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
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.
American Contract Systems is recalling CVS PCSU SJH IV catheter and adhesive components due to improper ethylene oxide sterilization. The components may have reduced functionality or elevated chemical residuals.
Impedimed's SOZO Bilateral Arm L-Dex Software (versions 4.1 and 5.0) has inadequate sensitivity for detecting early lymphedema, which could delay treatment. The FDA is recalling 354 units distributed nationwide.
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.
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.
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.
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 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.
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.
Multiple diagnostic test products recalled due to company closure and inability to provide manufacturing and quality control documentation.
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 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.
Diagnostic test strips by Universal Meditech are recalled for unverified performance and manufacturing non-compliance. The firm is going out of business.
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.
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.
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. is recalling DiagnosUS Pregnancy Test Midstream kits (3,304 units) due to inability to verify marketing authorization and missing quality documentation. The company, which is closing, cannot fulfill post-market safety responsibilities.
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.
Universal Meditech Inc. is recalling PrestiBio Ketone Test Strips because they were distributed without FDA marketing authorization. The company is going out of business and cannot provide post-market support.
American Contract Systems recalls Pediatric Heart SJH components exposed to improper sterilization, risking functionality loss and reduced drug efficacy.
Smith & Nephew is recalling 29 units of a knee prosthesis component due to labeling and packaging errors where two product types were swapped during manufacturing.
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.
FDA is recalling DiagnosUS Ovulation Test Strips from Universal Meditech Inc. because the manufacturer cannot document that the devices were made according to quality standards. The company is ceasing operations and cannot fulfill post-market obligations.
Universal Meditech Inc. is recalling HealthyWiser UriTest™ UTI Test Strips due to missing documentation of Quality System compliance. The manufacturer is going out of business and cannot fulfill post-market safety obligations.
Universal Meditech Inc. is recalling diagnostic tests distributed without FDA authorization and lacking required quality system documentation. The company is ceasing operations and cannot fulfill post-market responsibilities.