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

13426–13450 of 13802

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-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-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-2053-2021·2021-07-21
MRI Scanner Patient Orientation Button Confusion May Flip Diagnostic Images
GE Healthcare recalls 311 SIGNA Architect MRI scanners due to button confusion that may result in flipped diagnostic images. The 'Patient Orientation' button may be accidentally clicked instead of 'Save RX', causing incorrect image orientation.
Product
SIGNA Architect - 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-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
HighFDA (Devices)·Z-2070-2021·2021-07-21
Arrow Bipolar Balloon Electrode Catheter Recalled for Marketing Without FDA 510K Clearance
Arrow International is recalling 4 units of an electrode catheter marketed without FDA 510(k) clearance. The device was intended for electrophysiology studies.
Product
Arrow Bipolar Balloon Electrode Catheter 5 Fr. 105 cm, Product Code: AI-07154 - 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-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 (Devices)·Z-2046-2021·2021-07-21
Canon MRI System Recalled for Flame-Retardancy Component Defect
Canon Medical System recalled its Vantage Titan 3T MRI systems due to a component lacking proper flame-retardancy standards. The defect could produce smoke or fire during use.
Product
Canon Vantage Titan 3T, Premium Open-Bore MRI System, REF: MRT-3010 - 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 syste
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2049-2021·2021-07-21
Silicone thoracic/abdominal catheter recall due to potential sterilization defect
RanD S.r.l. is recalling Ch24 round silicone catheters used in thoracic and abdominal cavity drainage due to a sterilization process quality issue. Some units in affected lots may not be sterile.
Product
Ch24 round silicone catheter, Diameter: 8 mm, Perforated section: 230 mm, Total length: 600 mm, Reference Code R9900099. Thoracic/abdominal cavity drain catheter.
Category
Medical Device
Distribution
4 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-2056-2021·2021-07-21
GE Discovery MR750 MRI Scanner Button Error May Produce Flipped Images
GE Healthcare recalled 248 units of the Discovery MR750 3.0T scanner due to a button-confusion error where the Patient Orientation button may be clicked instead of Save RX, potentially resulting in incorrectly oriented or flipped images. No injuries reported.
Product
Discovery MR750 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-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-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-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-2062-2021·2021-07-21
MRI System User Interface Error May Cause Incorrectly Flipped Images
GE Healthcare SIGNA Voyager MRI systems may display flipped or incorrectly annotated diagnostic images due to button confusion on the system interface. 541 devices are affected worldwide.
Product
SIGNA Voyager, 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-2048-2021·2021-07-21
Hang&Go Hyperthermic Perfusion Kit Recall Due to Sterilization Failure
RanD S.r.l. is recalling Hang&Go hyperthermic perfusion kits due to a sterilization process failure that may have left some units non-sterile. The recall affects 72 kits distributed to Florida, Illinois, Tennessee, and Wisconsin.
Product
Hang&Go (kit for hyperthermic perfusion), Reference Code R9900120
Category
Medical Device
Distribution
4 states
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
HighFDA (Devices)·Z-2064-2021·2021-07-21
MRI System Patient Orientation Button May Cause Flipped Images
GE Healthcare's Discovery MR450 1.5T MRI system may inadvertently change patient orientation when users click the wrong button, resulting in flipped or incorrectly annotated images that could affect diagnostic accuracy.
Product
Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
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-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-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-2058-2021·2021-07-21
MRI Imaging System UI Defect May Cause Incorrect Image Orientation
GE Healthcare recalled 1,737 SIGNA Creator and SIGNA Explorer MRI systems due to a software bug where the 'Patient Orientation' button can be accidentally clicked instead of 'Save RX,' potentially causing incorrectly oriented diagnostic images.
Product
SIGNA Creator, SIGNA Explorer, Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2066-2021·2021-07-21
Medical Device Recall: Lingen Disposable Virus Sampling Kit, No 510(k) Clearance
The Lingen Disposable Virus Sampling Kit by Mercedes Medical was voluntarily recalled due to lacking FDA 510(k) clearance. The recall affected approximately 11,711 boxes distributed nationwide and internationally.
Product
Lingen Disposable Virus Sampling Kit, Item MTM-04, 40 tubes/box.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2067-2021·2021-07-21
Medical device recall: Lingen SAMPLE Virus Sampling Kit lacks FDA clearance
Mercedes Medical voluntarily recalled Lingen SAMPLE Virus Sampling Kits due to lack of FDA 510(k) clearance. The recall affects units distributed nationwide and internationally.
Product
Lingen SAMPLE Disposable Virus Sampling Kit pack, Item SAM ENI MTM-04, containing 2 tubes and 2 swabs/pack; and SAM ENI MTM04TUBE, containing 1 tube/pack.
Category
Medical Device
Distribution
Distributed nationwide

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13426–13450 of 13802