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.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

7251–7275 of 13652

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-1038-2024·2024-02-14
BD BBL Sensi Disc Rifampin Antibiotic Susceptibility Test Discs Recalled
BD BBL Sensi Disc Rifampin antibiotic susceptibility test discs are being recalled due to potential accuracy and quality control failures. These discs are distributed domestically nationwide and internationally.
Product
BD BBL Sensi Disc Rifampin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231541 and 231544¿
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1030-2024·2024-02-14
BD BBL Ertapenem Susceptibility Test Discs Recalled for Accuracy Failures
BD BBL Sensi Disc Ertapenem test discs are being recalled due to reproducibility and accuracy failures that may cause diagnostic errors, delayed diagnosis, or inappropriate antibiotic selection.
Product
BD BBL Sensi Disc Ertapenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 232174 and 232175¿
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1032-2024·2024-02-14
BD BBL Sensi Disc Levofloxacin Testing Discs Recalled for Accuracy Failures
Becton Dickinson is recalling 2,363,168 units of BD BBL Sensi Disc Levofloxacin testing discs (Catalog No. 231705, 231706) 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 Levofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231705 and 231706¿
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1010-2024·2024-02-14
PulseSpray Infusion System O-Ring Defect May Cause Medication Leaks
Angiodynamics is recalling PulseSpray Infusion System devices due to a manufacturing defect in the rotating adaptor O-ring that may compromise seal integrity and cause medication to leak during infusion.
Product
PulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20, UPN: H787125004045, REF: 12500404; Pulse Spray 3Fx135x20, UPN: H787125004155, REF: 12500415; and PULSE SPRAY 5F/45/10, UPN: H787125004235, REF: 12500423.
Category
Medical Device
Distribution
3 states
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
HighFDA (Devices)·Z-1022-2024·2024-02-14
BD BBL Sensi Disc Ceftaroline test discs recalled for accuracy failures
Becton Dickinson is recalling BD BBL Sensi Disc Ceftaroline test discs due to potential accuracy and quality control failures in antibiotic susceptibility testing. Incorrect test results may delay diagnosis and lead to inappropriate antibiotic selection.
Product
BD BBL Sensi Disc Ceftaroline - 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 232231¿
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0994-2024·2024-02-14
FilmArray Pneumonia Diagnostic Panel: Potential False Positive Results
BioFire Diagnostics is recalling the FilmArray Pneumonia Panel diagnostic test kit due to the potential for false positive results. The recall affects 274,290 units distributed worldwide.
Product
FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test kit)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1021-2024·2024-02-14
BD Sensi Disc Cefpodoxime Antibiotic Testing Discs Recalled for Accuracy Failures
Becton Dickinson is recalling BD BBL Sensi Disc Cefpodoxime testing discs due to potential accuracy failures in antibiotic susceptibility testing. The defect may cause inaccurate results, delayed diagnosis, or inappropriate antibiotic selection.
Product
BD BBL Sensi Disc Cefpodoxime - 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231673 and 231674¿
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1015-2024·2024-02-14
Antibiotic susceptibility test discs recalled for accuracy and quality failures
Becton Dickinson is recalling BD BBL Sensi Disc Azithromycin test discs due to potential accuracy and quality control failures that may delay diagnosis or result in inappropriate antibiotic selection.
Product
BD BBL Sensi Disc Azithromycin -15 ¿g, Catalog Number 231682¿used for semi-quantitative in vitro susceptibility testing.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1036-2024·2024-02-14
BD BBL Sensi Disc Ofloxacin discs recalled for antibiotic testing accuracy failures
Becton Dickinson is recalling BD BBL Sensi Disc Ofloxacin testing discs due to potential accuracy failures. These failures could lead to delayed diagnosis or inappropriate antibiotic selection.
Product
BD BBL Sensi Disc Ofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231672¿
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0997-2024·2024-02-14
Globus Medical Cranial Drill recalled for sterility breach risk
Globus Medical is recalling Cranial Drill 6.00mm units due to potential packaging breaches that may render the sterile product non-sterile, and discoloration near the drill tip.
Product
Globus Medical Cranial Drill, 6.00mm - instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref: 6143.1870S
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-0999-2024·2024-02-14
Surgical hip instruments recalled due to compromised sterility packaging
Howmedica Osteonics is recalling HRIS ACET CUP surgical instruments used in hip replacement surgery due to failed package seal integrity testing. The recall affects lot-numbered units distributed worldwide.
Product
HRIS ACET CUP CUT TIP 26X140 Part Number: 6210-5-100. single-use, sterile surgical instruments used during hip arthroplasty
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1041-2024·2024-02-14
Optima Coil Neurovascular Embolization Devices Risk Foreign Emboli From Corrosion
BALT's Optima Coil neurovascular embolization devices may have corroded solder flux residue on the delivery pusher that could break off and cause foreign emboli in patient blood vessels.
Product
Neurovascular embolization device. The Optima Coil System is a series specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other vascular anomalies. The system consists of an embolization coil implant com
Category
Medical Device
Distribution
27 states
HighFDA (Devices)·Z-1003-2024·2024-02-14
Siemens Atellica CH Immunoglobulin M Reagent Quality Control Bias
Siemens is recalling 7,075 units of its Total Immunoglobulin M diagnostic reagent due to potential negative bias in quality control and patient sample results. This could affect the accuracy of test results.
Product
Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
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-1006-2024·2024-02-14
Dental amalgam powder may not triturate properly, affecting restoration strength
Ivoclar Vivadent is recalling dental amalgam powder that may not triturate properly, affecting restoration strength and working characteristics. Dentists should stop using the recalled lot and contact the manufacturer.
Product
Article No. NA6050411, Valiant PhD No. 1 Econo
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1017-2024·2024-02-14
Medical Device Recall: BD BBL Cefaclor Antibiotic Susceptibility Test Disc
Becton Dickinson is recalling BD BBL Sensi Disc Cefaclor antibiotic susceptibility test discs due to possible accuracy and quality control failures. Affected discs may produce inaccurate results, risking delayed diagnosis or inappropriate antibiotic selection.
Product
BD BBL Sensi Disc Cefaclor - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231653¿
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0974-2024·2024-02-14
Patient Transportation System Recalled for Magnetic Wheel MRI Interference Risk
Philips is recalling Ingenia Elition X patient transportation systems due to magnetic wheels that may be attracted to MRI systems, posing a patient safety risk if used in MRI environments.
Product
Ingenia Elition X (Product Number 781358) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system
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-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-1033-2024·2024-02-14
BD BBL Sensi Disc Meropenem testing discs recalled for accuracy failures
Becton Dickinson is recalling BD BBL Sensi Disc Meropenem antibiotic susceptibility testing discs due to accuracy and quality control failures that may cause delayed or incorrect diagnostic results.
Product
BD BBL Sensi Disc Meropenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231703 and 231704¿
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0983-2024·2024-02-14
Steris Dual Articulating Headrest May Fail to Lock During Procedures
A Steris medical headrest may fail to lock during patient procedures, potentially causing injury or procedural delays. Affected units were manufactured between August and October 2023.
Product
Dual Articulating Headrest, Pad Ret P/N P141210805, REF BF754
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0982-2024·2024-02-14
Laboratory Analyzer Software Bug Could Produce Erroneous Clinical Test Results
Beckman Coulter DxI 9000 immunoassay analyzers may produce erroneous lab results due to software bugs affecting unit conversion and result calculation. Affected devices use software version 1.16 or earlier; 128 devices worldwide are impacted.
Product
DxI 9000 Access Immunoassay Analyzer running software version 1.16 or prior,
Category
Medical Device
Distribution
Distributed nationwide

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7251–7275 of 13652