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

7226–7250 of 13652

ModerateFDA (Devices)·Z-1086-2024·2024-02-21
Quidel Sofia 2 Flu + SARS Test Kits Recalled for Incorrect Expiration Dates
Quidel Corporation is recalling one lot of Sofia 2 Flu + SARS Antigen FIA diagnostic test kits due to incorrect expiration dates on packaging. Kits labeled to expire April 30 and May 31, 2025 actually expire September 12, 2024.
Product
The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a sandwich design that is used with Sofia 2 to detect nucleocapsid protein from influenza A, influenza B, and SARS-CoV-2. This test allows for the detection of SARS-CoV and SARS-CoV-2, but does not differ
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0855-2024·2024-02-14
Cardinal Health Monoject Syringe and Enteral Syringe Removal Due to Manufacturing Changes
Cardinal Health is removing Monoject sterile syringes (Luer-Lock and Enteral with ENFit) from the market due to manufacturing and rebranding changes. Distribution affected US and Canada.
Product
Cardinal Health Monoject, 20 mL Syringe Luer-Lock Tip Soft Pack, REF 1182000777
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0857-2024·2024-02-14
Cardinal Health Monoject Syringes Recalled Due to Manufacturing Changes
Cardinal Health is recalling all sizes of Monoject sterile syringes—including Luer-Lock and Enteral syringes with ENFit connections—due to manufacturing and rebranding changes. Products distributed across the U.S. and Canada.
Product
Cardinal Health Monoject, 60 mL Syringe Luer-Lock Tip Soft Pack, REF 1186000777T
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0853-2024·2024-02-14
Cardinal Health Monoject Syringes Recalled Due to Manufacturing Changes
Cardinal Health is removing all sizes of Monoject sterile syringes and enteral syringes from the market due to manufacturing and rebranding changes. Products were distributed in the US and Canada.
Product
Cardinal Health Monoject, 6 mL Syringe Luer-Lock Tip Soft Pack, REF 1180600777
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
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-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-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-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-0848-2024·2024-02-14
Enteral Syringes Recalled for Incompatibility with Feeding Pumps
Cardinal Health Monoject Enteral Syringes with ENFit connections are recalled due to compatibility issues with certain syringe feeding pumps. The manufacturer recommends they not be used with enteral syringe feeding pumps.
Product
Cardinal Health Monoject, 12mL Enteral Syringe (purple) For Use with ENFit Connection System, REF 412SE
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-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-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-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
SevereFDA (Devices)·Z-0859-2024·2024-02-14
Cardinal Health Monoject Syringes Removal Due to Manufacturing Changes
Cardinal Health is removing Monoject brand syringes due to manufacturing changes and rebranding efforts. The removal includes Luer-Lock and ENFit connection models distributed nationwide in the US and Canada.
Product
Cardinal Health Monoject, 3 mL Purple Enteral Syringe with Enfit Connection Sterile, REF 403SE
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-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
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-1037-2024·2024-02-14
BD BBL Sensi Disc Piperacillin/Tazobactam Antibiotic Testing Discs Recalled for Accuracy Issues
BD BBL Sensi Disc Piperacillin/Tazobactam antibiotic susceptibility testing discs are recalled due to potential quality control and accuracy failures. These failures may cause delayed or inaccurate test results, affecting patient diagnosis and antibiotic treatment selection.
Product
BD BBL Sensi Disc Piperacillin/Tazobactam- 100/10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231691 and 231692¿
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-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-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-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-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

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7226–7250 of 13652