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
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.
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.
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.
GE Healthcare's Centricity Universal Viewer Workflow Manager may display exam information for a different patient when third-party reporting applications launch exams. The mismatch could lead to incorrect patient identification.
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.
GE Healthcare is recalling Centricity PACS-IW radiological imaging software versions V3.7.x through 3.7.3.9 SP3 because images from different patients may appear together in a single study, risking patient misidentification.
Universal Meditech Inc. recalls DiagnosUS hCG Pregnancy Test cassettes distributed in eight U.S. states due to lack of manufacturing documentation and unknown performance characteristics. The firm is going out of business.
Omega Medical Imaging recalls monitor boom systems where the actuator can separate from the pivot mechanism, allowing the boom to detach. The defect affects units manufactured between October 2012 and July 2019.
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.
Universal Meditech Inc. is recalling 40,000 OMTMO ovulation test strips because the manufacturer is closing operations and cannot provide required manufacturing and quality documentation.
Carl Zeiss OPMI LUMERA 300 surgical microscopes may have a missing screw on the suspension arm, potentially allowing suspended components to fall and injure nearby persons. Eight units distributed in Maryland, Texas, California, Georgia, and Louisiana are affected.
American Contract Systems recalls cardiovascular surgical device components that were subjected to improper ethylene oxide sterilization at excessive temperatures, potentially causing loss of functionality or drug efficacy.
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.
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.
American Contract Systems recalls Robotics Pack SAH components due to improper sterilization exposure. The IV catheter and adhesive components may lack functionality or contain excess sterilization residue.
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 Inc. is recalling diagnostic test strips due to Quality System violations and lack of manufacturing documentation. The company is closing and cannot provide post-market surveillance or support.
A surgical navigation system used in ENT procedures may display incorrect curette tip positions, potentially causing delayed surgery, cerebrospinal fluid leaks, vision loss, or skull damage. The recall affects 141 units across 30 US states.
Two medical device components in the Robotics Pack (I.V. Cath and Adhesive Dermabond) were improperly sterilized and may lose functionality or drug efficacy. Affected units distributed in Florida and Iowa.
Omega Medical Imaging is recalling 52 monitor suspension systems (Part Number 1000-0085) manufactured 2012–2019 in which the actuator may separate from the pivot mechanism. An installed safety cable contained one such failure, but the structural issue poses a falling hazard. No injuries reported.
American Contract Systems is recalling Sub Q Recorder Pack components that were improperly sterilized using ethylene oxide at excessive temperatures. The I.V. Cath and Dermabond components may lose functionality or drug efficacy as a result.
Universal Meditech Inc. recalled DiagnosUS hCG pregnancy test strips because the company distributed them without FDA marketing authorization and cannot provide manufacturing compliance documentation. The firm is ceasing operations.
Empatica has recalled 1,360 units of its Embrace2 seizure monitoring wearable due to potential battery life lasting less than the specified 48 hours, requiring more frequent charging.
Medtronic is recalling specific serial numbers of Grafton DBM Matrix Strips due to a potential defect in the outer Tyvek pouch resulting from a missed inspection step during manufacturing.