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.
Piantedosi Baking Co. is recalling Split Top Burger Rolls due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. Affected products were distributed across multiple northeastern and southeastern states.
Select Bakery Gourmet Blueberry Pound Cake (5 oz) is recalled due to undeclared soy and food colorings. The product was distributed in Georgia, North Carolina, and South Carolina.
MERCHSOURCE LLC is recalling a handheld ultraviolet-C germicidal wand (model 1013622) due to excessive ultraviolet-C radiation emission. Consumers should stop using the product immediately.
American Contract Systems recalled 29 hysterectomy and vaginal packs distributed to health systems in 13 states due to exposure to multiple sterilization cycles without validation.
Piantedosi Baking Co. is recalling Slider Rolls No Seeds 24-pack due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. The recall affects 18,119 units distributed across 15 states.
Select Bakery Gourmet Old Fashion Pound Cake (5 oz) is being recalled due to undeclared soy allergen and artificial food dyes (Yellow #5, Yellow #6, Red #40). The product was distributed in Georgia, North Carolina, and South Carolina.
Datascope Corporation recalls certain lots of Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheters due to undersized dilators. The manufacturing defect affects approximately 10,427 units distributed internationally and awaiting U.S. distribution.
The VITROS XT 7600 laboratory analyzer may report inaccurate test results when the system performs a shutdown. The issue affects approximately 1,148 units distributed worldwide.
The VITROS XT 3400 Chemistry System may produce inaccurate test results during shutdown due to electrical current shifts. The FDA has classified this Class II recall, affecting 506 units distributed worldwide.
American Contract Systems is recalling 118 convenience packs of surgical instruments because they were exposed to multiple sterilization cycles without validation of the product's ability to withstand repeated sterilizations.
Select Bakery is recalling Gourmet Lemon Pound Cake due to undeclared soy and artificial color additives (Yellow #6, Red #40). The product was distributed in Georgia, North Carolina, and South Carolina.
American Contract Systems is recalling 24 units of pacemaker and cardiothoracic surgical packs distributed to health systems in multiple US states. Products were exposed to multiple sterilization cycles without proper validation.
BALT USA recalls the Optima Coil System because devices were distributed with material from an alternate supplier before required testing was approved. No illnesses or injuries have been reported.
Piantedosi Baking Co. is recalling Gourmet Junior Burger Roll 12-packs distributed across 15 states due to potential contamination with Cronobacter sakazakii and Clostridium botulinum.
American Contract Systems is recalling 61 angiography and catheterization packs that were exposed to multiple sterilization cycles without proper validation. The affected packs were distributed to healthcare facilities in 13 U.S. states.
American Contract Systems is recalling 39 laparoscopy instrument packs that were exposed to multiple sterilization cycles without validation. The sterilization process was not tested for repeated exposures.
American Contract Systems, Inc. is recalling 116 convenience packs distributed to U.S. health systems and distributors in 13 states because they were exposed to multiple sterilization cycles without validation, potentially compromising device sterility assurance.
Medline Industries is recalling Chest Tube Convenience Kits due to non-sterile tape included in the sterile portion of the kit, creating a contamination and infection risk.
Piantedosi Baking Co. is recalling Hawaiian Sandwich Rolls due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. Affected products were distributed across multiple states.
American Contract Systems is recalling Cysto Packs distributed to health systems and distributors because the devices were exposed to multiple sterilization cycles without validation for multiple exposures.
Piantedosi Baking Co., Inc. is recalling Gourmet Potato Deli Rolls due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. Approximately 18,119 frozen trays were distributed to consumers.
Plastikon Healthcare LLC is recalling 502,600 cups of Milk of Magnesia USP due to manufacturing process control deviations. Consumers should discontinue use and consult their healthcare provider if concerned.
Select Bakery's 3-oz Orange Creme Cake is recalled for undeclared soy. The product was voluntarily recalled and distributed to Georgia, North Carolina, and South Carolina.
Plastikon Healthcare LLC is recalling an antacid oral suspension due to manufacturing control deviations. No illnesses have been reported.
Plastikon Healthcare LLC is recalling Milk of Magnesia USP due to manufacturing process control deviations affecting approximately 92,200 cups distributed nationwide.