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.
IonoStar Plus dental cement capsules contain an incorrect plunger due to a manufacturing error. The defect prevents proper curing of the cement, making the product unsuitable for use.
Mennel Milling Company is recalling approximately 2.6 million pounds of bagel flour distributed in six states due to potential contamination with metal, wood, gasket material, and sifter balls.
Bestco LLC is recalling Family Wellness Cherry Cough Drops nationwide due to potential glass and silicone particulates found during manufacturing. Consumers should stop use immediately.
The OPTIMIZER model CCM X11 implantable pulse generator may incorrectly detect a charging error and cease delivering cardiac therapy, potentially causing patients to experience heart failure symptoms. A total of 1,469 units are affected.
New World Company is recalling bulk cases of Fortune cookies distributed in California due to undeclared wheat and soy allergens that pose a risk to consumers with these allergies.
FUJIFILM Synapse CV 6 medical imaging software may incorrectly calculate left ventricle mass measurements. If used for diagnosis, this calculation error could lead to patient misdiagnosis and incorrect treatment, potentially causing long-term health consequences.
The framegrabber card in Philips Azurion interventional X-ray systems may fail to display diagnostic images properly, potentially delaying procedures.
Vandevi Compounded Asafoetida spice is recalled due to undeclared wheat. Consumers with wheat allergies should not use this product.
Olympus Corporation of the Americas is recalling ESG PK Cutting Forceps because the jaw may fracture during pre-procedure inspection or during the procedure, posing a potential injury risk.
CABTREO acne medication was stored outside refrigeration requirements. The recalled lot was kept at room temperature instead of required refrigerated conditions.
The disk bay component in certain Philips Azurion x-ray systems may fail, potentially preventing diagnostic imaging and delaying procedures. Affected units have been distributed worldwide.
Baxter Healthcare is recalling 13,000 bags of norepinephrine bitartrate injection due to an overwrap label incorrectly showing 4 mg/250 mL concentration, while the primary bag label correctly shows the actual 8 mg/250 mL strength.
Bestco LLC is recalling Meijer Cherry Cough Drops due to potential glass and silicone particulates found during manufacturing quality control inspections. Consumers should stop using the product immediately.
Henry Schein Inc. and Glove Club HSI Gloves Inc. are recalling 1,099 vials of Adrenalin (Epinephrine) Injection because the expiration date on the repack pouch label is incorrect. The product was distributed nationwide.
Bestco LLC is recalling Equate Cherry Cough Drops nationwide due to potential glass and silicone particulates from manufacturing deviations. Affected products are 30-drop and 160-drop bags expiring December 31, 2026.
Boston Scientific is recalling EndoVive Replacement Button Kits due to sizing mislabeling that could cause undersizing and serious complications including tissue damage and sepsis.
3M recalled 764,580 Specialty Blade Assemblies for surgical clippers due to risk of burns from overheating. The blade can reach temperatures exceeding 77°C if left running improperly.
Abiomed is releasing software Version 8.5 for the Automated Impella Controller to fix an issue in versions 8.4 and 8.4.1 where the device failed to recognize the pump. Approximately 4,463 units were distributed nationwide.
Mennel Milling Company is recalling flour products due to potential contamination with metal, wood, gasket material, and sifter balls. Affected product was distributed in Kentucky, Michigan, New Jersey, New York, Ohio, and Pennsylvania.
Canon Medical's INFX-8000F X-ray system may display abnormal horizontal stripe patterns due to a manufacturing change in the flat panel detector's internal board, potentially preventing exam completion.
Mennel Milling Company recalls Pizza 50/50 Unmalted flour due to potential metal, wood, gasket material, and sifter ball contamination. The affected product was distributed across KY, MI, NJ, NY, and PA.
Country Corner Dairy is recalling Sizzling Colby Cheese due to lack of proper pasteurization. The recalled product was distributed in Maryland and Virginia.
Mennel Milling Company is recalling 2.6 million pounds of bulk AP flour that may contain metal, wood, gasket material, and sifter balls. The flour was distributed in six states and should not be used.
Philips Allura Xper fluoroscopic X-ray systems may experience memory module failures that cause the system to stop functioning and prevent imaging. This malfunction could delay critical medical procedures.
Mennel Milling Company is recalling approximately 2.6 million pounds of ALL PURPOSE EN EZ BL flour due to potential contamination with metal, wood, gasket material, and sifter balls.