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

7276–7300 of 13652

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-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-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-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-1014-2024·2024-02-14
BD Antibiotic Testing Discs Recalled for Accuracy Failures
Becton Dickinson recalled BD BBL Sensi Disc Augmentin testing discs due to potential accuracy and quality control failures in antibiotic susceptibility testing. Failures may lead to delayed diagnosis or inappropriate antibiotic selection.
Product
BD BBL Sensi Disc Augmentin - 3¿g, Catalog Number 291270¿used for semi-quantitative in vitro susceptibility testing.
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-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-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-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-1011-2024·2024-02-14
Lab testing discs recalled for potential antibiotic susceptibility testing failures
Becton Dickinson recalled 2.3 million lab testing discs used for antibiotic susceptibility testing due to potential quality control failures. These failures could lead to delayed diagnosis or inappropriate antibiotic selection.
Product
Sensi Disc Amoxicillin with Clavulanic Acid 20/10 ¿g, Catalog No. 231628 and 231629.¿ These discs are used for semi-quantitative in vitro susceptibility testing
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1024-2024·2024-02-14
BD BBL Sensi Disc Ceftriaxone Test Discs Recalled for Susceptibility Testing Accuracy Issues
BD BBL Sensi Disc Ceftriaxone susceptibility test discs may have accuracy and quality control failures. These defects could lead to delayed diagnosis or incorrect antibiotic selection for H. influenzae infections.
Product
BD BBL Sensi Disc Ceftriaxone- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231634 and 231635¿
Category
Medical Device
Distribution
Distributed nationwide
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-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-0986-2024·2024-02-14
Absorbable Surgical Tacks Recalled for Potential Sterility Compromise
Covidien LP is recalling AbsorbaTack Absorbable Fixation Device 30 due to packaging defects that may compromise product sterility. Fifty-four units were distributed in five states.
Product
AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm- -intended for fixation of prosthetic material to soft tissue in minimally invasive and open surgical hernia repair procedures Model ABSTACK30
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-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-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-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
27 states
HighFDA (Devices)·Z-1013-2024·2024-02-14
BD BBL Sensi Disc Ampicillin testing discs recalled for accuracy failures
Becton Dickinson is recalling 2.3 million antibiotic susceptibility testing discs due to accuracy and quality control failures. The discs may cause delayed or incorrect test results, potentially leading to inappropriate antibiotic selection.
Product
BD BBL Sensi Disc Ampicillin with Sulbactam 10/10 ¿g, Catalog Number 231660. 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-0976-2024·2024-02-14
Orthodontic Latex Elastics Mislabeled as Non-Latex by Manufacturer
FLEXSelect 5/16" Amber Latex Elastics were labeled as non-latex, creating allergy risk for latex-sensitive patients. Patients with latex allergies should immediately stop using the product.
Product
FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, tooth gap, Ref: AMD56
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0987-2024·2024-02-14
Flow-i C20 Anesthesia System cybersecurity vulnerability could enable remote attacks
The Flow-i C20 Anesthesia System has a cybersecurity vulnerability allowing potential remote access, denial of service attacks, or code execution. Healthcare facilities should contact the manufacturer for patches and guidance.
Product
Flow-i C20 Anesthesia System, model 6677200
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-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

How to read this listing

Filters

7276–7300 of 13652