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-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
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-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-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-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-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-0988-2024·2024-02-14
Anesthesia System Cybersecurity Vulnerability Poses Denial of Service Risk
The Flow-i C30 Anesthesia System contains a cybersecurity vulnerability allowing remote attackers to cause denial of service, tampering, or code execution, potentially creating hazardous conditions.
Product
Flow-i C30 Anesthesia System, model 6677300
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-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-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-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-0978-2024·2024-02-14
RotaFlow Centrifugal Pump sterile barrier defect FDA Class II recall
RotaFlow Centrifugal Pumps have potential seal defects that could compromise sterile barriers, risking infection in cardiac bypass patients. FDA recommends device identification and contact with manufacturer for remediation.
Product
BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating, Product Code 701047553. For use with an extracorporeal cardiovascular or cardiopulmonary bypass circuit.
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-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-0984-2024·2024-02-14
Dual Articulating Headrest May Fail to Lock During Surgery
Steris Corporation is recalling Dual Articulating Headrests that may fail to lock in position during patient procedures, potentially causing patient injury. Affected units were manufactured between August and October 2023.
Product
Dual Articulating Headrest, Velcro P/N P141210813, REF BF753
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0991-2024·2024-02-14
Flow-e Anesthesia System Model 6887900 Cybersecurity Vulnerability Recall
The Flow-e Anesthesia System model 6887900 is recalled due to a cybersecurity vulnerability that could allow remote access, denial of service, or code execution, potentially affecting anesthesia delivery safety.
Product
Flow-e Anesthesia System, model 6887900
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0862-2024·2024-02-14
Senographe Pristina X-ray system missing audible exposure termination signal
GE Medical Systems is recalling 180 Senographe Pristina mammography X-ray systems because the audible signal indicating the end of X-ray exposure intermittently fails to sound, violating FDA safety requirements.
Product
Senographe Pristina
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1016-2024·2024-02-14
BD antibiotic susceptibility test discs recalled for possible accuracy failures
BD BBL Sensi Disc Aztreonam test discs are recalled due to possible accuracy and quality control failures in antibiotic susceptibility testing. Failures could result in delayed diagnoses and inappropriate antibiotic selection.
Product
BD BBL Sensi Disc Aztreonam - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Numbers 231640¿and 231641.
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-1034-2024·2024-02-14
Antibiotic Susceptibility Test Discs Recalled for Accuracy and QC Failures
Becton Dickinson is recalling BD BBL Sensi Disc Minocycline test discs due to potential accuracy and quality control failures that may cause delayed test results, missed diagnoses, or inappropriate antibiotic selection.
Product
BD BBL Sensi Disc Minocycline - 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231250 and 231251¿
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-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-1009-2024·2024-02-14
Water Filter MAJ-2318 May Be Incorrectly Assembled, Risking Infection
Olympus MAJ-2318 water filters may be assembled incorrectly, allowing unfiltered tap water to contaminate reprocessed endoscopes and expose patients to infection risk.
Product
Water Filter MAJ-2318. This MAJ-2318 water filter has been designed to be used with Olympus endoscope reprocessor for prevent contamination of the rinse water. The MAJ-2318 water filter is compatible with OER-ELITE and OER-MINI.
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

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7251–7275 of 13652