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.
Ciprofloxacin Ophthalmic Solution is being recalled because the cap spike is lodged in the bottle nozzle, preventing patients from accessing the medication. Affected lot 084A067 was distributed nationwide.
A modular hip prosthetic stem (52 units) is being recalled due to an incorrect GTIN barcode on the outer carton label, which displays the code for a different product. No injuries have been reported.
Beckman Coulter recalls certain DxI 9000 immunoassay analyzers due to firmware issues that can cause communication failures, potentially delaying patient result reporting.
Microbiologics Inc is recalling Helix Elite Inactivated SARS-CoV-2 quality control material (Lot HE0065-29) because the A549 human cell target may produce late Ct values, potentially affecting test result validity.
Angiodynamics is recalling 1,800 units of IsoLoc prostate treatment balloons due to incorrect fill volume labeling. The affected devices were distributed nationwide.
ZB Importing LLC recalls Ulker Biskrem Cocoa Biscuits due to undeclared wheat and egg. Consumers with these allergies should not consume the product.
Portex Endotracheal Tubes from Smiths Medical ASD, Inc. may have a smaller diameter than expected, potentially causing inadequate ventilation and patient hypoxia.
Turkana Food Inc. is recalling Aleppo Tahini Sesame Paste because the product tested positive for Salmonella. The recalled product was distributed to 23 states.
Mauna Loa Macadamia Nut Company is recalling Milk Chocolate Covered Macadamias due to undeclared almonds. The product may cause allergic reactions in consumers with almond or tree nut allergies.
ICU Medical recalls Potassium Chloride Injection (lot 1023172) whose overwrap labeled as 10 mEq may contain 20 mEq containers, creating overdose risk. Product distributed nationwide.
CareFusion 213, LLC is recalling ChloraPrep One-Step, a preoperative skin preparation drug, due to non-sterility from a package lidding breach allowing fungal contamination. The recall affects 205,440 applicators distributed nationwide and in Canada.
JE Bakery 2019 LLC is recalling Raisin Bran muffins sold under Cub Foods, Jerrys Foods, and County Market brands due to undeclared walnuts. The product was distributed in Minnesota and Wisconsin.
BD Alaris Systems Manager software may transmit outdated automated programming requests to progressive care units. The FDA has classified this as a Class I recall.
Little Leaf Farms Southwest Salad Kit may contain incorrect dressing with undeclared fish and wheat. The recalled lot was distributed in Massachusetts, New Hampshire, and Connecticut.
BD Care Coordination Engine infusion software may send outdated automated programming requests to care units. Healthcare facilities in affected US states should review their systems.
Medtronic is recalling 316,205 aortic root cannulas due to unexpected loose material in the male luer connector. If not identified before use, this defect could cause stroke; if identified, it may delay surgery.
ICU Medical recalls Potassium Chloride 20 mEq IV injection due to mislabeled overwrap showing 10 mEq instead of the correct strength. The correct dose is printed on the actual container.
The FDA is recalling phenylephrine injection solution due to particulate matter contamination. Three lot numbers distributed nationwide are affected.
Ulker Rulokat Hazelnut Wafers are being recalled due to undeclared egg. The product was distributed to retail stores across Canada and 35 US states.
Breckenridge Pharmaceutical is recalling 11,125 bottles of Duloxetine 20mg capsules nationwide due to N-nitroso-duloxetine impurity above FDA-recommended limits. The impurity was detected during quality control testing.
Chattem Inc. is recalling Unisom SleepMelts diphenhydramine HCl 25 mg tablets nationwide due to a nitrosamine impurity detected above FDA's acceptable daily intake limit. Affected lots expire between May 2025 and April 2026.
Mi Ranchito Foods is recalling Green Chile Bean Burritos because milk is not listed in the ingredient statement, posing a risk for consumers with milk allergies.
Aesculap is recalling 1,147 hemostatic forceps due to clamp breakage risk when used beyond design specifications. Units were distributed nationwide and internationally to healthcare providers.
CardioFocus is recalling 833 units of CardiFocus Heartlight X3 cardiac catheters due to potential damage to the sterile barrier pouch that could compromise product sterility. Affected units were distributed worldwide.
ZOLL is recalling certain Powerheart G5 AED units that may fail their self-test when exposed to extreme temperatures or humidity. The affected devices could fail to function properly in emergencies.