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

7301–7325 of 13683

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-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-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-0995-2024·2024-02-14
Globus Medical Cranial Drills recalled for sterility loss and discoloration
Globus Medical is recalling Cranial Drills (2.40mm) due to packaging breaches that may compromise sterility and discoloration near the drill tip. Distributed worldwide.
Product
Globus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref : 6143.1834S
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1023-2024·2024-02-14
BD BBL Antibiotic Susceptibility Test Discs Recalled for Accuracy Failures
BD BBL Ceftazidime Sensi Discs used for antibiotic susceptibility testing may have accuracy failures affecting H. influenzae testing. This could lead to delayed diagnoses or inappropriate antibiotic selection.
Product
BD BBL Sensi Disc Ceftazidime- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231632¿and 231633¿
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1039-2024·2024-02-14
BD BBL Sensi Disc Antibiotic Test Discs Recalled for Accuracy Failures
Becton Dickinson is recalling BD BBL Sensi Disc antibiotic susceptibility test discs due to potential accuracy and quality control failures that may lead to incorrect antibiotic selection and delayed diagnosis.
Product
BD BBL Sensi Disc Sulfamethoxazole with Trimethoprim 23.75/1.25 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231536 and 231539¿
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-0979-2024·2024-02-14
Barco MDSC-8527 NXF Medical Display decoder functionality blocked
Barco is recalling MDSC-8527 NXF medical displays due to I2C cable defects in manufacturing that block the MNA decoder functionality. The recall affects a limited batch distributed in New Jersey.
Product
Barco MDSC-8527 NXF, Part Number K9352421
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-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-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-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-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
ModerateFDA (Devices)·Z-1053-2024·2024-02-14
Bubble Sensor for CARDIOHELP-i system has incorrect device identifier on label
Maquet Medical Systems is recalling the Bubble Sensor accessory for CARDIOHELP-i extracorporeal life support systems due to an incorrect UDI Device Identifier printed on the product label.
Product
Bubble Sensor (REF: 70105.5720)
Category
Medical Device
Distribution
13 states
ModerateFDA (Devices)·Z-0998-2024·2024-02-14
Sperm separation media kits recalled for incorrect component lot
Fujifilm is recalling sperm separation media kits because the lower layer component may not match the documented lot. The kits may contain an older component with a different shelf life, which could affect product performance.
Product
Sperm separation media are used to separate motile sperm from other constituents of semen.
Category
Medical Device
Distribution
22 states
ModerateFDA (Devices)·Z-1004-2024·2024-02-14
Olympus Paparella-Type Vent Tube Recall: Missing Expiration Date on Inner Packaging
Olympus Corporation of the Americas is recalling one lot of Paparella-Type Vent Tubes due to missing expiration date on the inner package, though the date is present on the outer packaging.
Product
Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate the middle ear subsequent to otitis media Model: 240044
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-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-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-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-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-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-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-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-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

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7301–7325 of 13683