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

Agency

Category

Minimum severity

Clear filters

23551–23575 of 40299

  • 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-1614-2018·2018-06-13

    11-VI Incorporated Recalls Non-Certified Laser Diode Components for Firearms

    11-VI Incorporated is recalling 323,972 non-certified laser diode components used in firearm sights because they emit more than the 5 mW limit.

    Product
    11-VI Incorporated Laser diode component Non-certified laser diode component used in laser sights for firearms
    Category
    Consumer Product
    Distribution
    1 state
  • 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
  • ModerateFDA (Devices)·Z-2057-2018·2018-06-13

    Stryker Recalls Expired Arthroscopic Cannulas Due to Labeling Error

    Stryker is recalling 10 units of 8.0mm x 90mm Dri-Lok Threaded Cannulas because the expiration date was misprinted as August 2018 instead of August 2016.

    Product
    3910-090-800 ASSY, PKG, 8.0MM X 90MM DRI-LOK THREADED CANNULA, 5 units per box. The Disposable Cannula device is designed to be used as a port of entry for arthroscopic instruments into the joints.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2092-2018·2018-06-13

    Tosoh ST-AIA SHBG Assay Recalled Due to Strensiq Interference

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

    Product
    ST-AIA PACK SHBG; Part Number: 025238 Assay, Reproductive Hormone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2113-2018·2018-06-13

    Baxter SIGMA Spectrum Infusion Pump Instructions for Use Update

    Baxter Healthcare is updating the Instructions for Use for SIGMA Spectrum Infusion Pumps to correct a discrepancy regarding the height of secondary infusion hangers.

    Product
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), infusion pump, 35700BAX2 Product Usage: The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used for the controlled administration of fluids. These fluids may include…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2110-2018·2018-06-13

    Fresenius NaturaLyte Liquid Acid Concentrate Recalled for Mislabeled Part Numbers

    Fresenius Medical Care is recalling NaturaLyte Liquid Acid Concentrate bottles due to incorrect part number labeling.

    Product
    NaturaLyte¿ Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters, Part Number: 08-3231-1 Product Usage: This concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2067-2018·2018-06-13

    Tosoh Tumor Marker Assay Recalled Due to Strensiq Interference

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

    Product
    ST-AIA PACK PA; Part Number: 025263 Assay, Tumor Marker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2085-2018·2018-06-13

    Tosoh ST-AIA DHEA-S Assay Recalled Due to Strensiq Interference

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

    Product
    ST-AIA DHEA-S; Part Number: 025222 Assay, Reproductive Hormone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2083-2018·2018-06-13

    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: 025261 Assay, Reproductive Hormone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2062-2018·2018-06-13

    Siemens ADVIA Chemistry Urea Nitrogen Reagent Recalled for Calibration Failures

    Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Urea Nitrogen Reagent due to increased calibration failures that prevent the system from generating results.

    Product
    ADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) for use on ADVIA 1800, 2400 and XPT Chemistry Systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2053-2018·2018-06-13

    Siemens ADVIA Centaur BNP Assay Recalled for Potential Analyzer Malfunction

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur BNP assays because they may cause analyzer malfunction or reduced dilution recovery when used with specific diluents.

    Product
    ADVIA Centaur BNP (B-type Natriuretic Peptide), Catalog Numbers: 02816138 (100 tests), 02816634 (500 tests)
    Category
    Medical Device
    Distribution
    28 states
  • ModerateFDA (Devices)·Z-2054-2018·2018-06-13

    Siemens ADVIA Centaur TSH3-Ultra Assay Recalled for Analyzer Compatibility Issues

    Siemens is recalling specific lots of ADVIA Centaur TSH3-Ultra assays because they may cause reduced dilution recovery or inoperability when used with Multi-Diluent 15 on certain analyzers.

    Product
    ADVIA Centaur TSH3-Ultra (Thyroid Stimulating Hormone 3 Ultra), Catalog Numbers: 06491072 (100 tests), 06491080 (500 tests), 04862625 (2500 tests)
    Category
    Medical Device
    Distribution
    28 states
  • ModerateFDA (Devices)·Z-2059-2018·2018-06-13

    Randox RX Imola Analyzers Recalled for Software Termination Issue

    Randox Laboratories is recalling 41 RX Imola analyzers because a software defect may cause premature termination, delaying patient test results.

    Product
    RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry tests.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2107-2018·2018-06-13

    MicroAire SmartRelease Endoscopic System Recalled for Incorrect Sterilization Instructions

    MicroAire is recalling SmartRelease Endoscopic Systems because the Instructions for Use contain incorrect sterilization parameters.

    Product
    MicroAire SmartRelease Endoscopic System, Endoscopic Carpal Tunnel Release, SmartRelease Handpiece, containing IFU rev. D The MicroAire Carpal Tunnel Release System is for use in patients diagnosed with carpal tunnel syndrome that is not associated with, or secondary to, any…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2064-2018·2018-06-13

    Bardex Foley Catheter Recalled for Incorrect Retainer Cap Print

    C.R. Bard is recalling specific lots of Bardex Foley catheters because the retainer cap print is incorrect.

    Product
    Bardex Lubricath 3-Way 75cc Continuous Irrigation Foley Catheter (Creevy), 22Fr. Rx (01267522)
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2050-2018·2018-06-13

    NordicNeuroLab Recalls nordicBrainEx 2.0 Software Due to Image Orientation Errors

    NordicNeuroLab AS is recalling nordicBrainEx 2.0 software versions 2.1 and older because a DICOM header error may cause incorrect image orientation labeling.

    Product
    nordicBrainEx 2.0 provides analysis and visualization capabilities of dynamic MRI data of the brain, presenting the derived properties and parameters in a clinically useful context.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2112-2018·2018-06-13

    Baxter SIGMA Spectrum Infusion Pump Recall for Instructional Mismatch

    Baxter is recalling SIGMA Spectrum Infusion Pumps because the instructions for use specify a 20-inch bag drop, but the firm supplies 12.5-inch hangers.

    Product
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), infusion pump, 35700BAX and 35700ABB Product Usage: The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used for the controlled administration of fluids. These fluids may…
    Category
    Medical Device
    Distribution
    Distributed nationwide