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
SynCardia Systems is recalling 114 units of the SynCardia 50cc TAH-t artificial heart because it contains an epoxy resin that has not been reviewed by the FDA for safety and efficacy.
Preat Corp is recalling 23 Neodent GM x 4mm Healing Abutments due to a dimensional defect that may allow microleakage between the abutment and implant. Affected units were distributed to dental practices in multiple US states.
Penzeys, Ltd. is recalling Brady Street Cheese Sprinkle because it may contain sesame, which is not declared on the label. People with sesame allergies should not consume this product.
Medtronic is recalling Grafton DBM Crunch bone matrix surgical implants due to potential packaging defects in the outer Tyvek pouch. An inspection step may not have been completed according to requirements.
Universal Meditech Inc. is recalling DiagnosUS Ovulation Predictor Midstream devices due to lack of FDA marketing authorization and inability to verify manufacturing compliance. The manufacturer is ceasing operations.
Centricity PACS-IW medical imaging software versions may store images from two different patients within a single study, creating potential clinical confusion during diagnostic review.
Preat Corp is recalling Preat REF 9007121 Neodent GM x 2mm Healing Abutments due to a dimensional condition that may create a gap between the abutment and implant, potentially allowing microleakage. Affected devices were distributed in multiple US states.
Diagnostic test strips by Universal Meditech are recalled for unverified performance and manufacturing non-compliance. The firm is going out of business.
Medtronic is recalling Grafton Plus DBM Paste due to a missed inspection step on the outer packaging. The outer Tyvek pouch may have non-conformances that could affect product integrity.
Biomic Sciences is recalling Restore Sinus Spray due to microbial contamination of the non-sterile product. The product is distributed nationwide and internationally.
American Contract Systems recalls Pediatric Heart SJH components exposed to improper sterilization, risking functionality loss and reduced drug efficacy.
Smiths Medical is recalling 31,900 Portex Pro-Vent Arterial Blood Sampling Kits due to missing filter components. Kits without the filter can produce inaccurate test results or expose users to infectious blood.
The Maquet Acrobat-i Vacuum Stabilizer System's housing mount jaw may break during cardiac surgery, risking injury to heart tissue, blood vessels, or bypass grafts.
American Contract Systems is recalling Pediatric Urology Wolson Packs due to components being exposed to unapproved sterilization processes. Components may have lost functionality or reduced efficacy, potentially compromising device performance.
Universal Meditech Inc. is recalling PrestiBio URINALASYS TEST STRIP 10 PARAMETERS due to missing manufacturing documentation and unverified device performance. The manufacturer is ceasing operations and cannot demonstrate the devices meet quality standards.
Universal Meditech Inc. is recalling To Life hCG pregnancy test strips because the company is ceasing operations and cannot verify manufacturing compliance. The firm cannot provide documentation of manufacturing standards, storage conditions, or post-market safety monitoring.
Preat Corp is recalling Neodent dental healing abutments (REF 9007124) due to a dimensional condition that may cause gaps between the abutment and implant, potentially allowing microleakage.
GE Healthcare Centricity Universal Viewer software versions 6.0 SP0-SP7.1 may combine radiological images from different patients into a single study, potentially affecting patient care and diagnosis.
Universal Meditech Inc. is recalling multiple diagnostic test products distributed without FDA authorization or documented quality system compliance. The company is unable to provide manufacturing or post-market surveillance documentation.
American Contract Systems is recalling Breast Plastics Pack components because they were subjected to inappropriate sterilization that may cause loss of functionality or drug efficacy and increased ethylene oxide residuals.
Universal Meditech is recalling HealthyWiser KetoFast Ketone Test Strips because they were distributed without FDA authorization and lack documentation of proper manufacturing and quality control.
Betty Lou's Inc. recalls Stabilyze Sugar Stable Dark Chocolate Peanut Butter due to undeclared sesame. The product was distributed across 26 states; consumers with sesame allergies should not consume it.
Universal Meditech Inc. is recalling the Am I Pregnant? One Step HCG Pregnancy Test because the company is going out of business and cannot verify manufacturing compliance or provide quality system documentation.
Universal Meditech is recalling DiagnosUS hCG pregnancy test cassettes distributed without proper FDA authorization and quality documentation. The company is closing and cannot provide manufacturing records or post-market surveillance data.
American Contract Systems recalled General Pack medical device components (I.V. catheters and adhesive) that were improperly sterilized with ethylene oxide at higher than approved temperatures. The components may lack functionality or have elevated sterilization residuals.