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.
Knockroe Inc is recalling Bonya Mango Yogurt Parfait (8oz) because it contains undeclared almonds, a major food allergen. The product was distributed to NY, PA, MA, and NJ.
Knockroe Inc is recalling Bonya Coconut Yogurt Parfait (8 oz) distributed to NY, PA, MA, and NJ because it contains undeclared almonds, a common allergen.
Empower Pharmacy is recalling Testosterone Cypionate Injection 200 mg/mL (Lot 202364, 8,230 vials) distributed nationwide because the manufacturer cannot assure the product's sterility. Consumers should stop using the product and consult their healthcare provider.
Knockroe Inc is recalling Bonya Strawberry Yogurt Parfait cups (8 oz) distributed to NY, PA, MA, and NJ because they contain undeclared almonds, a common allergen.
LeMaitre Vascular is recalling TufTex Over-the-Wire Embolectomy Catheters due to incomplete seals on some packages that compromise the sterile barrier. Affected units were distributed nationwide and internationally.
Knockroe Inc is recalling Bonya Peach Yogurt Parfait (8oz cups) distributed to NY, PA, MA, and NJ due to undeclared almonds that may pose a risk to consumers with tree nut allergies.
Knockroe Inc is recalling Bonya Blueberry Yogurt Parfait (8 oz) distributed in NY, PA, MA, and NJ because the product contains undeclared almonds, which poses a risk to consumers with tree nut allergies.
Vyaire Medical is recalling the AirLife Infant Heated Wire Circuit (Model AH165) because adapters may disconnect during setup or use, interrupting ventilation to infants and potentially causing severe complications.
Knockroe Inc is recalling Bonya Pineapple Yogurt Parfait (8oz cups) distributed to NY, PA, MA, and NJ because the product contains undeclared almonds, a common allergen that is not listed on the label.
Medical Depot Inc. is recalling 89,532 units of the iGo2 DC Car Adapter used with iGo2 Portable Oxygen Concentrator Systems. The DC power supply housing may become excessively hot to the touch and deform, posing a burn and fire hazard.
Baxter Healthcare Corporation is recalling the Welch Allyn Life2000 Ventilation system due to a cybersecurity vulnerability discovered through internal testing. The recall affects 4,881 units distributed worldwide.
Knockroe Inc is recalling Bonya Lemon Yogurt Parfait (8oz) because it contains undeclared almonds, a common allergen. The product was distributed to New York, Pennsylvania, Massachusetts, and New Jersey.
ICU Medical is recalling LifeShield Drug Library Management software v2.1 and v2.2 due to defects that could allow over-delivery of medication to patients or unauthorized modification of drug parameters.
Wells Enterprises, Inc. is recalling Ellington Farms Vanilla Flavored Ice Cream (3-gallon tubs) distributed across the US because plastic material may be present in the product.
Advance Food International Inc. is recalling Kasundi Peeled Mango Pickle in Oil due to elevated lead levels detected in the product. The affected product was distributed in the Northeast.
Wells Enterprises is recalling Vanilla Frozen Yogurt 3-gallon tubs due to the possible presence of plastic material in the product.
Philips is recalling Intera 1.0T Power/Pulsar MRI systems (Model 781103) due to potential failure of the Quadrature Body Coil seal adhesive, which may create sharp edges and injure patients during scanning.
Philips is recalling the Intera 1.5T Omni/Stellar MRI scanner due to potential failure of the Quadrature Body Coil seal adhesive, which may create sharp edges and cause patient injury. The loose seal during scanning could result in skin abrasions, bruises, lacerations, hair loss, or tissue damage.
New England Village Snacks The 19th Hole Snack Mix (5 oz. and 10 oz.) is being recalled due to undeclared almonds and sesame. Consumers with allergies to these ingredients should not consume the product.
Philips is recalling Intera 1.5T MRI systems due to potential failure of the Quadrature Body Coil seal adhesive, which may create sharp edges and contact patient skin during scanning.
Philips is recalling SmartPath to dStream 1.5T MRI units (Model 782146) because the Quadrature Body Coil seal adhesive may fail, creating sharp edges that could cause skin abrasions, lacerations, or tissue injury to patients.
Abbott Molecular is recalling the Alinity m Resp-4-Plex AMP Kit (List Number 09N79-096) due to reports of increased reactive negative controls and false positive results in respiratory viral testing.
Wells Enterprises is recalling Glenview Farms Chocolate Ice Cream 3-gallon tubs due to possible plastic foreign material in the product. The affected ice cream was distributed to 103 distribution centers across the United States.
LeMaitre Vascular is recalling Pruitt Occlusion Catheters (catalog numbers 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56) because some packages have incomplete sterile barrier seals, potentially compromising product sterility.
Cook Incorporated is recalling Tornado Embolization Microcoils due to incorrectly sized coils in affected lots. The devices are used for vascular embolization procedures.