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.
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.
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.
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.
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 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.
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.
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.
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.
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 is recalling HealthyWiser KetoFast Ketone Test Strips because they were distributed without FDA authorization and lack documentation of proper manufacturing and quality control.
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 Inc. is recalling multiple diagnostic test strips (breastmilk alcohol, SARS-CoV-2 antibody, and ketone tests) distributed in the U.S. and Taiwan because the company is closing and cannot provide documentation of manufacturing compliance or post-market surveillance records.
Medtronic is recalling Grafton DBM Putty bone matrix implants because the outer Tyvek pouch inspection step may not have been performed, potentially releasing non-conforming batches.
Medtronic is recalling 377 units of Grafton DMB Matrix demineralized bone matrix devices due to potential defects in the outer Tyvek pouch from a missed manufacturing inspection step. No patient injuries have been reported.
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.
Denver Solutions recalls 6,276 IV bags of oxytocin due to a labeling defect. The product was distributed nationwide to healthcare facilities.
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.
Denver Solutions is recalling 33,480 Vancomycin HCI IV bags (NDC 71449-028-68) due to a labeling issue. The affected lots were distributed nationwide.
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.
West-Ward Columbus Inc is recalling Methotrexate Sodium 2.5 mg tablets because some tablets have unsmooth surfaces and illegible identification markings. The recall affects 2,673 cartons distributed to MS and OH.
Denver Solutions, LLC is recalling 25,908 Vancomycin HCI IV bags distributed nationwide due to a labeling issue. Affected lots include products with expiration dates from October 2023 through January 2024.
Sheng Kee Bakery mooncakes recalled for undeclared egg allergen across CA, IL, TX, GA, WA, and NJ. Consumers with egg allergies should not consume.
Sheng Kee Bakery is recalling Large 4-Red Bean Mooncake Gift Boxes distributed in six states due to undeclared egg allergen. Consumers with egg allergies should not consume the product.
Sapphire Infusion Pumps with software revisions 16.10.1 or 16.10.2 may fail to detect air in the infusion line, potentially causing life-threatening air embolism. Approximately 1,383 units have been distributed nationwide.
Sheng Kee of California is recalling Large 4-Date Mooncake Gift Boxes due to undeclared egg allergen. The product was distributed to multiple U.S. states.