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.
BritePro Solo Mini Single-Use Fiber Optic Laryngoscope Handles are being recalled because the handles may not illuminate as intended.
BD Alaris Pump Infusion Sets are being recalled because the pump module used with them may perform outside the established ranges for flow rate, bolus accuracy and occlusion alarm timing.
Item #99273 chocolate Tres Leches Cheesecake is being recalled because the pecans used in it have the potential to be contaminated with Salmonella.
BritePro Solo Single-Use Fiber Optic Handles and Blades in Macintosh and Miller sizes are being recalled because the handles may not illuminate as intended.
Item #1071 Italian layer cake is being recalled because the pecans used in it have the potential to be contaminated with Salmonella. The source does not state a quantity.
The Plum Duo Infusion System is being recalled because two sequences of programming events and alarm interactions may cause the user interface to become unresponsive. 4,677 units are affected.
Aral Silver Vobla whole dried salted roach fish is being recalled because of Clostridium botulinum in uneviscerated fish. 23 boxes are affected across sixteen states.
Britepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handles are being recalled because the handles may not illuminate as intended.
Item #99272 Tres Leches Cheesecake is being recalled because the pecans used in it have the potential to be contaminated with Salmonella.
Item #3145 Hummingbird Layer Cake is being recalled because the pecans used in it have the potential to be contaminated with Salmonella.
Microbore Extension Sets with 0.2 Micron Filter are being recalled because the label indicates an air eliminating filter, but the filter fitted is not indicated for air removal. 34,825 US units affected.
Parashore Pear Slices in Juice, 15 oz, are being recalled because the product is contaminated with elevated lead and cadmium. 8,160 units are affected.
BritePro Solo Single-Use Fiber Optic Mini Handles and Blades in Macintosh and Miller sizes are being recalled because the handles may not illuminate as intended.
Item #1312 Carrot layer cake is being recalled because the pecans used in it have the potential to be contaminated with Salmonella.
BD Alaris Pump Module Model 8100 with Guardrails Suite MX software is being recalled because it may perform outside the established ranges for flow rate, bolus accuracy and occlusion alarm timing.
Tirzepatide + Niacinamide 8.8 mg + 1.0 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 139 vials are affected.
Duloxetine Delayed-Release 30 mg capsules packaged by Direct Rx are being recalled because a nitrosamine drug substance related impurity was present above the proposed interim limit. 875 bottles affected.
Queen Bee Gardens Whipped Honey Raspberry in 11 oz jars is being recalled because the product may have small flakes of stainless steel in it. 129 jars are affected.
OH MMB Human Donor Milk is being recalled because of an inaccurate temperature reading from a thermometer on one pasteurization machine. 5,735 units in total are affected.
One-piece Guedel airways, size 3, are being recalled because of potential contamination with small burrs which, if they detach, could be inhaled. 8,640 pieces are affected.
Queen Bee Gardens Whipped Honey Pure in 11 oz jars is being recalled because the product may have small flakes of stainless steel in it. 112 jars are affected.
Tirzepatide + Niacinamide 2.2 mg + 1.0 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 236 vials are affected.
Semaglutide + Cyanocobalamin 2.21 mg + 0.25 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 176 vials are affected.
Pinnacle 3 with TumorLOC Radiation Therapy Planning System software is being recalled because a software issue may provide incorrect dataset calculations when performing the Stopping Power Ratio. 149 serial numbers affected.
Semaglutide + Cyanocobalamin 0.88 mg + 0.25 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 194 vials are affected.