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 27364

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-0975-2024·2024-02-14
Patient transportation system wheels may be attracted to MRI magnetic fields
Ingenia Ambition X patient transportation system trolleys contain magnetic wheels that may be attracted to MRI magnetic fields, potentially causing trolley malfunction during patient procedures.
Product
Ingenia Ambition X (Product Number 781356) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system
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-1038-2024·2024-02-14
BD BBL Sensi Disc Rifampin Antibiotic Susceptibility Test Discs Recalled
BD BBL Sensi Disc Rifampin antibiotic susceptibility test discs are being recalled due to potential accuracy and quality control failures. These discs are distributed domestically nationwide and internationally.
Product
BD BBL Sensi Disc Rifampin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231541 and 231544¿
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0981-2024·2024-02-14
Insulin Assay Reagent Packs Recalled for Incorrect Unit Conversion
Beckman Coulter is recalling 19,125 Access Ultrasensitive Insulin reagent packs due to an incorrect unit conversion factor in the assay protocol file. The error could produce inaccurate insulin test results.
Product
Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410
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-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-1040-2024·2024-02-14
BD Sensi Disc Tetracycline Recalls Due to Accuracy and QC Failures
Becton Dickinson & Co. is recalling BD BBL Sensi Disc Tetracycline 30µg laboratory test kits 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 Tetracycline 30 ug,used for semi-quantitative in vitro susceptibility testing. Catalog Number 230998 and 231344¿
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1027-2024·2024-02-14
BD antibiotic susceptibility test disc accuracy failures may affect H. influenzae diagnosis
Becton Dickinson is recalling antibiotic susceptibility test discs due to quality control failures that may produce inaccurate results. These failures could delay diagnosis and lead to inappropriate antibiotic selection for H. influenzae infections.
Product
BD BBL Sensi Disc Ciprofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231657¿and 231658¿
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-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-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
HighFDA (Devices)·Z-0985-2024·2024-02-14
Carter-Thomason CloseSure Surgical Kit Recall: Mislabeled Component Descriptions
CooperSurgical is recalling Carter-Thomason CloseSure System XL surgical kits due to incorrect component descriptions on packaging. The affected batch includes 127 boxes (381 total kits) with lot number 326728.
Product
Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of 3 Systems. Kit as labeled: Regard, Carter-Thomason CloseSure System, REF 733776, Contents: One (1) Carter-Thomason Suture Passer, One (1) 5 mm Pilot Guide, One (1) 10/12 mm Pilot Guide.
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-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-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-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
28 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-1012-2024·2024-02-14
BD antibiotic susceptibility testing discs recalled for accuracy failures
Becton Dickinson is recalling BD BBL Sensi Disc Ampicillin antibiotic susceptibility testing discs due to accuracy and quality control failures that may cause delayed diagnosis or inappropriate antibiotic selection.
Product
BD BBL Sensi Disc Ampicillin - 10 ¿g, Catalog No. 230705 and 231264; 2 ¿g, Catalog No. 231263. Used for semi-quantitative in vitro susceptibility testing.
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-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-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-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
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

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6176–6200 of 27364