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.
NatureMills US Incorporated is recalling Nature Mills Vallarai Rice Mix (200g) because it contains undeclared wheat allergen. The product was distributed throughout the USA via the firm's website.
A software issue in REMISOL Advance may incorrectly process date-of-birth information from laboratory systems, causing incorrect reference range calculations and potentially auto-validating erroneous test result flags. The actual test results are not changed, but their evaluation may be affected.
Terumo Cardiovascular Systems is recalling CDI OneView System BPM Probe units due to thermistor assembly errors that cause inaccurate temperature and blood gas measurements, potentially leading to inappropriate clinical decisions.
NatureMills US Incorporated is recalling Nature Mills Traditional Sambar Powder (200g) due to undeclared sesame and wheat allergens. The product was distributed nationwide via the firm's website.
NatureMills US Incorporated is recalling NatureMills Curry Leaf Rice Mix (200g) because it contains undeclared wheat, which poses a risk to consumers with wheat allergies.
Becton Dickinson is recalling a specific lot of BD Insyte Autoguard BC Winged IV catheters (REF 382633, Lot 4222721) due to reports that the catheter needle may be slow to retract or fail to retract entirely.
NatureMills US Incorporated is recalling NatureMills Moringa Rice Mix (200g) because it contains undeclared wheat allergens. Consumers with wheat allergies should not consume the product.
Encore Medical is recalling Altivate Reverse Torx Peripheral screws because the package labeling lists a different screw size than what is actually included in the package.
NatureMills US Incorporated is recalling Nature Mills Black Kavuni Porridge Mix (200g) because it contains undeclared wheat allergens. Consumers with wheat allergies should not consume this product.
NatureMills US Incorporated is recalling NatureMills Avarampoo Soup (100g) because the product contains wheat that is not declared on the label, posing a risk to consumers with wheat allergies.
GE Healthcare Versana Premier R3 and LOGIQ F R3 ultrasound systems can display previous obstetric patient data in fetal weight measurement reports, potentially leading to incorrect clinical decisions based on inaccurate fetal size and growth calculations.
Becton Dickinson is recalling a specific lot of BD Insyte Autoguard Shielded IV Catheters due to reports that the catheter needle may be slow to retract or fail to retract.
Becton Dickinson is recalling BD Insyte Autoguard Shielded IV Catheters (REF 381423, 22GA X 1.00 IN) due to the possibility that the catheter needle may be slow to retract or fail to retract entirely.
Philips Spectral CT systems with affected software may experience unintended motion of the gantry or table that could lead to contact with operators or patients. Additional software issues may also affect CT performance.
NatureMills US Incorporated is recalling NatureMills Dal Garlic Rice Mix, 200g, because the product contains undeclared milk and wheat allergens that are not listed on the label.
Becton Dickinson is recalling BD Insyte Autoguard BC Pro Winged Shielded IV Catheters (18 GA x 1.16 in, Lot 4208538) due to reports that the catheter needle may be slow to retract or fail to retract completely.
Element 112, LLC is recalling Madeline's Patisserie Chocolate Croissants due to undeclared wheat. Consumers with wheat allergies could be at risk.
Becton Dickinson is recalling BD Insyte Autoguard BC Pro Winged Shielded IV Catheters (REF 382944) due to reports that the catheter needle may retract slowly or fail to retract completely.
Becton Dickinson is recalling BD Insyte Autoguard Winged IV Catheters (Ref. 381533, Lot 4282452) because the catheter needle may be slow to retract or fail to retract entirely.
NatureMills US Incorporated is recalling Nature Mills Moringa Leaf Soup (100g) distributed via its website due to undeclared wheat allergens that may pose a risk to consumers with wheat allergies or sensitivities.
Limacorporate S.p.A is recalling PRIMA 4MM Eccentrical Adaptor with Screw devices because the black laser marking used to identify positioning may be missing. The defect could affect proper device placement during use.
NatureMills US Incorporated is recalling Nature Mills Traditional Rasam Powder (200g) because it contains undeclared sesame and wheat allergens that are not listed on the label.
Firehook of Virginia is recalling Firehook Artisan Baked Crackers Classic Sea Salt because some packages contain Everything Bagel Crackers, which include sesame that is not listed on the label.
Bigfoot Biomedical is recalling Bigfoot Unity Diabetes Management System Pen Caps due to a firmware issue that may cause insulin pens to become unresponsive. People with diabetes may lack information needed to make timely treatment decisions.
Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer C11137 due to calibration issues where curves switch from passed to failed status due to system errors, potentially causing erroneous test results.