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.
Medline Industries is recalling 71 FEMORAL PACK and FEVAR convenience kits because they contain a potentially contaminated component.
Accord Healthcare is voluntarily recalling specific lots of Levothyroxine Sodium 112 mcg tablets because they are subpotent. The recall covers nationwide distribution.
Healthmark Industries is recalling ProChek-II tests because they were manufactured with an expired ingredient, which may cause false negative or positive results.
Medline is recalling 24 convenience kits labeled as MAJOR HEAD AND NECK PPS because they contain a potentially contaminated component.
Midmark is recalling IQecg Digital ECG software due to a communication anomaly that may cause incorrect waveforms and inaccurate heart rate calculations.
Medline Industries is recalling 106 C-section convenience kits distributed nationwide due to potentially contaminated components.
GE Medical Systems is recalling 4 units of Portrait Compute and Core Services V1.2 software due to a defect that may cause loss of patient monitoring and reset alarm settings to factory defaults.
Accord Healthcare is voluntarily recalling specific lots of Levothyroxine Sodium 75 mcg tablets nationwide because they may contain less than the labeled amount of active ingredient.
Accord Healthcare is voluntarily recalling specific lots of Levothyroxine Sodium tablets because they may contain less active ingredient than labeled.
Medline Industries is recalling 2,262 medical convenience kits containing neurosponges due to potential out-of-specification endotoxin levels.
Medline Industries is recalling 663 surgical convenience kits distributed nationwide because they contain a potentially contaminated component.
Canon Medical System, USA, INC. is recalling 10 Alphenix digital radiography systems because fixing screws in the ceiling suspended arm may become loose.
Medline is recalling 974 neurosurgical convenience kits containing neurosponges due to potential out-of-specification endotoxin levels.
Medline Industries is recalling 1,349 gynecologic robotic surgery kits nationwide because they contain a potentially contaminated component.
Healthmark is recalling ProChek protein tests because they were manufactured with an expired ingredient, which may cause false negative or positive results.
Accord Healthcare is recalling specific lots of Levothyroxine Sodium 137 mcg tablets because they may contain less than the labeled amount of active ingredient.
GE Medical Systems is recalling Portrait Core Services Software V1.1 because a software issue may cause loss of patient monitoring and reset alarm settings to factory defaults.
Lidl US Trading is recalling 200 units of Eridanous Greek Style Shortbread Cookies because the labels contain only foreign languages and fail to declare wheat, soy, milk, eggs, and coconut.
IMRIS Imaging Inc is recalling six ORT200 operating room tables because a mechanical failure could cause unintended movement and patient injury.
Hollister is recalling specific lots of Onli hydrophilic urethral intermittent catheters because a manufacturing defect may cause a protrusion that leads to genitourinary trauma or bleeding.
Beak & Skiff Sanitizer Alcohol Antiseptic 80% is being recalled because FDA analysis found acetaldehyde above specification limits in the product. The recall affects bottles distributed in New York and through online sales.
Byron White Formulas is recalling A-L Complex Herbal Supplement because the label does not declare walnuts in English, posing a risk to individuals with nut allergies.
Kettle Cuisine is recalling Marketside Tomato Bisque Soup Kits due to a presumptive positive test for Listeria monocytogenes.
IMRIS Imaging Inc is recalling 13 ORT300 operating room tables because a mechanical failure could cause unintended rotational movement, posing a risk of injury to patients.
GE Medical Systems is recalling 15 units of Portrait Core Services Software V1.0.5 because a software issue may cause loss of patient monitoring and reset alarm settings to factory defaults.