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.
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 Inc. is recalling PrestiBio Breast Milk Alcohol Test Strips because the company distributed them without FDA marketing authorization and cannot verify they were manufactured properly. The firm is ceasing operations and cannot fulfill post-market responsibilities.
Medtronic Sofamor Danek USA Inc is recalling specific batches of Grafton DBM Orthoblend, an orthopedic implant material, because a required sterile packaging inspection step may not have been performed according to specifications.
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.
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 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 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.
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.
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.
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.
Universal Meditech recalled 147,000 pregnancy tests lacking verified FDA clearance and quality documentation. The manufacturer is closing and cannot support post-market safety surveillance.
American Contract Systems is recalling LAVH surgical component kits because two components were subjected to improper sterilization temperatures and ethylene oxide exposure, potentially causing loss of functionality and higher chemical residuals.
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.
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.
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.
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 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.
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 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.
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.
Universal Meditech Inc. is recalling multiple diagnostic test kits distributed without FDA authorization. The firm is closing operations and cannot verify Quality System compliance or provide post-market support.
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.
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.
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 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.