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.
Teva Pharmaceuticals recalls 7,080 packets of Testosterone Gel nationwide due to higher-than-labeled potency. Patients using the recalled product may receive unintended overdoses.
Fagron Compounding Services is recalling Lidocaine HCl Injection due to lack of assurance of sterility. Four lot numbers distributed nationwide are affected with expiration date 10/14/2024.
FDA recalls 19 units of the IBA Proton Therapy System PROTEUS 235 due to occasional failures in collision detection for the Forte Robotic Patient Positioning System affecting facilities across multiple US states and internationally.
Stryker Sustainability Solutions is recalling disposable 5 lead cable systems that may contain non-approved ECG leads which were improperly reprocessed. The wrong components may cause devices to malfunction.
Alcon Research LLC is recalling ClearCut S Safety Sideport Knife ophthalmic surgical instruments due to reports of decreased sharpness. Affected units may not perform as intended during eye surgery.
Medline Industries recalled 6,998 medical procedure kits worldwide due to slight dimensional variations that may cause difficulty fitting into outer canisters. The Class II recall affects multiple procedure kit types distributed in the US and internationally.
KALO All Natural Chocolate Cake Gluten Free (84 slices) is recalled due to undeclared soy. Carrot cake slices were accidentally packaged in chocolate cake containers.
Medline is recalling 2,588 ENDO KIT medical procedure kits worldwide due to dimensional variation that may cause difficulty fitting into the outer canister.
Alcon is recalling approximately 11,916 ClearCut SB Intrepid 2.2 ANG ophthalmic knives due to complaints about blade sharpness. The affected units were distributed nationwide and internationally.
Medline Industries is recalling approximately 35,900 Med-Soft Liners due to a dimensional variation that could make them difficult to fit into the outer canister. No injuries have been reported.
NeuroLogica has recalled its GM60A Digital Diagnostic Mobile X-Ray System due to potential failure of the anti-fall safety system in the device arm. The recall affects 31 units distributed nationwide.
ROi CPS LLC is recalling 78 Regard Kits containing Microtek decanters due to pin holes and tears in sterile packaging that cannot be identified visually. Defective packaging could compromise the sterile barrier.
Alcon is recalling specific ophthalmic surgical knives due to reported sharpness defects. The recall affects 3,791 units distributed nationwide and internationally.
Alcon is recalling ClearCut and A-OK ophthalmic surgical knives due to sharpness complaints. The defect affects 1,057 units distributed nationwide and internationally.
Alcon is recalling 11,676 ophthalmic surgical knives due to increased reports of sharpness defects. Affected units were distributed nationwide and internationally.
Microtek Medical Inc. is recalling Bag Decanter II medical devices due to pinholes and tears identified in the sterile packaging film during quality testing, which could compromise product sterility.
Alcon is recalling specific ophthalmic surgical knives (ClearCut and A-OK models) from its Custom Pak system due to blade sharpness complaints affecting 384,851 units distributed nationwide and internationally.
Alcon Research LLC recalls ClearCut and A-OK ophthalmic surgical knives due to increased reports of sharpness issues that may affect surgical performance.
EL Chilar-HF, LLC is recalling El Chilar Canela Molida (Ground Cinnamon) due to elevated lead levels detected in samples tested by the Maryland Department of Health. Affected products were distributed in Maryland.
The BD BACTEC MGIT 960 PZA Kit may intermittently produce falsely resistant results when testing TB susceptibility to pyrazinamide. This Class II recall affects 12,383 units distributed worldwide.
Alcon is recalling specific ophthalmic knives following an increase in complaint reports related to sharpness. These surgical instruments are used in eye procedures.
Intrinsic Therapeutics recalls 207 units of Barricaid Annular Closure Impactor devices nationwide due to manufacturing defects where at least two units are missing critical welds.
Alcon is recalling 3,721 units of its 25GA Valved Entry System ophthalmic knives due to complaint reports about sharpness. The devices were distributed nationwide and internationally to 50+ countries.
Alcon is recalling specific ophthalmic knives due to an increase in complaints regarding insufficient sharpness. Affected units may not perform as intended during surgical procedures.
Baxter Spectrum Wireless Battery Modules may fail to automatically transmit infusion status information to hospital electronic medical records systems. The software issue affects 17,377 units nationwide.