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.
Loard's Strawberry Ice Cream in 32 oz and 56 oz tubs is being recalled because milk and Red #40 are undeclared on the label.
Medline Industries is recalling three models of medical trays due to calibration issues with sterilization equipment that may affect sterility assurance. The recall affects LVAD Driveline Trays and Central Line Dressing Change Trays distributed nationwide.
Loard's Pecan Praline Ice Cream in 32 oz tubs is being recalled because milk and pecans are undeclared on the label. 875 units are affected.
Medline Industries is recalling multiple Convenience Kit medical devices due to calibration issues in sterilization and packaging equipment that may affect sterility assurance. The devices were distributed nationwide.
Woodstock Organic Shelled Edamame in 10 oz and 48 oz bags is being recalled because the product may contain metal pieces. 7,160 cases are affected.
Publix Bran Flakes Wheat Cereal in 18 oz boxes is being recalled because of foreign material, specifically plastic. 13,824 units are affected.
Medline Industries is recalling 26 models of medical convenience kits used in clinical settings because equipment calibration issues may have compromised sterility assurance during sterilization and packaging.
Medline Industries is recalling multiple convenience kits used in surgical and biopsy procedures due to calibration issues with sterilization equipment that may affect sterility assurance. The recall affects 4,064 units distributed nationwide.
Medline Industries is recalling Triple Lumen Insertion Kits (Model DYNDM1031A) due to calibration issues with sterilization equipment that may have compromised the sterility assurance level of the products.
Medline is recalling three models of medical convenience kits (central line, LVAD driveline, and surgical oncology) distributed nationwide due to calibration issues in sterilization equipment that may have reduced sterility assurance.
Chocolate Showers Ice Cream, sold under five store labels, is being recalled because soy is undeclared on the label. 1,396 units are affected.
Loard's Chocolate Mint Ice Cream in 32 oz and 56 oz tubs is being recalled because milk, soy, Yellow #5 and Blue #1 are undeclared on the label.
Medline is recalling Convenience Kits (PPE Kit, Model DYK1011945P) due to calibration issues with sterilization and packaging equipment that may compromise sterility assurance. The product was distributed nationwide.
Medline Industries is recalling over 7,700 surgical convenience kits due to calibration issues with sterilization and packaging equipment that may affect the sterility assurance level of the products.
Medline Industries is recalling 114,778 surgical convenience kits due to calibration issues with sterilization equipment that may affect the sterility assurance level of the products. No illnesses or injuries have been reported.
BioFire Diagnostics, LLC is recalling the Spotfire Respiratory/Sore Throat Panel due to false negative test results and control failures that may not accurately detect infections.
Loard's Black Raspberry Ice Cream in 32 oz tubs is being recalled because milk, Red #40 and Blue #1 are undeclared on the label. 446 units are affected.
Loard's Mango Ice Cream in 32 oz and 56 oz tubs is being recalled because milk and Yellow #5 are undeclared on the label.
Loard's Black Raspberry Marble Ice Cream in 32 oz tubs is being recalled because milk, Red #40 and Blue #1 are undeclared on the label. 362 units are affected.
Centinel Spine is recalling Prodisc C SK U.S. cervical disc implants due to a labeling mix-up: 6mm products were labeled as 5mm and 5mm products were labeled as 6mm, creating risk of implanting the wrong size.
Loard's Lime Sherbert in 32 oz tubs is being recalled because milk, wheat, soy, Yellow #5 and Green #3 are undeclared on the label. 110 units are affected.
Loard's Blueberry Cheesecake Ice Cream in 32 oz tubs is being recalled because milk, Red #40 and Blue #1 are undeclared on the label. 200 units are affected.
Loard's Butterscotch Marble Ice Cream in 32 oz tubs is being recalled because milk is undeclared on the label. 422 units are affected.
Darkside of the Hive creamed and whipped honey products are being recalled because they may contain stainless steel dust or flakes and small particles or shreds of plastic.
Loard's Lemon Chiffon Ice Cream in 32 oz tubs is being recalled because milk, eggs and Yellow #5 are undeclared on the label. 1,048 units are affected.