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.
Dole Chopped Kit Avocado Ranch (UPC 71430000915) is being recalled due to potential contamination with Listeria monocytogenes. The FDA Class I recall affects 50,645 cases distributed across the United States and Canada.
Dole Fresh Vegetables is recalling 50,645 cases of Dole Cajun Ranch Chopped Kit UPC 71430002063 due to potential Listeria monocytogenes contamination. The affected product was distributed in 24 U.S. states and Canada.
Thoratec Corp. recalls HeartMate II left ventricular assist system kits due to outflow graft deformation that could obstruct blood flow. The FDA has classified this as a Class I recall affecting 2,240 units distributed worldwide.
Neptune's Fix Tianeptine Elixir, distributed nationwide by Super Chill Products, is recalled because it contains tianeptine, a substance not approved by the FDA for any medical use in the United States. Consumers should not use this product.
Dole Fresh Vegetables Inc is recalling Dole Premium Kit Endless Summer salad kits due to potential Listeria monocytogenes contamination. Affected products have specific production codes dated February 2024.
Reser's Fine Foods is recalling HEB Cilantro Cotija Dressing due to potential Listeria monocytogenes contamination. The dressing was distributed across multiple states in approximately 5,589 cases.
The FDA is recalling the HeartMate 3 Left Ventricular Assist System due to observed outflow graft deformation that can obstruct blood flow. Patients with implanted devices should contact their healthcare provider.
Wesco Central Commissary is recalling Wesco mint no-bake cookie bites because they contain undeclared peanut and soy allergens that are not listed on the label. The affected product was distributed in Michigan.
Reser's Fine Foods is recalling Cilantro Lime Crema products sold under Costco and Don Pancho labels due to Listeria monocytogenes contamination. Products were distributed across 16 states.
Dole Fresh Vegetables Inc is recalling Marketside Chopped Salad Kit Bacon Crunch due to potential Listeria monocytogenes contamination. Affected packages have lot codes B020-B036 with production dates from February 5, 2024 through February 21, 2024.
ARROW International is recalling 1,160,470 QuickFlash radial artery catheterization devices due to a defective guidewire handle that can cause arterial vasospasm and vessel injury.
Fresh & Ready Foods LLC recalls Jack & Olive Ham Torta Sandwich due to Listeria monocytogenes contamination. The product was distributed in California, Nevada, Utah, and Arizona with use-by dates from January 27, 2024 to February 15, 2024.
Sprig & Sprout Ham Torta Sandwich is being recalled due to potential Listeria monocytogenes contamination. The product was distributed to CA, NV, UT, and AZ with Use By dates from January 27 to February 15, 2024.
Dole Premium Kit Southwest Salad is being recalled due to potential Listeria monocytogenes contamination. Consumers who purchased affected products should not consume them.
Smiths Medical is recalling paraPAC plus 310 ventilators that may malfunction by delivering continuous gas flow instead of cycling breaths. The defect affects 10,140 units distributed worldwide and prevents proper ventilation.
Reser's Fine Foods is recalling multiple chicken taco kits distributed across 16 states due to potential Listeria monocytogenes contamination in a repackaged cheese ingredient. Consumers should not consume affected products.
Smiths Medical Pneupac Plus 300 ventilators may intermittently deliver continuous airflow instead of cycling breaths as designed. This malfunction affects 2,902 units distributed worldwide.
In2Bones, SAS is recalling I.B.S Compression screws due to a batch mix-up. Affected screws may have different lengths than indicated on their labels, creating a risk of improper surgical implantation.
Angiodynamics vascular guidewire introducers (600 units) may have internal defects preventing proper function during surgery. Defects could cause procedure delays and require device exchange.
Angiodynamics recalls MINI STICK MAX vascular guidewire introducers due to internal lumen defects that may prevent the guidewire from passing through during surgery, potentially requiring device exchange.
Novitium Pharma LLC recalls Digoxin 125mcg tablets nationwide due to cross contamination with mycophenolate mofetil, a different medication. Patients receiving contaminated tablets could experience unintended drug effects.
Bob Evans Original Mashed Potatoes (2 lbs) with UPC 75900005349 from batch KCL1 are being recalled due to potential red plastic contamination. No illnesses have been reported.
A Class II medical device recall has been issued for Directional Laser Probes due to potential difficulties extending, retracting, and directing the laser fiber tip. The issue affects 126 units distributed across multiple US states.
D.O.R.C. recalls 78 directional laser probes with Alcon/Lumenis connectors due to difficulties extending, retracting, or directing the laser fiber. The Class II recall affects units distributed across multiple U.S. states and Puerto Rico.
Beckman Coulter recalls Access Total T4 thyroxine assay due to imprecision that may cause erroneous or delayed diagnostic results.