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
Beckman Coulter is recalling 50 CellMek SPS Sample Preparation Systems because a software error dispenses samples close to or touching tube bottoms, removing 60-100 microliters from the final sample.
Vortex Surgical is recalling 14,789 units because there may be voids in the seal of the Tyvek pouches, which compromises the sterile barrier.
Fujirebio Diagnostics is recalling 23 units of Lumipulse G pTau217/beta-Amyloid 1-42 Plasma Ratio because falsely elevated ratio results can incorrectly classify a patient as having amyloid pathology.
Changchun Wancheng Bio-Electron is recalling 500 units of the Vivoo pH Test because tests requiring a 510(k) were distributed before they could be legally marketed.
Changchun Wancheng Bio-Electron is recalling 1,000 units of the S. Typhi/Para Typhi A Antigen test because it was distributed before it could be legally marketed.
Vortex Surgical is recalling 14,789 units because there may be voids in the seal of the Tyvek pouches, which compromises the sterile barrier.
Focalyx Technologies is recalling 18 units of Focalyx Fusion because accessories may not function properly with Windows 10, which may cause patient harm during biopsy or delay treatment.
Changchun Wancheng Bio-Electron is recalling 1,000 units covering the Male Fertility Sperm Test for Home Use (Cassette) because tests requiring a 510(k) were distributed before they could be legally marketed.
Encore Medical is recalling 19 EMPOWR 3D Knee Tibial Inserts because several acetabular system and knee insert devices may have a packaging discrepancy.
Changchun Wancheng Bio-Electron is recalling 1,000 units of the Menopause Test Cassette (Urine) because tests requiring a 510(k) were distributed before they could be legally marketed.
Changchun Wancheng Bio-Electron is recalling 1,000 units of the LH One Step Ovulation Test Device (Urine) because tests requiring a 510(k) were distributed before they could be legally marketed.
Fujirebio Diagnostics is recalling 128 units of Lumipulse G beta-Amyloid 1-42-N Plasma Calibrators because falsely elevated ratio results can incorrectly classify a patient as having amyloid pathology.
Vortex Surgical is recalling 14,789 units because there may be voids in the seal of the Tyvek pouches, which compromises the sterile barrier.
Olympus is recalling the Single Use Electrosurgical Knife KD-640L because deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
Intuitive Surgical is recalling 219 da Vinci X, Xi and da Vinci 5 systems because a software error allowed instrument arms failing an important diagnostic test to remain in clinical use.
Vortex Surgical is recalling 14,789 units because there may be voids in the seal of the Tyvek pouches, which compromises the sterile barrier.
Fujirebio Diagnostics is recalling 1,423 units of Lumipulse G beta-Amyloid 1-42-N Plasma Immunoreaction Cartridges because falsely elevated ratio results can incorrectly classify a patient as having amyloid pathology.
Vortex Surgical is recalling 14,789 units because there may be voids in the seal of the Tyvek pouches, which compromises the sterile barrier.
Fujirebio Diagnostics is recalling 1,569 units of Lumipulse G pTau 217 Plasma Immunoreaction Cartridges because falsely elevated ratio results can incorrectly classify a patient as having amyloid pathology.
Fujirebio Diagnostics is recalling 179 units of Lumipulse beta-Amyloid Plasma Controls because falsely elevated ratio results can incorrectly classify a patient as having amyloid pathology.
Changchun Wancheng Bio-Electron is recalling 91,366 units of LotFancy Urinary Tract Infection Urine (UTI) Test Strips because tests requiring a 510(k) were distributed before they could be legally marketed.
Encore Medical is recalling 49 EMPOWR acetabular system liners after a package labeled 942-01-40G was found to contain a 942-01-36H liner.
Vortex Surgical is recalling 14,789 units because there may be voids in the seal of the Tyvek pouches, which compromises the sterile barrier.
Medtronic MiniMed is recalling 577 MiniMed 780G insulin pumps on software version 6.60 because a timing and processor communication issue may trigger Pump Error 43 or 41, suspending insulin delivery.
Changchun Wancheng Bio-Electron is recalling 4,800 units of the Exploro Highly Sensitive Male Fertility / Sperm Concentration Test because tests requiring a 510(k) were distributed before they could be legally marketed.