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.
Milrinone Lactate Injection is recalled due to failed impurity and degradation specifications. The affected lot should not be used.
AvKARE is recalling Sodium Fluoride 1.1% prescription dental toothpaste because cartons are labeled as Capsaicin Cream 0.025%, though the tubes are correctly labeled. Approximately 35,184 tubes have been distributed to 19 consignees.
Ascend Laboratories is recalling Fosfomycin Tromethamine antibiotic granules nationwide due to organic impurities exceeding acceptable levels in stability testing. No illnesses have been reported.
Ruby Mountain Spring Water 3 and 5 gallon jugs are recalled due to positive coliform findings. Consumers should not drink the water.
PBM Nutritionals recalls Parent's Choice and Tippy Toes Sensitivity Premium Infant Formula due to inadvertent market release of product that had been rejected. Affected batches were distributed across multiple states.
Datascope Corp. is recalling Cardiosave Rescue Intra-Aortic Balloon Pumps due to system overheating alarms that can cause loss of pumping function and device shutdown.
Datascope is recalling Cardiosave Hybrid intra-aortic balloon pumps due to reported temperature alarms that can cause loss of pumping function or unexpected standby mode. Users have reported these system failures in critical cardiac support devices.
Datascope Corp. is recalling 9,175 units of Cardiosave Rescue IABP devices because batteries will not charge if the console is not fully inserted into the hospital cart. Users were often unaware of this insertion requirement.
Olympus Corporation recalls 6,426 units of the EVIS EXERA III Duodenovideoscope (Model TJF-Q190V) due to recent reports of patient infections. The device was distributed nationwide in the United States.
Datascope's Cardiosave Hybrid Intra-Aortic Balloon Pumps may trigger unexpected alarms indicating gas loss or gain due to undocumented causes including patient movement and blood in the circuit. The FDA Class I recall affects 9,175 units.
Datascope Corp. is recalling Cardiosave Hybrid intra-aortic balloon pumps due to autofill failure causing pump stops. The FDA Class I recall affects approximately 9,175 units distributed nationwide.
Stonewall Kitchen brand Peanut Butter Maltballs (6oz) may contain undeclared peanut, soy, and wheat. Consumers with allergies to these ingredients should not consume this product.
The FDA is recalling Vegetal Vigra 200mg capsules nationwide because they contain sildenafil, an active ingredient in FDA-approved medications. The product was marketed without FDA approval.
The Cardiosave Hybrid Intra-Aortic Balloon Pump console fails to charge if not fully inserted into the hospital cart. Users unaware of this requirement may attempt to use a non-charged device during critical cardiac care.
Datascope Corp. is recalling 9,175 Cardiosave Rescue Intra-Aortic Balloon Pumps due to autofill failures that can cause the pump to stop.
Datascope Corp. is recalling approximately 9,175 Cardiosave Rescue IABPs because unexpected gas-loss and gas-gain alarms may occur during therapy due to patient movement, blood in the circuit, and hardware issues.
Central Admixture Pharmacy Services is recalling 340 bags of epinephrine IV solution due to inadequate validation of sterilization procedures, creating a potential contamination risk.
Central Admixture Pharmacy Services is recalling 235 bags of diltiazem IV product due to lack of validation data for sanitization cycles. No illnesses have been reported.
Datascope Corp. is recalling 9,379 Cardiosave Hybrid Intra-Aortic Balloon Pumps due to a fiber optic sensor failure that may occur when inserting the balloon connector.
Stryker Corporation is recalling the SurgiCount+ Software Application due to potential miscounting of surgical sponges when scanning multiple items from the same package. The software may fail to accurately track RFID-tagged absorbent articles.
Central Admixture Pharmacy Services recalls Cardioplegia Solution due to inadequate validation of sterilization processes. One lot (36-262881) distributed nationwide may not be assured sterile.
Siemens Healthcare Diagnostics is recalling 11,824 units of Atellica CH Triglycerides test kits due to reagent carryover from other test parameters that can affect magnesium measurement accuracy. The FDA classified this as a Class II recall.
Siemens Healthcare Diagnostics is recalling epoc BGEM Test Cards for veterinary use due to potential inaccurate glucose results in lower-range samples. Affected units may report artificially elevated readings.
Lyons Magnus LLC is recalling Lyons Grape Juice in 4 fl oz plastic cups due to signs of bloating. The recall affects 1564 cases distributed across 13 states.
Smiths Medical recalls 66,633 PORTEX 0.5u Hydrophobic Disc Filters nationwide due to a labeling error where the barcode (UDI) does not correctly reflect the product expiration date.