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.
Baxter is recalling 22,392 units of MiniCap Extended Life PD Transfer Sets (Part Number 5C4482EJ) due to reports of female connector separation. Affected units were distributed worldwide.
Treehouse Foods is recalling Krusteaz brand griddle waffles due to potential Listeria monocytogenes contamination. Products were distributed nationwide in the USA and Canada.
Philips is recalling 5,231 units of the Mammotrak Interventional Coil 1.5T nationwide due to a potential safety issue that may harm patients during MRI preparation or scanning.
Baxter Healthcare is recalling MiniCap Extended Life PD Transfer Sets due to increasing reports of the female connector separating from the main body. The defect affects 62,718 units distributed worldwide.
Treehouse Foods recalls Kodiak Cakes 8/9.88oz Mini Griddle Waffles sold nationwide due to potential Listeria monocytogenes contamination. Affected products have batch codes starting with 2C and Best By dates from October 1, 2024 through October 11, 2025.
Philips dS Breast 16ch 3.0T MRI systems are being recalled due to a potential safety issue that could harm patients during medical scans. The FDA-mandated Class II recall affects 5,231 units distributed nationwide.
Hannaford brand seafood salad is recalled because it contains undeclared hydrolyzed soy protein. Consumers with soy allergies should be aware of this risk.
Treehouse Foods recalls KRUSTEAZ and GOOD & GATHER griddle waffles due to potential Listeria monocytogenes contamination. Affected products have batch codes starting with 2C and best-by dates from October 1, 2024 through October 11, 2025.
Philips is recalling 5,231 units of the ST SENSE Breast Dx Coil nationwide due to a potential safety issue that may harm patients during breast imaging scans. No injuries have been reported.
Philips North America is recalling approximately 5,231 dS Breast 16ch 1.5T MRI systems nationwide due to a potential safety issue that could harm patients during scan preparation or procedures.
Baxter is recalling 83,448 units of MiniCap Extended Life PD Transfer Sets due to reports of female connector separation from the device body.
Philips is recalling 5,231 Mammotrak Diagnostic Coil 1.5T units nationwide because of a potential patient safety issue during MRI scans. The FDA has classified this as a Class II recall.
MEDLINE procedure kits are being recalled because connectors may not allow proper catheter insertion if not fully opened. The recall affects 3006 units distributed in the US and internationally.
Nature's Path Organic 12-pack griddle waffles with batch codes starting 2C and best-by dates between October 2024 and October 2025 are recalled due to potential Listeria monocytogenes contamination. No illnesses reported.
Micro-X Ltd. is recalling 6 units of the MICRO-X Rover Mobile X-ray System due to environmental operating risks. The system requires strict temperature, humidity, and altitude controls to prevent capacitor malfunction, overheating, and unintended start-up.
SE Grocers and Pics by Price Chopper brand griddle pancakes are being recalled by Treehouse Foods due to potential Listeria monocytogenes contamination. Affected products were distributed nationwide in the USA and Canada.
Treehouse Foods is recalling Signature Select Griddle Pancake Mini packages due to potential Listeria monocytogenes contamination. The recall involves 9,907,389 cases distributed across the United States and Canada.
Treehouse Foods is recalling Nature's Path Organic griddle waffles due to potential Listeria monocytogenes contamination. The affected products were distributed nationwide in the United States and Canada.
Treehouse Foods is recalling approximately 9.9 million cases of organic griddle waffles from multiple brands due to potential Listeria monocytogenes contamination. Consumers should not consume the affected products.
Shimadzu laboratory autosamplers are being recalled due to water intrusion from a dehumidifier that can cause electrical short circuits. Affected units are distributed worldwide, including across the United States.
Baxter Healthcare is recalling MiniCap Extended Life PD Transfer Sets due to an increase in complaints of female connector separation from the transfer set body. Peritoneal dialysis patients should contact their healthcare provider.
Pero Family Farms Squash Sliced Zucchini & Yellow Squash is being recalled due to potential Listeria monocytogenes contamination. Consumers should not consume the product and should discard it or return it to the point of purchase.
Baxter Healthcare is recalling the MiniCap Extended Life PD Transfer Set due to reports of the female connector separating from the transfer set body. The defect may compromise dialysis treatment safety.
Treehouse Foods is recalling certain griddle waffle products due to potential Listeria monocytogenes contamination. Affected products were distributed nationwide in the USA and Canada.
Treehouse Foods is recalling Kodiak Cakes griddle waffles nationwide due to potential Listeria monocytogenes contamination in batch codes starting with 2C.