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

6176–6200 of 27393

HighFDA (Devices)·Z-1018-2024·2024-02-14
BD Sensi Disc Cefepime antibiotic susceptibility testing accuracy failures
Becton Dickinson is recalling BD BBL Sensi Disc Cefepime antibiotic testing discs due to accuracy and reproducibility failures. These laboratory products may produce inaccurate test results, potentially leading to delayed diagnoses or inappropriate antibiotic treatment.
Product
BD BBL Sensi Disc Cefepime - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231696¿
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-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-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-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-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-1029-2024·2024-02-14
BD BBL Sensi Disc Doripenem antibiotic susceptibility testing accuracy failures
BD BBL Sensi Disc Doripenem susceptibility testing discs may fail to accurately test antibiotic resistance in H. influenzae, potentially leading to incorrect antibiotic selection and delayed diagnosis. The FDA has recalled 2,363,168 units.
Product
BD BBL Sensi Disc Doripenem- 15 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 232219¿
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0776-2024·2024-02-07
Medical Device Compressor Kits Recalled for Elevated Formaldehyde Levels
GE HealthCare is recalling EvAir compressor kits for CARESCAPE and Engström ventilators due to elevated formaldehyde levels found in preliminary testing. The recall affects 1,294 units distributed worldwide.
Product
EvAir CPRSR Kit Upgrade: a) DISS/CEE 7/7 230V 50/60 HZ, Model Number M1230849; b) DISS/NEMA 5-15 115V 60 HZ, Model Number M1230847; c) NIST/BS 1363 230V 50/60 HZ, Model Number M1230849; d) NIST/BS 546 230V 50/60 HZ, Model Number M1230849; e) NIST/CEE 7/7 230V 50/60 HZ,
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0863-2024·2024-02-07
Smiths Medical Medfusion Model 3500 Syringe Pump Software Defects
Smiths Medical recalls Medfusion Model 3500 syringe pumps (software versions before v6.0.0) due to multiple programming defects that could affect medication delivery rates, timing, and accuracy.
Product
smiths medical Medfusion Model 3500 Syringe pump
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0775-2024·2024-02-07
FDA recalls EVair 03 compressor models for elevated formaldehyde levels
FDA recalls EVair 03 air compressors (models 1609000, 1609002) for elevated formaldehyde when used with certain ventilators. The hazard was identified during preliminary testing under worst-case conditions: elevated room temperature (40°C) and minimal gas flow (2 L/min).
Product
EVair 03 (Jun-air) air compressor, model numbers: 1609000 and 1609002
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0939-2024·2024-02-07
EZDilate Wire Guided Balloon Recalled for Device Malfunction Issues
Olympus recalls EZDilate Wire Guided Balloon devices used for endoscopic dilation due to reported bursting, leaking, and retrieval failures affecting 1,639 units nationwide.
Product
EZDilate Wire Guided Balloon 6-7-8. indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years) Model: BD-410X-0855
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0944-2024·2024-02-07
Olympus EZDilate Balloon Device Recalled for Inflation and Deflation Issues
Olympus is recalling approximately 6,898 EZDilate Wire Guided Balloon devices due to reported bursting, leaking, and retrieval problems during medical procedures.
Product
EZDilate Wire Guided Balloon 18-19-20. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years). Model: BD-410X-2055
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0774-2024·2024-02-07
EVair Air Compressors Recalled for Elevated Formaldehyde Emissions
EVair air compressors (models M1230849, M1230847) made by Datex-Ohmeda are being recalled after testing detected elevated formaldehyde emissions. The compressors are used with CARESCAPE R860 and Engström ventilator systems.
Product
EVair air compressor, model numbers: M1230849 and M1230847
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0942-2024·2024-02-07
EZDilate Wire Guided Balloon Recalled for Device Malfunction and Patient Injury Risk
Olympus recalled 3,767 EZDilate Wire Guided Balloons due to reported inflation, deflation, and retrieval problems causing bursting, leaking, and foreign body lodgement in patients. The devices dilate strictures in the alimentary tract.
Product
EZDilate Wire Guided Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years). Model: BD-410X-1555
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0933-2024·2024-02-07
EZDilate esophageal balloons recalled for inflation failure and device leaking
Olympus is recalling EZDilate Fixed Wire Balloons for inflation and deflation failures. The devices may burst, leak, or leave foreign material in patients.
Product
EZDilate Fixed Wire Balloon 6-7-8. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-0880
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0864-2024·2024-02-07
Smiths Medical Medfusion 4000 Syringe Pump Software Defects Recall
The FDA is recalling Smiths Medical Medfusion Model 4000 syringe pumps due to software defects affecting medication delivery, alarms, and display accuracy. Users should install the latest software version to correct these issues.
Product
smiths medical Medfusion Model 4000 syringe pump
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0940-2024·2024-02-07
Olympus EZDilate Endoscopic Dilation Balloons Recalled for Device Failures
Olympus is recalling 2,991 EZDilate endoscopic balloons for problems with inflation and deflation. Reports include device bursting and leaking, and retained foreign bodies in patients during procedures.
Product
EZDilate Wire Guided Balloon 8.5-9.5-10.5. indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years) Model: BD-410X-1055
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0941-2024·2024-02-07
Endoscopic Dilation Balloons Recalled for Bursting and Leaking Failures
Olympus recalled 3,354 EZDilate wire-guided dilation balloons due to failures in inflation, deflation, and retrieval, with incidents of bursting, leaking, and foreign bodies left in patients.
Product
EZDilate Wire Guided Balloon 11-12-13. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years). Model: BD-410X-1355
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0924-2024·2024-02-07
Knee Replacement Insert May Degrade from Oxidized Raw Material
Howmedica Osteonics is recalling PS LIPPED TIBIAL INSERT ASSY DURACON knee replacement inserts manufactured with UHMWPE raw material over 5 years old. The aged material may develop elevated oxidation that could impact material properties.
Product
PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-413
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0872-2024·2024-02-07
Knee replacement implant recalled for material oxidation risk
Howmedica Osteonics is recalling SCORPIO RECESSED PATELLA knee replacement components due to potential oxidation of the UHMWPE material in units manufactured with raw material over 5 years of age.
Product
SCORPIO RECESSED PATELLA-Intended for knee repalcment Part Number: 3044-0032
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0889-2024·2024-02-07
Total Knee Replacement Component Recalled Due to Oxidation Risk
Howmedica Osteonics Corp. is recalling SCORPIO Total Knee replacement components from specific manufacturing batches due to potential oxidation in raw materials over 5 years old. Oxidation can impact the material's properties.
Product
SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #9 -Intended for knee replacement Part Number: 73-0910
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0936-2024·2024-02-07
EZDilate Endoscopic Balloon Devices Recalled for Malfunction and Foreign Body Risk
Olympus is recalling EZDilate Fixed Wire Balloon devices used for esophageal stricture treatment due to reports of inflation/deflation failures, bursting, leaking, and foreign body retention in patients.
Product
EZDilate Fixed Wire Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1580
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0937-2024·2024-02-07
EZDilate Fixed Wire Balloon Recalled for Device Failure and Foreign Body Risk
Olympus recalls approximately 5,031 EZDilate Fixed Wire Balloons due to device bursting, leaking, and foreign body incidents during esophageal dilation procedures. Patients should contact their healthcare provider if they received this device.
Product
EZDilate Fixed Wire Balloon 16-17-18. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1880
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0928-2024·2024-02-07
Tank hose assembly recalled for incorrect material and missing perforations
AtriCure recalls tank hose assemblies due to manufacturing defects. Certain lots have outer sheaths missing required pin perforations and inner tubes made of incorrect material.
Product
Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0833-2024·2024-02-07
Orthopedic surgical kits recalled for unassessed external component sterilization
American Contract Systems recalls 5,524 orthopedic surgical kits due to unassessed sterilization of external components that may lose functionality, drug efficacy, or have excess sterilization chemical residue.
Product
Custom procedural convenience kits and trays, Othopedic use, labeled as: a) HIP FRACTURE, kit number AHHF15C; b) HIP FRACTURE, kit number AHHF15D; c) Hand Pack, kit number BBHP10E; d) Lower Extremity, kit number BBLE40B; e) Custom Podiatry, kit number BOCP70J; f) ROB
Category
Medical Device
Distribution
Distributed nationwide

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6176–6200 of 27393