially causing inaccurate results.

    Product
    ST-AIA PACK Cystatin C; Part Number: 025217 Assay, Kidney Marker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2094-2018·2018-06-13

    Tosoh ST-AIA PACK Cort Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK Cort assays because the drug Strensiq interferes with the tests, potentially causing inaccurate results.

    Product
    ST-AIA PACK Cort; Part Number: 025287 Assay, Metabolic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2103-2018·2018-06-13

    NordicNeuroLab fMRI AudioSystem Recalled for Acoustic Distortion and Heat

    NordicNeuroLab AS is recalling 64 fMRI AudioSystem units after a patient reported acoustic distortion and heat from headphones during a scan.

    Product
    fMRI Hardware System - AudioSystem, Version 1.0 The AudioSystem allows auditory signals from the stimulus presentation PC to enter the scanner room and to be presented to the patient. A communication console allows the operator to adjust the sounds from the PC and to speak to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2084-2018·2018-06-13

    Tosoh ST-AIA PACK HCG Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK HCG assays because Asfotase Alfa (Strensiq) interferes with the test, potentially causing inaccurate results.

    Product
    ST-AIA PACK HCG; Part Number: 025256 Assay, Reproductive Hormone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2082-2018·2018-06-13

    Tosoh Thyroid Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK TU thyroid assays because the drug Strensiq can cause inaccurate test results.

    Product
    ST-AIA PACK TU; Part Number: 025270 Assay, Thyroid
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2070-2018·2018-06-13

    Tosoh Tumor Marker Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience Inc. is recalling ST-AIA PACK 27.29 tumor marker assays because Asfotase Alfa (Strensiq) interferes with the tests, potentially causing inaccurate results.

    Product
    ST-AIA PACK 27.29; Part Number: 025202 Assay, Tumor Marker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2098-2018·2018-06-13

    Tosoh Tumor Marker Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK BMG tumor marker assays because Asfotase Alfa (Strensiq) interferes with the tests, potentially causing inaccurate results.

    Product
    ST-AIA PACK BMG; Part Number:025259 Assay, Tumor Marker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2129-2018·2018-06-13

    Orthofix Recalls Lapidus Plates Due to Screw Engagement Failure

    Orthofix is voluntarily recalling 156 Lapidus Plates because locking screws failed to properly engage the plates during surgery.

    Product
    Lapidus Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size/Step/Left or Right (Part Number): a) Small/0MM Step/Left (002-C-01000L); b) Small/0MM Step/Right (002-C-01000R); c) Large/0MM Step/Left (002-C-02000L); d) Large/0MM Step/Right (002-C-02000R); e)…
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2119-2018·2018-06-13

    Orthofix Non-Locking Screws Recalled Due to Failure to Engage Plates

    Orthofix, Inc. is voluntarily recalling specific non-locking screws from the Rival Reduce Fracture Plating System and Rival View Plating System because they failed to properly engage plates during surgery.

    Product
    Non-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label. Size (Part Number): a) D 2.0MM X 8MM (0002-D-20008); b) D 2.0MM X 10MM (002-D-20010); c) D 2.0MM X 12MM (002-D-20012); d) D 2.0MM X 14MM (002-D-20014); e) D 2.0MM X 16MM (002-D-20016); f) D 2.0MM X 18MM…
    Category
    Medical Device
    Distribution
    19 states