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.
Today's Frozen Desserts, Inc. is recalling Premium Grapenut Special frozen dessert sold in Florida because it contains undeclared Yellow 5 and Yellow 6 artificial colorants that are not listed on the label.
Breckenridge Pharmaceutical is recalling 7,107 bottles of Duloxetine 20mg delayed-release capsules nationwide due to N-nitroso-duloxetine impurity exceeding FDA interim limits. No illnesses have been reported.
Merit Medical Systems recalled 12,910 MONARCH Inflation Devices worldwide due to a potential hole in the sterile barrier. The defect could expose the device to pathogens and pyrogens, potentially leading to infection.
Merit Medical Systems is recalling basixTOUCH Inflation Devices due to a potential hole in the sterile barrier. The defect may expose patients to pathogens and pyrogens, increasing infection risk.
Nova Ortho-Med is recalling 1,585 MONARCH ROLLATOR RED units because the backrest may disengage from its holder when users adjust from a slouched to upright position, creating a fall hazard.
Merit Medical Systems is recalling 202 StabiliT TOUCH Syringes with potential small holes in the sterile barrier. Affected devices may expose users to pathogens and pyrogens, which could cause infection.
Boston Scientific recalls 161 AVVIGO+ Multi-Modality Guidance Systems due to a software error causing an incorrect grid overlay display in Live and Record modes. The error affects measurement reference accuracy during intravascular imaging procedures.
Lemonland Food Corp is recalling Seasoned Sesame Leaves and Seasoned Perilla Leaves due to undeclared monosodium glutamate (MSG). The product was distributed in Washington.
Medline Industries recalls Heart Overhead Table Packs due to incorrect labeling. Some kits were marked as model 30000 when they should be model 30001.
Walmart is recalling Great Value Diced Peaches, Mandarin Segments, & Cherry Mixed Fruits Variety Pack because FD&C Red No. 3 was not declared on the label. The recall affects 511,164 units distributed nationwide.
Today's Frozen Desserts recalls Rum Nut Ice Cream distributed in Florida due to undeclared Yellow 5 and Yellow 6 food colorants. The recall affects 1,363 units with expiration dates from June 13 to September 13, 2025.
Beckman Coulter IRISPEC urine chemistry control materials may intermittently fail to detect negative glucose, producing false positive control results that could delay patient test reporting.
Boston Scientific's AVVIGO+ guidance system is recalled because a software glitch causes an incorrect grid overlay display when used with an OptiCross 18 catheter. The correct overlay appears in Review mode, and no patient injuries have been reported.
Today's Frozen Desserts is recalling Premium Grapenut frozen dessert products sold in Florida due to undeclared Yellow 5 and Yellow 6 food coloring additives not listed on product labels.
Boston Scientific recalled the AVVIGO+ imaging guidance system due to a software defect that displays a 9-grid overlay instead of the correct 15-grid overlay when connected to OptiCross 18 catheters in Live or Record mode.
Walmart is recalling Great Value Cherry Mixed Fruit cups nationwide because FD&C Red No 3 was not declared as an ingredient on the label.
Medline Industries recalls MEDLINE KIT CV I II vessel cannulae kits because product for model 30001 was incorrectly labeled as model 30000 during manufacturing.
Viona Pharmaceuticals has voluntarily recalled 2,544 pumps of Dapsone Gel 7.5% (Lot #T400512) due to crystallization. The affected product was distributed in New York.
Today's Frozen Desserts has recalled Rum Raisin ice cream distributed in Florida due to undeclared Yellow 5 and Yellow 6 food colorants. Approximately 1,363 units are affected.
El Gallo Azul Cock Brand Queso Procesado processed cheese in 300g metal cans is recalled for non-English labeling. The product was distributed in Oregon.
Zyno Medical LLC is recalling the Z-800 Infusion System due to a defect in the air-in-line software algorithm. Approximately 34,994 units distributed nationwide are affected by this Class I FDA recall.
Innovation Bakers has recalled 7-Eleven Fudge Brownies with Chocolate Chip due to undeclared walnuts. The product was distributed to Southern California 7-Eleven stores and may cause allergic reactions in consumers with walnut allergies.
Vail-Bon Jie Yang Wan capsules have been recalled for containing undeclared dexamethasone and chlorpheniramine. The product was marketed without FDA approval.
Medline recalls Sterile Laparoscopy Packs due to a manufacturing defect in the Detachable Endo Pocket component. The tube may stretch from the pouch during surgical procedures, potentially affecting tissue collection.
GE Healthcare Centricity Universal Viewer Zero Footprint Client version 6.0 SP11.x may fail to show the latest diagnostic report by default when a study contains multiple DICOM structured reports in different series.