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.
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.
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.
ROi CPS LLC recalls sterile surgical C-section kits due to light handle covers that may separate and fall during use. The recall affects 1,312 kits distributed in Florida and Missouri.
Biopsy forceps may become unable to open when the endoscope shaft is bent approximately 90 degrees. Additional bending of the forceps shaft can prevent opening entirely.
Draeger Infinity M300/M300+ patient monitoring systems may display or print ECG waveforms with inaccurate QRS amplitudes due to software peaks being dropped on narrow waveforms.
Mani Trocar Kits (Models MTK23S and MTK25S) are being recalled due to a packaging defect that may compromise the sterile barrier. The recall affects 45 kits distributed to one consignee in Missouri.
Carefusion recalled 726 units of two vaginal specula models with labels and laser etchings switched during packaging. This mislabeling could result in use of an unintended product.
Sun Pharmaceutical is recalling 24,194 prefilled syringes of Fyremadel (ganirelix acetate) injection due to glass contamination found in a unit from lot HAD1190A. The recall affects units distributed nationwide with expiration 02/2024.
ROi CPS LLC is recalling 662 sterile surgical convenience kits because light handle covers may separate from the light handle and fall off during use. The kits were distributed in Florida and Missouri.
Draeger Infinity CentralStation patient monitors may display ECG waveform amplitudes lower than actual values due to a software bug affecting versions VG2.1.3 and lower.
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.
Surgical grasping forceps may fail to open when the endoscope shaft is bent, potentially affecting their use during endoscopic procedures.
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.
Northwind Pharmaceuticals is recalling 33 bottles of Doxazosin 4mg tablets due to manufacturing quality control deviations. No illnesses or injuries have been reported.
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.
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.
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.
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.
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.
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 recalls VersaOne Reusable Positioning Cannula due to manufacturing defect that may leave a metal burr inside the device. No injuries reported.
FUJIFILM's FDR AQRO digital X-ray system arm may break during use. The tube head support is susceptible to failure, which could cause serious harm to patients or operators.