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

7976–8000 of 40007

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-0850-2024·2024-02-14
Cardinal Health Enteral Syringes Recalled for Pump Incompatibility
Cardinal Health Monoject enteral syringes (6, 12, 35, 60 mL) have compatibility issues with certain feeding pumps. The affected lots should not be used with enteral syringe feeding pumps.
Product
Cardinal Health Monoject, 60mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 460SE
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0847-2024·2024-02-14
Cardinal Health Monoject Enteral Syringes Recalled for Pump Incompatibility
Cardinal Health Monoject enteral syringes (6, 12, 35, 60 mL) in Lot 230503 and 230701 have compatibility issues with certain feeding pumps and should not be used.
Product
Cardinal Health Monoject, 6ML Enteral Syringe (purple) Low Dose (LDT) - For Use with ENFit Connection System, REF 406SE
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0856-2024·2024-02-14
Cardinal Health Monoject sterile syringes recalled due to manufacturing changes
Cardinal Health is recalling all sizes of its Monoject sterile syringes (Luer-Lock and ENFit models) nationwide due to manufacturing and rebranding changes. The FDA classified this as a Class I recall.
Product
Cardinal Health Monoject, 35 mL Syringe Luer-Lock Tip Soft Pack, REF 1183500777
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-0854-2024·2024-02-14
Cardinal Health Monoject Syringes Recalled Due to Manufacturing Changes
Cardinal Health is removing Monoject sterile syringes in multiple sizes due to manufacturing and rebranding changes. The recall affects products distributed nationwide in the US and Canada.
Product
Cardinal Health Monoject, 12 mL Syringe Luer-Lock Tip Soft Pack, REF 1181200777T
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0849-2024·2024-02-14
Cardinal Health Enteral Feeding Syringes Recalled for Pump Compatibility Issues
Cardinal Health Monoject enteral syringes in sizes 6mL to 60mL have compatibility issues with certain feeding pumps and may not properly connect. Cardinal Health recommends not using these syringes with enteral feeding pumps.
Product
Cardinal Health Monoject, 35mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 435SE
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0858-2024·2024-02-14
Cardinal Health Monoject Sterile Syringes Removed Due to Manufacturing Change
Cardinal Health 200, LLC is recalling all sizes of Monoject brand sterile syringes (both Luer-Lock and ENFit enteral types) due to manufacturing and rebranding changes. The recall expands previous correction actions to a complete product removal.
Product
Cardinal Health Monoject, 1 mL Purple Enteral Syringe with Enfit Connection Sterile, REF 401SE
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0851-2024·2024-02-14
Cardinal Health Monoject Syringes and Enteral Syringes Removed
Cardinal Health is removing all Monoject sterile syringes and enteral syringes due to manufacturing changes and rebranding efforts. These products are distributed across the U.S. and Canada.
Product
Cardinal Health Monoject, 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, REF 1180100777
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0990-2024·2024-02-14
Flow-c Anesthesia System cybersecurity vulnerability in 14 units
The Flow-c Anesthesia System model 6887700 has a cybersecurity vulnerability allowing potential denial of service, tampering, or remote code execution via remote login. Fourteen units were distributed in the United States.
Product
Flow-c Anesthesia System, model 6887700
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1031-2024·2024-02-14
BD BBL Sensi Disc Imipenem susceptibility test accuracy and quality failures
BD BBL Sensi Disc Imipenem susceptibility test discs may fail to accurately assess antibiotic resistance. This could delay diagnosis or lead to inappropriate antibiotic treatment selection.
Product
BD BBL Sensi Disc Imipenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231644 and 231645¿
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0993-2024·2024-02-14
FilmArray Pneumonia Panel Plus Test Kits Recalled for False Positive Results
BioFire Diagnostics is recalling FilmArray Pneumonia Panel Plus diagnostic test kits due to a potential for false positive results. These inaccurate results could lead to incorrect pneumonia diagnoses.
Product
FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (30 test kit)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1039-2024·2024-02-14
BD BBL Sensi Disc Antibiotic Test Discs Recalled for Accuracy Failures
Becton Dickinson is recalling BD BBL Sensi Disc antibiotic susceptibility test discs due to potential accuracy and quality control failures that may lead to incorrect antibiotic selection and delayed diagnosis.
Product
BD BBL Sensi Disc Sulfamethoxazole with Trimethoprim 23.75/1.25 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231536 and 231539¿
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1007-2024·2024-02-14
Globus Medical Cannula May Not Be Properly Sterilized
Some ExcelsiusGPS Cannulas have an internal gap that prevents proper sterilization, increasing infection risk. Globus Medical is recalling 570 units distributed worldwide.
Product
ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model No. 6143.2844
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1020-2024·2024-02-14
Cefotaxime antibiotic susceptibility test discs recalled for potential testing accuracy failures
BD BBL Sensi Disc Cefotaxime susceptibility testing discs may produce inaccurate results for H. influenzae, potentially leading to delayed diagnosis and inappropriate antibiotic selection. The FDA has recalled 2,363,168 units distributed domestically and internationally.
Product
BD BBL Sensi Disc Cefotaxime - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231606 and 231607¿; 5 ug, Catalog No. 291308¿
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-0979-2024·2024-02-14
Barco MDSC-8527 NXF Medical Display decoder functionality blocked
Barco is recalling MDSC-8527 NXF medical displays due to I2C cable defects in manufacturing that block the MNA decoder functionality. The recall affects a limited batch distributed in New Jersey.
Product
Barco MDSC-8527 NXF, Part Number K9352421
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-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-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
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-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-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-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-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

How to read this listing

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7976–8000 of 40007