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.
Luminex recalls approximately 1,100 diagnostic kits due to defective test cartridges that may produce false positive results for Staphylococcus lugdunensis and Enterococcus faecium bacteria.
GE SIGNA MR380 MRI systems with software versions SV25.5 or SV25.6 may exceed radiofrequency heating limits during certain imaging sequences, potentially causing MR-conditional implants to overheat. The issue occurs in Low SAR Mode when specific T2 FLAIR sequences are used with the Optimized T2 FLAIR option disabled.
Nuts.com is recalling Ground Sumac products due to undeclared gluten. Products were distributed online to consumers in multiple U.S. states, Canada, and the U.S. Virgin Islands.
Panaderia Guatemex is recalling Champurradas due to the presence of undeclared soy allergen. The recall affects 170 bags distributed in Georgia, Kentucky, and Tennessee.
Baxter Healthcare is recalling the SIGMA Spectrum Infusion Pump (Serial 2158913) distributed nationwide in Florida. The recall is due to improperly performed testing procedures prior to release, which may affect device function.
CareFusion's BD PYXIS MEDBANK medication dispensing cabinets (software 3.9.1.9) have a software defect that may cause restock labels to print incorrect medication bin locations, creating a risk of medication dispensing errors.
GE Medical Systems is recalling 3.0T SIGNA HDxt MRI systems because radiofrequency energy can exceed safety limits under specific operating conditions, potentially overheating implanted medical devices in patients.
Steris Corporation recalls 129 Hookup devices (Model 2-8-540HAN) due to incorrect hookup instructions in product documentation. Using wrong connections may prevent proper endoscope disinfection, creating infection risk.
CareFusion is recalling BD PYXIS MEDBANK medication dispensing cabinets due to a software issue that causes incorrect bin information to print on restock labels, potentially leading to medication selection errors.
A software defect in BD PYXIS MEDBANK automated medication dispensing cabinets may cause the incorrect medication bin to be printed on restock labels, potentially resulting in medication errors.
A software defect in the BD PYXIS MEDBANK automated dispensing cabinet causes incorrect medication bin locations to be printed on restock labels, potentially resulting in medication dispensing errors. No illnesses or injuries have been reported.
Siemens Luminos Agile Max x-ray imaging systems have a support arm that may unintentionally lower during display positioning, creating an injury risk.
Steris recalls Hookup Model 2-8-540CAS endoscope reprocessor units due to incorrect instructions that could prevent proper disinfection. Using incorrect hookup connections may lead to patient contamination or infection risk.
A software issue in BD PYXIS MEDBANK automated medication dispensing cabinets can cause incorrect medication bin labels on restock labels, potentially leading to medication storage errors.
A software issue in BD PYXIS MEDBANK automated dispensing cabinets can cause incorrect medication bin labels to print during restocking. This could lead to medication dispensing errors in healthcare facilities.
A software error in CareFusion's BD PYXIS automated medication dispensing cabinet can cause incorrect medication bin numbers to be printed on restock labels, risking medication dispensing errors.
Favorite Day Bakery White Fudge Mini Cookies (7oz) recalled nationwide in the US and Canada due to potential salmonella contamination.
GE Optima MR360 MRI systems with affected software versions may exceed safe radiofrequency energy limits, potentially overheating MR-conditional implants when specific imaging sequences are used. 469 units are affected worldwide.
American Contract Systems is recalling Cataract Pack convenience kits due to insufficient aeration time during sterilization. The affected units may not be properly sterilized.
Philips IntelliVue Patient Monitors (models MX400/450/500/550) with software versions L.x or M.x are missing three monitoring capability options (MOS, M06, M20) due to software changes, creating potential for delayed or incorrect treatment. The recall involves 18 units distributed nationwide and internationally.
GE SIGNA MR360 MRI systems with software versions SV25.5 or SV25.6 may exceed prescribed RF exposure limits in certain scan configurations, potentially overheating MR-conditional implants. The recall affects 81 units worldwide.
Olympus is recalling Everest Bipolar Cutting Forceps due to fractures and breakages in packaging trays and Tyvek covers that may result in a sterility breach. Approximately 6985 units are affected and were distributed worldwide.
American Contract Systems is recalling Special Procedure Pack convenience kits due to insufficient aeration time during sterilization, which may have compromised sterility. Distributed in California, Kansas, Maine, Minnesota, Missouri, Nebraska, and South Dakota.
BD PYXIS MEDBANK automated medication dispensers may print incorrect medication bin labels due to a software defect, risking medication handling errors in healthcare settings.
CareFusion is recalling 232 automated medication dispensing cabinets due to a software issue that may print incorrect medication bin labels, potentially causing medication dispensing errors.