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.
Philips is recalling 283 Spectral CT scanners because fasteners that attach the rotor to the gantry bearing may not be properly torqued, potentially allowing rotor parts to become loose or displaced during operation.
F.H. INVESTMENTS, Inc. is recalling Testosterone 100mg/Anastrozole 4mg injectable pellets nationwide due to potential metal particulate matter. Affected lot numbers are 254000105, 254000110, 254000112, and 254000113.
Philips is recalling the Azurion 3 M15 imaging system because the patient table may move unexpectedly when the Reset Geometry button is pressed, even when locked. This poses a patient safety hazard during interventional procedures.
Philips is recalling 52 IQon Spectral CT scanners because fasteners attaching the rotor may not be properly torqued, potentially allowing rotor parts to become displaced or expelled during operation.
A firmware defect in the da Vinci 5 Surgeon Console Viewer Display may cause loss of one or both displays during surgery. When visualization is lost, surgical instruments remain active, risking tissue injury and bleeding.
Philips is recalling 922 Azurion 5 M20 fluoroscopy systems because the patient table may move unexpectedly when the Reset Geometry button is pressed, even when the table lock is active.
Medline Industries is recalling 8,445 medical convenience kits nationwide due to open seals on BD ChloraPrep Triple Swabstick applicator packaging. The defect may compromise product sterility.
Philips Azurion 3 M12 fluoroscopy systems may experience unexpected table movement when the Reset Geometry button is pressed, even when the table lock is active. The recall affects 291 units distributed worldwide.
Philips Azurion 7 B20 fluoroscopy systems may move unexpectedly when the Reset Geometry button is pressed, even with the table lock engaged, creating a potential safety risk during medical procedures.
Medline Industries is recalling Intubation Trays (SKU DYNJAA245B) distributed nationwide and in Canada because smaller 8 Fr suction catheters were packed instead of required 14 Fr catheters, which may cause airway obstruction and respiratory failure.
Laerdal Medical Corporation recalled certain Compact Suction Unit 4 RTCA models because units made during a limited period may emit electromagnetic noise exceeding established RTCA standards.
Medline Industries is recalling 216 medical convenience kits containing BD ChloraPrep Triple Swabsticks due to potential open seals on applicator packaging that may compromise product sterility.
Ventura Foods LLC is recalling Creamy Peanut Butter and Grape Jelly Poco Pac products due to blue plastic pieces found in a filter during production. Products were distributed to 38 states.
Karison brand Besan Laddoo is being recalled because milk is not listed in the ingredient statement. The product is made in a facility that processes milk, posing a risk to consumers with milk allergies.
Carrot Top Kitchens Lemon & Garlic Hummus is recalled due to undeclared sesame. This poses a risk to consumers with sesame allergies. Twelve units were distributed in New York.
F.H. Investments (dba Asteria Health) is recalling Testosterone 25.0 mg sterile pellets nationwide due to the potential presence of metal particulate matter. Affected patients should contact their healthcare provider.
Fresenius Kabi Compounding is recalling vancomycin HCl injectable product due to lack of assurance of sterility. The recall affects 1,578 bags distributed nationwide.
Asteria Health is recalling 1,475 units of Estradiol 20 mg pellets nationwide due to potential metal particulate matter contamination. Patients should contact their healthcare provider.
Fresenius Kabi is recalling 1,410 bags of compounded ketamine injectable due to lack of assurance of sterility. The product was distributed nationwide.
Asteria Health is recalling Estradiol 12.5 mg sterile pellets nationwide due to potential metal particulate matter. The product was distributed throughout the United States.
F.H. Investments is recalling Testosterone 100mg with Triamcinolone Acetonide 20mcg sterile pellets nationwide due to potential metal particulate matter. Affected lot 256000104 expires July 30, 2026.
F.H. Investments (Asteria Health) is recalling testosterone 18.0 mg sterile pellets due to potential metal particulate matter in the product. Patients should contact their healthcare provider.
Asteria Health is recalling Testosterone 100mg/Anastrozole 4mg sterile pellets (NDC 79559-4104-01, Lot 254000104) nationwide due to potential metal particulate matter contamination.
Meitheal Pharmaceuticals is recalling 16,477 Cetrorelix Acetate injection kits due to missing or duplicated needles in the delivery system. Patients may be unable to properly administer the medication.
Fresenius Kabi is recalling vancomycin HCl injections distributed nationwide due to inability to assure product sterility. Two specific lots are affected.