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.
Hospira 8.4% Sodium Bicarbonate Injection USP, 50 mEq/50 mL, lot LH2671, is recalled nationwide for lack of assurance of sterility. 15,750 vials are affected.
Raw Ramen Noodle HA #22W in 10 lb bulk cases, made by Kobayashi Noodle USA, is recalled because the label does not declare soy as the source of the lecithin ingredient. 945 cases are affected.
Tavaborole Topical Solution 5%, 10 mL bottles from lot T401968, distributed by Viona Pharmaceuticals, is recalled because of discoloration. 3,960 bottles are affected.
Cipla Albuterol Sulfate Inhalation Aerosol, 90 mcg, lot 4IB0519, is recalled nationwide after out-of-specification particle size distribution results at the 12-month stability point. 20,352 packs are affected.
Dynex Agility Sample Tips, model 67910 lot 863366, are recalled because the internal rack label reads reagent tip rack, causing the instrument to misidentify the tips and preventing their use. 237 units are affected.
Clearview Strep A Exact II Dipstick Respiratory Kits are recalled because a classification error in the inventory system sent devices to customers without the required license to buy them. 5 kits are affected.
DRS Vascular is recalling 264 Q-Stop Suture Retention Devices. The FDA enforcement record for this action carries a placeholder in place of a stated reason for the recall.
VITROS Chemistry Products Ca Slides, catalog number 145 0261, generations 67 and above, are recalled because calibration failures on VITROS XT systems delay calcium test results. 174,215 units are affected.
Sensodyne Pronamel Active Shield toothpaste is recalled for a label mix-up: the outer carton reads Fresh Mint while the tube reads Cool Mint/Whitening. The toothpaste inside is Fresh Mint, as the carton states.
Certain batches of the Carotid WALLSTENT Monorail Endoprosthesis are being removed after complaints of greater than anticipated resistance withdrawing the delivery system. The most serious potential consequence is stroke.
Randalls Mini Salad Croissant 16 Inch Trays are recalled for potential Listeria monocytogenes contamination. The FDA classified the action as Class I, its most serious category.
Baxter is issuing an urgent correction for 36,705 Novum IQ large volume pumps because the pump may underinfuse when moving to a flow rate more than double the current one.
Sysco Imperial Deluxe Tuna Salad in 5 lb foodservice tubs is recalled for potential Listeria monocytogenes contamination traced to recalled Newly Weds Foods breadcrumbs. 70 cases are affected.
Ready Meals Tuna Salad Over Bed of Lettuce is recalled for potential Listeria monocytogenes contamination. The FDA classified the action as Class I, its most serious category.
Ambu is recalling 87,156 SPUR II adult resuscitators because the manometer port may be blocked, leaving the manometer non-functional. The FDA classified the action as Class I.
Randalls Premium Tuna Salad is recalled for potential Listeria monocytogenes contamination. The FDA classified the action as Class I, its most serious category.
Ready Meals Quad Tuna Salad is recalled for potential Listeria monocytogenes contamination. The FDA classified the action as Class I, its most serious category.
Randalls Mini Salad Croissant 18 Inch Trays are recalled for potential Listeria monocytogenes contamination. The FDA classified the action as Class I, its most serious category.
Jewel Osco Club Sandwiches with Salad are recalled for potential Listeria monocytogenes contamination. The FDA classified the action as Class I, its most serious category.
Ready Meals Tuna Salad is recalled for potential Listeria monocytogenes contamination. The FDA classified the action as Class I, its most serious category.
Ready Meals Sustainable Tuna Salad Croissant Sandwich is recalled for potential Listeria monocytogenes contamination. The FDA classified the action as Class I, its most serious category.
Abbott is recalling 53 HeartMate Mobile Power Unit AC power cords, model 107760, because a misaligned V-Lock may not engage and can allow an unintended disconnect. The FDA classified this as Class I.
DreamStation Auto non-continuous ventilators are recalled because the devices may carry a programming error resulting in an incorrect device configuration. The FDA classified the action as Class I.
Reser's Tuna Salad in 5 lb foodservice tubs, the version without pickle relish, is recalled for potential Listeria monocytogenes contamination from recalled breadcrumbs. 173 cases are affected.
Sysco Classic Tuna Salad in 5 lb foodservice tubs is recalled for potential Listeria monocytogenes contamination traced to recalled Newly Weds Foods breadcrumbs. 779 cases are affected.