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.
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.
American Contract Systems is recalling Cataract Pack convenience kits due to insufficient aeration time during sterilization. The affected units may not be properly sterilized.
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 compromise sterility. The recall affects 4,364 units distributed worldwide.
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 HealthCare's Discovery MR950 MRI system may incorrectly calculate heating safety limits when using certain imaging sequences in Low SAR Mode, potentially causing overheating of MR-conditional implants.
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.
Panaderia Guatemex is recalling Conchas Guatemala pastry products due to undeclared soy allergen. The recall affects 170 bags distributed in Georgia, Kentucky, and Tennessee.
GE HealthCare is recalling certain MR750 MRI systems with specific software versions. When using particular imaging sequences in Low SAR Mode without the Optimized T2 FLAIR option, the radiofrequency field can exceed safe limits, risking overheating of MR-conditional implants.
Izzio Artisan Bakery is recalling 9500 cases of Aldi Mixed Sourdough loaves due to potential plastic contamination. The affected products were distributed across seven states: Illinois, Michigan, Texas, Ohio, New Jersey, Florida, and Arizona.
Empower Pharmacy is recalling Estradiol Cypionate Injection due to lack of assurance of sterility. The recall affects 2,797 units distributed nationwide within the United States.
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.
Medline has recalled Centurion procedure kits containing syringes affected by an FDA safety alert. The syringes may leak, break, or have other quality defects, posing a risk to patient health.
GE SIGNA Voyager MRI systems may exceed prescribed radiofrequency limits under specific operating conditions, risking overheating of MR conditional implants. The issue occurs with certain imaging sequences when the Optimized T2 FLAIR option is disabled.
Integra LifeSciences has recalled 265 TruDi NAV Suction Instruments due to incorrect calibration. The miscalibrated units may display inaccurate position information during surgical navigation procedures.
GE HealthCare recalled SIGNA PET/MR systems with specific software versions due to a configuration issue that can cause RF energy to exceed safety limits, potentially overheating MR-conditional implants.
Siemens Luminos Agile Max x-ray imaging systems have a support arm that may unintentionally lower during display positioning, creating an injury risk.
Izzio Artisan Bakery is recalling Izzio Everything Rolls due to potential plastic contamination. Affected lot numbers are 24183C and 24183A.
Lipari Foods is recalling Premo Turkey & Swiss 6oz deli meat packages due to potential Salmonella contamination. No illnesses have been reported.
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.
GE Medical Systems recalled 2,146 SIGNA 1.5T MR systems that may overheat implants during certain imaging sequences in Low SAR mode due to a software defect in radiofrequency safety calculations.
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.
Medline Industries is recalling Centurion procedure kits due to defective plastic syringes affected by an FDA safety alert. The syringes may leak or break and pose a potential risk to patient health.
Lunds & Byerlys is recalling Grilled Chicken Caesar Salad that is mislabeled; it is actually Korean Shrimp Salad containing undeclared shellfish, tree nuts (cashew), soybeans, and sesame. Distributed in Minnesota, Lot 301335, Use By 12/04/23.