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.
ROi CPS LLC is recalling 386 sterile surgical convenience kits (WPH GYN Laparoscopy Pack) because light handle covers may separate and fall off during use.
Paximadi Co LLC is recalling Baklava manufactured on 3/29/2023 for undeclared soybean oil. Consumers with soybean allergies should not consume the product.
ROi CPS LLC is recalling sterile surgical convenience kits because light handle covers may separate and fall off during use. The affected kits were distributed in Florida and Missouri.
Richard Wolf surgical forceps may fail to open when used during endoscopic procedures if the endoscope shaft becomes bent. Approximately 838 units are affected worldwide.
Rajbhog Sweets Yellow Jalebi is recalled because the product label lists butter but does not include the common allergen name 'milk.' Milk-allergic consumers face risk if they consume this product.
Surgical grasping forceps may fail to open when the endoscope shaft is bent, potentially affecting their use during endoscopic procedures.
Siemens recalls the ARTIS one angiography system due to a hybrid cable display issue that may prevent image function on examination room monitors. Four US units are affected.
Baxter Healthcare is recalling Dianeal Low Calcium peritoneal dialysis solution nationwide due to potential leaks from the container that could compromise sterility. Affected patients should contact their healthcare provider.
ROi CPS LLC is recalling sterile surgical convenience kits because light handle covers may separate and fall off during use. The recall affects 278 kits distributed in Florida and Missouri.
SPINEART's JULIET Ti LL lateral lumbar implant plates may disassemble during preparation or implant removal, causing surgical delays. The FDA is recalling 544 affected units distributed across eight US states.
Dole Fresh Vegetables Inc is recalling Dole Chopped Kit Teriyaki Pineapple salads due to undeclared milk allergen. The product was distributed in Florida, Pennsylvania, Virginia, Tennessee, and Louisiana.
Wismettac Asian Foods recalls Shirakiku Brand Japanese Style Noodle Sanuki Udon due to undeclared fish allergen. The product was distributed in California, Colorado, Georgia, and Arizona.
Covidien LP is recalling VersaOne Reusable Positioning Cannulas (Model RC12STS) due to manufacturing defects that may produce metal burrs on the inside of the device, potentially causing internal tissue damage during use.
Northwind Pharmaceuticals is recalling 33 bottles of Doxazosin 4mg tablets due to manufacturing quality control deviations. No illnesses or injuries have been reported.
ROi CPS LLC is recalling sterile surgical convenience kits because light handle covers may separate and fall off during use. Approximately 70 kits were distributed in Florida and Missouri.
ROi CPS LLC is recalling 1,369 sterile surgical convenience kits because light handle covers may separate and fall off during use. The affected kits were distributed nationwide in Florida and Missouri.
The HAMILTON-C6 ventilator (103 units) has a software error that disables patient input monitoring when switching to adaptive ventilation modes with a connected controller or humidifier. The device will alarm but cannot respond to patient inputs.
Creekside Mallow Chocolate Chip Mint Marshmallows are recalled due to butterfat in the chocolate chips not being accompanied by a milk declaration in the Contains statement. The product affects 2,800 packages distributed in Washington and poses a risk to consumers with milk allergies.
A sterile surgical convenience kit for cardiac catheterization is being recalled because light handle covers may separate and fall off during use. The affected lot includes 322 kits distributed to Florida and Missouri.
Con Amore, Inc. is recalling Cookies con Amore Spring Assortment handmade Italian cookies because the product contains undeclared tree nuts (almonds), posing a serious risk to consumers with nut allergies.
Aesculap Implant Systems recalls Caspar Cervical Retractor (CCR) Basket lids with incorrect GTIN labeling. The product bears GTIN #04046955299592 instead of the correct #04046955299607.
Northwind Pharmaceuticals recalls specific lots of Glimepiride 4mg tablets due to manufacturing practice deviations. Affected tablets were distributed nationwide.
Northwind Pharmaceuticals voluntarily recalls Tadalafil 20 mg tablets nationwide due to manufacturing practice deviations. No illnesses have been reported.
Methapharm Inc is recalling Pantoprazole Sodium 40 mg injection vials due to a manufacturing procedure deviation. Affected products were inadvertently placed into distribution without proper compliance with approved procedures.
DuPont Nutrition USA is recalling specific batches of Avicel PH-101 NF microcrystalline cellulose due to failed conductivity specifications. The pharmaceutical excipient was distributed in bulk to manufacturers in the USA and multiple international locations.