Agency
The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.
The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.
FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.
Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.
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.
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 diagnostic tests distributed without FDA authorization and lacking required quality system documentation. The company is ceasing operations and cannot fulfill post-market responsibilities.
Universal Meditech Inc. is recalling the DiagnosUS SARS-CoV-2 Antibody Test because the devices were distributed without marketing authorization and the manufacturer cannot verify manufacturing compliance or post-market safety oversight.
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.
Smith & Nephew recalled 28 JOURNEY II knee prosthesis inserts because two different articular types were mislabeled and swapped during packaging. The incorrect labeling prevents identification of the actual insert type.
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.
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 is recalling multiple diagnostic test strips distributed without FDA authorization. The company is closing and cannot provide documentation of manufacturing quality or post-market monitoring.
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.
GE Healthcare's Universal Viewer Workflow Manager medical imaging software may show the wrong patient's information when third-party reporting applications are used. This data mismatch could cause confusion during medical procedures.
Multiple diagnostic test products recalled due to company closure and inability to provide manufacturing and quality control documentation.
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.
Universal Meditech Inc. is recalling DeTec hCG pregnancy test cassettes due to unverified marketing authorization and missing manufacturing documentation. Device performance characteristics cannot be confirmed.
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.
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.
Universal Meditech Inc. is recalling PrestiBio Rapid Detection Pregnancy Test Midstream kits (manufactured after March 2021) because the company distributed them without FDA authorization and cannot verify manufacturing compliance.
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.
Diagnostic test strips by Universal Meditech are recalled for unverified performance and manufacturing non-compliance. The firm is going out of business.
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.
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.
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.
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.
Medtronic is recalling 77 units of Grafton DBM (Flex) due to a potential failure to perform required inspection of the outer Tyvek sterile pouch. Affected units may not meet sterile packaging standards.
American Contract Systems recalls Pediatric Heart SJH components exposed to improper sterilization, risking functionality loss and reduced drug efficacy.