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.
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.
Minimum severity
GE Healthcare is recalling 55 SIGNA Excite 3T MRI systems due to potential for images to be flipped left to right, which could affect diagnostic accuracy. The affected systems were distributed worldwide.
Ventana Medical Systems has recalled 9,214 BenchMark ULTRA and DISCOVERY ULTRA instruments due to potential fluid leak that could cause electrical short circuit, smoke, and fire.
Shimadzu Medical Systems recalls 176 SonialVision G4 X-ray systems that may emit radiation doses exceeding federal standards in some fluoroscopic mode cases. No injuries have been reported.
Philips Allura and Azurion X-ray systems running StentBoost Live R2.0 may display images from previous scans or other patients due to a software defect. 338 units are affected and globally distributed.
Maquet Cardiovascular is recalling the Ultima Activator II Reusable Drive Mechanism due to potential corrosion on pins, which could cause allergic reactions, metal toxicity, and other delayed health effects.
Philips Healthcare is recalling the StentBoost Live R2.0 application due to a software configuration error. The imaging system fails to stop image acquisition automatically, continuing indefinitely while the pedal is pressed instead of stopping after 40 images.
DeRoyal Industries is recalling 1,360 DEXMED ACCESS CENTER TRAY kits with Prevantics antiseptic swabs due to uncertain validation of manufacturing test methods. The affected kits were distributed in Florida, New Jersey, and Tennessee.
Shimadzu FLUOROspeed X1 fluoroscopy systems may deliver radiation doses exceeding federal regulatory limits in specific fluoroscopic operating modes due to inadequate installation adjustment criteria.
Stradis Medical is recalling 76 units of Total Knee Surgical Kits with potentially perforated or torn outer bags that may compromise sterility. Distribution occurred in Indiana, Texas, and Pennsylvania.
Stradis Medical is recalling Anterior Hip Pack surgical kits due to perforated or torn outer bags that may compromise sterility. No illnesses have been reported.
GE Healthcare Revolution CT scanners display inaccurate radiation dose values in certain situations. This could affect clinical dosing decisions during patient scans.
GE Healthcare's 1.5T and 3.0T SIGNA Excite HD MRI systems may display medical images flipped left to right, potentially affecting diagnostic accuracy. The recall involves 76 units distributed worldwide.
Abbott Molecular recalled Alinity m HBV Application Specification Files due to potential for incorrect high quantitation results on negative samples, which could affect test accuracy for hepatitis B virus detection.
SyncVision cardiac imaging systems may display incorrect measurements during same-session procedures if workflow steps are performed out of order, potentially affecting patient treatment.
Abbott is recalling 402 kits of ARCHITECT STAT myoglobin calibrator that failed stability testing and may produce out-of-specification calibration results. The affected calibrators could impact the accuracy of myoglobin measurements used in clinical diagnostics.
Brius Technologies is recalling Brius Patient Specific Brackets that were sold before the company completed the required design control process and regulatory documentation.
Abbott is recalling 529 units of the Amplatzer Steerable Delivery Sheath (Class II) distributed outside the US due to an update to the device's instructions for use.
The YSIO X.Pree x-ray system's user interface displays incorrect collimation information during image acquisition. While actual collimation functions correctly, the display does not match preset parameters, potentially confusing operators.
Brius Technologies recalls Brius Pontics custom orthodontic devices that were sold before completing required design control procedures and documentation.
SA3, LLC is recalling Silatrix Oral Gel Polymerized Sucralfate Gel due to failed microbial testing. Consumers should not use the product and contact their healthcare provider or SA3, LLC.
Cook Medical recalled 24,641 Gunther Tulip Vena Cava Filter Sets due to updates required in the Instruction for Use documentation covering device description, indications, contraindications, warnings, and precautions.
Cook Medical is recalling Celect Platinum Vena Cava Filter Sets due to revisions needed in the instructions for use, including updates to contraindications, warnings, precautions, and potential adverse events.
Siemens recalls magnesium reagent cartridges due to imprecision and abnormal assay flags that may cause erroneous diagnostic results and require repeat patient testing.
Avanos Medical is recalling 2,520 BALLARD Multi-Access Port Catheters due to incorrect expiration dates on the packaging. No illnesses or injuries have been reported. Patients should verify the lot number and contact their healthcare provider.
RayStation/RayPlan radiation therapy software (versions 4–11A) may incorrectly calculate radiation dose density in treatment planning. The error affects dose calculations in regions partially covered by certain structures.