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

25301–25325 of 26135

HighFDA (Food)·F-0780-2021·2021-07-21
Living Free Nerve & Muscle Herbal Dietary Supplement Soy Allergen Undeclared
Bea Lydeckers Naturals Inc is recalling Living Free Nerve & Muscle Herbal Dietary Supplement because the label declares lecithin but does not specify that it contains soy lecithin, potentially endangering consumers with soy allergies.
Product
Living Free Nerve & Muscle Herbal Dietary Supplement, 100 and 500 capsules per bottles. Product is packed in white, HDPE plastic bottles with threaded HDPE lids. Label is read in parts: "***Living Free Nerve & Muscle Herbal Dietary Supplement***Herbal and Glandular Suppleme
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2055-2021·2021-07-21
MRI Scanner Patient Orientation Button Confusion Affects Images
GE Healthcare's MRI scanners may have a button confusion issue where the Patient Orientation button is accidentally clicked instead of Save RX, potentially causing misoriented or incorrectly annotated images. 585 devices affected worldwide.
Product
Discovery MR750w 3.0T - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2050-2021·2021-07-21
EcoFit Cementless Acetabular Cup Plugs May Loosen During Hip Surgery
Central hole cover plugs on EcoFit cementless acetabular cups may come loose during surgical implantation, potentially extending operation time or requiring revision surgery. Fifty-one units in Florida and Texas are affected.
Product
EcoFit cup cementless: Model(Catalog Number)/Description: 02200046 /EcoFit cup cementless 46mm dia incl. central hole cover; 02200048 /EcoFit cup cementless 48mm dia incl. central hole cover; 02200050 /EcoFit cup cementless 50mm dia incl. central hole cover; 02200052 /EcoFit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2068-2021·2021-07-21
Arrow Pacing Catheter Kit Recalled for Missing FDA Premarket Clearance
Arrow International is recalling the Pacing Catheter Kit-Bipolar Electrode Catheter (48 units) due to marketing without required FDA premarket clearance (510K). Units were distributed nationwide in FL, ID, IL, NY, OH, and TX.
Product
Arrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 Fr. 110 cm, Product Code: AI-05210 - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2047-2021·2021-07-21
Canon Vantage Galan 3T MRI System Recalled for Fire Risk
Canon Medical System is recalling Canon Vantage Galan 3T MRI systems due to a component that does not meet flame retardancy standards, which could result in smoke or fire. The recall affects units distributed nationwide.
Product
Canon Vantage Galan 3T, REF: MRT-3020 - Product Usage: use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast e
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2057-2021·2021-07-21
GE Healthcare SIGNA PET/MR button mix-up causes image orientation errors
GE Healthcare is recalling 71 SIGNA PET/MR imaging devices worldwide. A software issue allows the Patient Orientation button to be accidentally clicked instead of Save RX, resulting in incorrectly annotated or flipped diagnostic images.
Product
SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2025-2021·2021-07-21
Shoulder prosthesis component distributed with incorrect thickness due to lot swap
Two lots of Aequalis Ascend Flex Shoulder System Reversed Tray components were swapped during distribution, resulting in packages containing components with incorrect thickness.
Product
Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile Manufacturer Tornier SAS - Saint Martin, France. Shoulder prosthesis component.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2065-2021·2021-07-21
GE SIGNA HDxt MRI System: Orientation Button Error Risk
GE Healthcare recalls 91 SIGNA HDxt MRI systems worldwide. The Patient Orientation button may be accidentally clicked instead of Save RX, potentially causing diagnostic images to be incorrectly oriented or flipped.
Product
1.5T SIGNA HDxt (HD28) MR System, Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2054-2021·2021-07-21
GE Healthcare SIGNA Pioneer MRI scanner control panel button design issue
GE Healthcare recalls 460 SIGNA Pioneer MRI scanners worldwide due to a control panel button design flaw. Patient Orientation button may be accidentally clicked instead of Save RX, potentially resulting in incorrect image annotation or orientation.
Product
SIGNA Pioneer - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2075-2021·2021-07-21
Medical device software c4D fails to change site upon synchronization
C-RAD POSITIONING AB is recalling Catalyst positioning software c4D because it fails to properly update the Site field during synchronization in the setup workflow. This software defect may prevent correct system configuration.
Product
PC Application Software c4D as part of the device Catalyst: SP-002 Software PA-003 version 6.1.1 and 6.1.0
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2045-2021·2021-07-21
Canon 1.5T MRI System Recalled for Flame Retardancy Component Failure
Canon Vantage Tiitan 1.5T MRI Systems with certain serial numbers are recalled due to a component lacking proper flame retardancy, which could result in smoke or fire.
Product
Canon Vantage Tiitan 1.5T, Premium Open-Bore MRI System, REF: MRT-1510 - Product Usage: use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this sy
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2071-2021·2021-07-21
Arrow Temporary Pacing Catheter Distributed Without FDA 510K Clearance
Arrow International is recalling its Temporary Pacing Catheter/Introducer Kit because it was marketed without required FDA 510K clearance. Approximately 15 units were distributed in multiple U.S. states.
Product
Arrow Temporary Pacing Catheter/Introducer Kit 5Fr. pacing catheter 6 Fr. introducer Product Code: AI-07155-IK - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.
Category
Medical Device
Distribution
Distributed nationwide
HighCPSC·21167·2021-07-21
Caldwell E-Max Pro BT Earmuffs Recalled for Fire and Burn Hazards
American Outdoor Brands is recalling Caldwell E-Max Pro BT Earmuffs with rechargeable lithium battery packs due to a soldering defect that can cause the unit to overheat, posing fire and burn hazards. No injuries have been reported.
Product
Caldwell E-Max® Pro BT Earmuffs with rechargeable lithium battery packs
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2076-2021·2021-07-21
Medtronic LINQ II Insertable Cardiac Monitor Detection Failure Recall
Medtronic is recalling the LINQ II Model LNQ22 Insertable Cardiac Monitor because it may fail to detect dangerous heart rhythms after a restart. The device was distributed worldwide.
Product
Medtronic LINQ II Model Number # LNQ22 Insertable Cardiac Monitor Sterile EO Rx Only
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·21V554000·2021-07-21
2021 BMW X2 Seat Belt Retractor Defect Increases Injury Risk
BMW is recalling certain 2021 X2 vehicles because the passenger seat belt retractor may deactivate early, failing to comply with federal safety standards. The defective retractor could increase injury risk in a crash.
Product
BMW — 2021 BMW X2
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2063-2021·2021-07-21
MRI System Patient Orientation Button Click Error May Flip Images
GE Healthcare is recalling 1,519 Optima MR450w MRI systems worldwide due to a button interface error. The 'Patient Orientation' button may be unintentionally clicked instead of 'Save RX,' causing incorrectly oriented or flipped diagnostic images.
Product
Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2077-2021·2021-07-21
Urethral bulking system needles recalled due to sterility assurance failure
Axonics is recalling BULKAMID urethral bulking system needles that may not have been adequately sterilized despite sterile labeling. Unsterilized surgical needles pose infection risk.
Product
BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid Needle, REF 230651221C, 2 G x 12 am, sterile, CE 0476
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2052-2021·2021-07-21
MRI scanner user interface defect may cause incorrectly oriented images
GE Healthcare recalls SIGNA Premier MRI scanners (100 devices, worldwide distribution) due to a user interface defect where the Patient Orientation button may be inadvertently clicked instead of Save RX, potentially resulting in incorrectly annotated or flipped diagnostic images.
Product
SIGNA Premier - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
Category
Medical Device
Distribution
0 states
HighFDA (Food)·F-0779-2021·2021-07-21
Living Free Lung & Joint Congestion Herbal Dietary Supplement Soy Allergen
Bea Lydeckers Naturals Inc is recalling Living Free Lung & Joint Congestion Herbal Dietary Supplement because the label declares lecithin but does not identify it as soy lecithin, creating an undeclared soy allergen hazard.
Product
Living Free Lung & Joint Congestion Herbal Dietary Supplement, 100 and 500 capsules per bottles. Product is packed in white, HDPE plastic bottles with threaded HDPE lids. Label is read in parts: "***Living Free Lung & Joint Congestion Herbal Dietary Supplement***Glandular,
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2072-2021·2021-07-21
HeartWare HVAD Pump Implant Kit Impeller Defect Recall
HeartWare HVAD Pump Implant Kit (REF MCS1705PU) recalled because the pump's impeller shroud height does not meet the lower control limit. The device is used for hemodynamic support in patients with advanced heart failure.
Product
HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in pat
Category
Medical Device
Distribution
0 states
HighNHTSA·21V545000·2021-07-20
2022 Tiffin Phaeton motorhomes recalled for fuel hose fire risk
Tiffin is recalling 2021-2022 Phaeton and Allegro Bus motorhomes with certain Cummins L9 diesel engines for a potential fuel leak that could cause a fire. The leak occurs between the fuel pump and remote filter head.
Product
TIFFIN — 2022 TIFFIN PHAETON
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·21V547000·2021-07-20
School Bus Parking Brake May Fail, Increasing Crash Risk
Daimler Trucks is recalling 267 school buses because the parking brake activation switch may fail to set the parking brake, increasing the risk of unintended vehicle movement and crashes.
Product
THOMAS BUILT BUSES — 2022 THOMAS BUILT BUSES SAF-T-LINER C2
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·21V546000·2021-07-20
2022 Kenworth Medium-Duty Trucks Windshield Defrost Failure Recall
Certain 2022 Kenworth T680, T880, and W990 trucks have defective HVAC controls that may fail to operate the windshield defrost system, reducing driver visibility and increasing crash risk. PACCAR is replacing the HVAC control heads free of charge.
Product
KENWORTH — 2022 KENWORTH T880
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·21V542000·2021-07-20
2021 Newmar Ventana motorhomes recalled for loose tie rod clamps
Newmar Corporation is recalling certain 2021 Ventana motorhomes because tie rod clamps may be loose, potentially causing tie rod ends to break or detach and resulting in steering loss.
Product
NEWMAR — 2021 NEWMAR VENTANA
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·21V534000·2021-07-15
2020–2021 Lincoln Aviator Wire Harness May Contact Compressor, Increasing Fire Risk
2020–2021 Lincoln Aviators with 3.0L engines may have improperly secured wire harnesses that can contact the A/C compressor pulley, risking electrical damage and fire. Ford will inspect and secure the harness free of charge.
Product
LINCOLN — 2020 LINCOLN AVIATOR
Category
Vehicle
Distribution
Distributed nationwide

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