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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8076–8100 of 40056

  • SevereFDA (Devices)·Z-0930-2024·2024-02-14

    BrightView X Gamma Camera Detector May Fall, Causing Patient Injury

    Detectors in Philips BrightView X gamma cameras may fall unexpectedly due to component failure, risking patient injury including fractures and lacerations.

    Product
    BrightView X, gamma camera for SPECT; Model Nos.: 6-digit format 882478; 12-digit format 453560824741 453560829261;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0929-2024·2024-02-14

    BrightView Gamma Camera Detector May Fall and Injure Patients

    Philips BrightView gamma camera detectors may fall due to component failure, potentially causing patient injury including lacerations and fractures. The FDA is recalling all affected units.

    Product
    BrightView, gamma camera system; Model Nos.: 6-digit format 882480; 12-digit format 453560279781 453560279791 453560279811 453560279801; 4x4 digit format 2170-3000A 2170-3001A 2170-3002A 2170-3003A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0931-2024·2024-02-14

    Gamma Camera Detector May Fall Due to Component Failure

    The detector in Philips BrightView XCT gamma cameras may fall unexpectedly due to component failure. If it falls below the center of the gantry, it could cause abrasion, contusion, laceration, or fracture to patients' lower limbs.

    Product
    BrightView XCT, gamma camera for SPECT; Model Nos.: 6-digit format 882482; 12-digit format 453560462131 453560749161
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0842-2024·2024-02-14

    HeartMate Touch Communication System recalled for software pump operation defects

    Thoratec Corp. is recalling HeartMate Touch Communication Systems (1,560 units) due to software and controller defects causing unexpected LVAD pump starts or stops, potentially affecting patient safety.

    Product
    1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF HMT1100-R 3. HeartMate Touch Communication System, HMT1150 The HeartMate Touch Application is loaded onto a tablet and will provide a user interface with state-of-the-art
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0852-2024·2024-02-14

    Cardinal Health Monoject Sterile Syringes Recalled for Manufacturing Change

    Cardinal Health is recalling Monoject sterile syringes due to manufacturing changes. The recall affects Luer-Lock and Enteral syringe models distributed in the US and Canada.

    Product
    Cardinal Health Monoject, 3 mL Syringe Luer-Lock Tip Soft Pack, REF 1180300777
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1042-2024·2024-02-14

    Prestige Coil System Recalled for Risk of Foreign Emboli from Corroded Delivery Pusher

    BALT USA is recalling Prestige Coil Systems due to corrosion of the delivery pusher. Solder flux residue can cause the discolored hypotube to break off and enter patient blood vessels as foreign emboli.

    Product
    The Prestige Coil System is a product family of embolic coils with associated delivery system components. These devices are angiographically delivered through the vasculature to embolize peripheral vascular abnormalities. The devices are to be placed to create blood stasis, reduc
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-0977-2024·2024-02-14

    RotaFlow Centrifugal Pump Seal Defect Poses Infection Risk

    Maquet Medical Systems is recalling 1,090 RotaFlow centrifugal pumps used in heart surgery due to seal defects that could compromise sterile barriers and expose patients to infection.

    Product
    BEQ-RF-32-USA RotaFlow Centrifugal Pump with BIOLINE Coating, Product Code 701047554. For use with an extracorporeal cardiovascular or cardiopulmonary bypass circuit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1025-2024·2024-02-14

    Antibiotic susceptibility testing discs recalled for potential accuracy failures

    Becton Dickinson's BD BBL Sensi Disc Cefuroxime testing discs may have accuracy, reproducibility, or quality-control failures in antibiotic susceptibility testing. This could delay diagnosis and lead to inappropriate antibiotic selection.

    Product
    BD BBL Sensi Disc Cefuroxime- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231621¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0989-2024·2024-02-14

    Flow-i C40 Anesthesia System Recalled for Cybersecurity Vulnerability

    Getinge's Flow-i C40 Anesthesia System (model 6677400) contains a potential cybersecurity vulnerability allowing remote login attacks that could result in denial of service, system tampering, or remote code execution.

    Product
    Flow-i C40 Anesthesia System, model 6677400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0975-2024·2024-02-14

    Patient transportation system wheels may be attracted to MRI magnetic fields

    Ingenia Ambition X patient transportation system trolleys contain magnetic wheels that may be attracted to MRI magnetic fields, potentially causing trolley malfunction during patient procedures.

    Product
    Ingenia Ambition X (Product Number 781356) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1035-2024·2024-02-14

    BD BBL Moxifloxacin Test Discs Recalled for Susceptibility Testing Inaccuracy

    BD BBL Sensi Disc Moxifloxacin test discs are recalled due to possible failures in antibiotic susceptibility testing accuracy. Test failures could lead to delayed diagnosis or inappropriate antibiotic selection.

    Product
    BD BBL Sensi Disc Moxifloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231758¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1040-2024·2024-02-14

    BD Sensi Disc Tetracycline Recalls Due to Accuracy and QC Failures

    Becton Dickinson & Co. is recalling BD BBL Sensi Disc Tetracycline 30µg laboratory test kits due to potential accuracy and quality control failures in antibiotic susceptibility testing that could lead to delayed diagnosis or inappropriate antibiotic selection.

    Product
    BD BBL Sensi Disc Tetracycline 30 ug,used for semi-quantitative in vitro susceptibility testing. Catalog Number 230998 and 231344¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0992-2024·2024-02-14

    RX Series Copper Assay Requires Modified Testing Order

    Randox Laboratories issued a technical bulletin stating that RX Series Copper Assay tests must not be run directly after Total Protein tests, as this could produce falsely elevated copper results.

    Product
    RX Series Copper (Cu) Assay Ref. Number CU2340
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1055-2024·2024-02-14

    Philips Spectral CT 7500 software issue causes incorrect image labeling

    Philips Spectral CT 7500 imaging devices contain a software defect that can incorrectly label captured images, potentially causing misdiagnosis and incorrect treatment. Affected units total 33 in the US and 177 worldwide.

    Product
    Spectral CT 7500: Software Version 5.0, Model 728333 and Spectral CT 7500 China: Software Version 5.0, Model 728340.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1019-2024·2024-02-14

    BD BBL Sensi Disc Cefixime Antibiotic Susceptibility Test Accuracy Failures

    BD BBL Sensi Disc Cefixime testing discs are recalled due to potential accuracy and quality control failures that may result in delayed diagnosis or inappropriate antibiotic selection in clinical laboratories.

    Product
    BD BBL Sensi Disc Cefixime - 5 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231664¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1028-2024·2024-02-14

    BD BBL clarithromycin susceptibility test discs recalled for accuracy and quality failures

    Becton Dickinson recalls BD BBL Sensi Disc Clarithromycin-15 ug susceptibility testing discs due to accuracy and reproducibility failures that may produce inaccurate test results in clinical laboratories.

    Product
    BD BBL Sensi Disc Clarithromycin- 15 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231678¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1034-2024·2024-02-14

    Antibiotic Susceptibility Test Discs Recalled for Accuracy and QC Failures

    Becton Dickinson is recalling BD BBL Sensi Disc Minocycline test discs due to potential accuracy and quality control failures that may cause delayed test results, missed diagnoses, or inappropriate antibiotic selection.

    Product
    BD BBL Sensi Disc Minocycline - 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231250 and 231251¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0862-2024·2024-02-14

    Senographe Pristina X-ray system missing audible exposure termination signal

    GE Medical Systems is recalling 180 Senographe Pristina mammography X-ray systems because the audible signal indicating the end of X-ray exposure intermittently fails to sound, violating FDA safety requirements.

    Product
    Senographe Pristina
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1054-2024·2024-02-14

    Philips Spectral CT software issue causes image mislabeling

    A software defect in Philips Spectral CT on Rails affects image labeling, potentially leading to patient misdiagnosis and incorrect treatment. This FDA Class II recall affects one unit distributed across multiple U.S. states and internationally.

    Product
    Spectral CT on Rails: Software Version 5.1.0.X, model 728334.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1012-2024·2024-02-14

    BD antibiotic susceptibility testing discs recalled for accuracy failures

    Becton Dickinson is recalling BD BBL Sensi Disc Ampicillin antibiotic susceptibility testing discs due to accuracy and quality control failures that may cause delayed diagnosis or inappropriate antibiotic selection.

    Product
    BD BBL Sensi Disc Ampicillin - 10 ¿g, Catalog No. 230705 and 231264; 2 ¿g, Catalog No. 231263. Used for semi-quantitative in vitro susceptibility testing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1005-2024·2024-02-14

    Medical Device Recall: Guardian 4 Glucose Sensor Manufacturing Defect

    Medtronic is recalling Guardian 4 Glucose Sensors due to manufacturing defects in the glucose oxidase layer. Defects may cause sensors to malfunction or provide inaccurate readings, potentially affecting insulin dosing.

    Product
    Guardian 4 Glucose Sensor, REF: MMT-7040A, MMT-7040C1, MMT-7040C2, MMT-7040C3, MMT-7040D1, MMT-7040D2, MMT-7040MA, MMT-7040QC1, MMT-7040QC2, MMT-7040QC3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1008-2024·2024-02-14

    Brasseler dental burs recalled due to defective latching mechanism

    Brasseler USA recalls 440 dental burs due to right angle latch specification failure that prevents proper latching in dental handpieces.

    Product
    Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/package, Rx.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0973-2024·2024-02-14

    Ingenia 1.5T Patient Trolley Wheels May Attract to MRI Magnetic Field

    Philips is recalling Ingenia 1.5T patient transportation trolleys with magnetic wheels that could be attracted to MRI magnetic fields. These wheels pose a potential hazard in MRI-equipped facilities when the trolley operates near the magnetic field.

    Product
    Ingenia 1.5T (Product Number 781396) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1026-2024·2024-02-14

    Antibiotic Susceptibility Testing Disc Recall Due to Accuracy Concerns

    BD BBL Sensi Disc Chloramphenicol test discs may have accuracy and quality control failures during antibiotic susceptibility testing. This could cause delayed results or inappropriate antibiotic selections.

    Product
    BD BBL Sensi Disc Chloramphenicol- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 230733¿and 231274¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0981-2024·2024-02-14

    Insulin Assay Reagent Packs Recalled for Incorrect Unit Conversion

    Beckman Coulter is recalling 19,125 Access Ultrasensitive Insulin reagent packs due to an incorrect unit conversion factor in the assay protocol file. The error could produce inaccurate insulin test results.

    Product
    Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410
    Category
    Medical Device
    Distribution
    Distributed nationwide