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 13652

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-1000-2024·2024-02-14
Hip Arthroplasty Surgical Instruments Recalled for Sterile Barrier Failure
Howmedica Osteonics Corp. is recalling hip arthroplasty surgical instruments after their sterile packaging failed integrity testing. Units with compromised packaging were distributed worldwide.
Product
HRIS ACET CUP CUT TIP 32X140 Part Number: 6210-5-200rker. single-use, sterile surgical instruments used during hip arthroplasty
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-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-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-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-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-0996-2024·2024-02-14
Globus Medical Cranial Drill recalled for potential sterility compromise
Globus Medical is recalling Cranial Drills due to potential sterility loss from packaging breaches and discoloration at the drill tip. The drills are used in cranial surgery with the ExcelsiusGPS system.
Product
Globus Medical Cranial Drill with Stop, 3.20mm - instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref: 6143.1842S
Category
Medical Device
Distribution
Distributed nationwide
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-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-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
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-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-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-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-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-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-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-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-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
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-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

How to read this listing

Filters

7301–7325 of 13652