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

8001–8025 of 39844

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-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-1031-2024·2024-02-14
BD BBL Sensi Disc Imipenem susceptibility test accuracy and quality failures
BD BBL Sensi Disc Imipenem susceptibility test discs may fail to accurately assess antibiotic resistance. This could delay diagnosis or lead to inappropriate antibiotic treatment selection.
Product
BD BBL Sensi Disc Imipenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231644 and 231645¿
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-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-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-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-1054-2024·2024-02-14
Philips Spectral CT software issue causes image mislabeling
A software defect in Philips Spectral CT on Rails affects image labeling, potentially leading to patient misdiagnosis and incorrect treatment. This FDA Class II recall affects one unit distributed across multiple U.S. states and internationally.
Product
Spectral CT on Rails: Software Version 5.1.0.X, model 728334.
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-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-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-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-0990-2024·2024-02-14
Flow-c Anesthesia System cybersecurity vulnerability in 14 units
The Flow-c Anesthesia System model 6887700 has a cybersecurity vulnerability allowing potential denial of service, tampering, or remote code execution via remote login. Fourteen units were distributed in the United States.
Product
Flow-c Anesthesia System, model 6887700
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0997-2024·2024-02-14
Globus Medical Cranial Drill recalled for sterility breach risk
Globus Medical is recalling Cranial Drill 6.00mm units due to potential packaging breaches that may render the sterile product non-sterile, and discoloration near the drill tip.
Product
Globus Medical Cranial Drill, 6.00mm - instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref: 6143.1870S
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0983-2024·2024-02-14
Steris Dual Articulating Headrest May Fail to Lock During Procedures
A Steris medical headrest may fail to lock during patient procedures, potentially causing injury or procedural delays. Affected units were manufactured between August and October 2023.
Product
Dual Articulating Headrest, Pad Ret P/N P141210805, REF BF754
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-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
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
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-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-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-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

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8001–8025 of 39844