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
Shimadzu FLUOROspeed X1 fluoroscopy systems may deliver radiation doses exceeding federal regulatory limits in specific fluoroscopic operating modes due to inadequate installation adjustment criteria.
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.
DeRoyal Industries is recalling 780 Ultra/Mammo Tray kits with antiseptic swabs due to uncertain validation of manufacturing test methods. Kits are used for patient skin preparation before surgery or injection.
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.
Stradis Medical is recalling Surgicare Neuro Pack neurological kits because the outer bag may be perforated or torn, potentially compromising product sterility. 176 units were distributed in Indiana, Texas, and Pennsylvania.
Siemens is recalling seven Symbia Intevo SPECT/CT imaging systems due to a quality defect in the bolts that secure the CT balancing weights, which could create a safety issue.
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.
Philips is recalling 331,712 infant and child defibrillator pads worldwide due to potential gel separation from the pad backing. The gel may fold onto itself or separate nearly completely, leaving reduced surface coverage on the pad.
RayStation and RayPlan radiation therapy planning software may calculate incorrect radiation doses due to a source-to-skin distance calculation error. The FDA Class II recall affects 149 units distributed in the US.
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.
Illumina is recalling 674 NextSeq 550Dx DNA sequence analyzers worldwide. A short circuit may occur after reconnecting circuit components, causing the device to become inoperable.
Human Care USA, Inc. is recalling the Hanger-Bar 2P 45cm due to a manufacturing defect allowing the set screw to loosen, creating a fall hazard.
Howmedica Osteonics is recalling 40 units of Biolox delta Ceramic V40 Femoral Head components where the size and/or offset may not match package labeling.
Medtronic MiniMed insulin pumps may be used without programmed basal rates, causing insulin under-delivery and potentially severe high blood sugar. Patients must configure and save basal settings before use, but labeling doesn't clearly explain this requirement.
Wright Medical is recalling 176 packs of the EasyFuse Dynamic Compression System Instrument Pack due to risk that the drill guide can jam and break during surgery.
RayStation radiation therapy planning software (versions 6-11A) may unexpectedly change jaw positions during optimization after dose or target modifications. Users should verify treatment plans carefully before delivery.
Edwards Lifesciences FORE-SIGHT ELITE Absolute Tissue Oximeter (Model 01-06-3000) is recalled because StO2 (tissue oxygen saturation) values may read inaccurately low when used with the large sensor on arms or legs, potentially leading to inappropriate treatment.
Mevion S250 and S250i Proton Therapy Systems hand pendants may malfunction, causing unintended motion of the therapy couch and nozzle. This poses a risk of patient injury if they contact moving equipment.
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.
Edwards Lifesciences is recalling 8,389 FORE-SIGHT ELITE Tissue Oximeter modules that may display inaccurately low oxygen saturation values when used in certain body locations, potentially leading to inappropriate treatment decisions.
Howmedica Osteonics is recalling certain Biolox delta Ceramic V40 Femoral Head components because the actual size and offset may not match the package label. Patients with these implants should contact their surgeon.
Diagnos Inc is recalling CARA retinal analysis software version 4.7.2 because some AI-based features may lack appropriate FDA market approval. Users are advised to revert to a prior software version.
Siemens recalls magnesium reagent cartridges due to imprecision and abnormal assay flags that may cause erroneous diagnostic results and require repeat patient testing.
Meridian Bioscience is recalling Revogene diagnostic devices due to compromised photomultiplier tubes that may produce false-positive or indeterminate test results.
Baxter Healthcare Corporation is recalling 1,399 Liko Universal Twinbar 670 QRH patient lift accessories due to an incorrect center bolt used during assembly. The defect could cause a patient to fall during use.