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.
Cargill is recalling PROSANTE soy flour bearing a gluten-free claim because the products may contain gluten at levels above 20 ppm.
Inpeco laboratory automation systems have a firmware defect that may cause sample ID mis-association, leading to incorrect test results for electrolyte measurements. Potential consequences include abnormal treatment decisions and serious health complications.
Simply Good Foods Co. is recalling Atkins Dark Chocolate Royale Protein Rich Shakes due to contamination that rendered the product non-sterile, creating potential for spoilage.
Linkbio Corp. is updating surgical technique guidance for the LINK SLED knee implant system to prevent early aseptic loosening or implant wear caused by suboptimal positioning or cementing technique during surgery.
Linkbio Corp. is recalling 13 units of the LINK SLED Knee System tibial component due to risk of aseptic loosening and increased wear. These risks arise from improper surgical positioning or inadequate cementing technique during implantation.
The LINK SLED Knee System ALL POLY TIBIAL COMPONENT (18 units) is recalled due to early aseptic loosening and increased wear caused by suboptimal positioning or inadequate cementing technique, which may require earlier-than-expected revision surgery.
Cargill is recalling multiple PROLIA soy flour products that carry gluten-free claims but may contain gluten above 20 ppm. Consumers with celiac disease or gluten sensitivity should not consume affected products.
Siemens ARTIS pheno angiography systems may misposition the C-arm by 5-10 millimeters when using the reference image positioning function, risking patient and staff crushing injuries. The device may also display inaccurate imaging overlays, potentially causing vessel perforation.
Linkbio Corp. is recalling 14 units of LINK SLED Knee System knee implant components due to risk of early loosening and wear caused by suboptimal implant positioning or inadequate cementing technique. Affected patients should contact their surgeon.
Linkbio Corp. is recalling LINK SLED Knee System tibial components due to risk of early aseptic loosening or premature wear caused by suboptimal implant positioning or inadequate cementing during surgery. The manufacturer is updating surgical technique guidance and training.
Labories Medical Technologies is recalling injeTAK Adjustable Tip Needles because packaging damage may compromise the sterile barrier, creating a risk of contamination.
Cargill is recalling PROSANTE vegetable protein bags labeled as gluten-free because they may contain gluten levels exceeding 20 ppm. Consumers with celiac disease or gluten sensitivity should not consume the affected product.
Weleda Inc is recalling Hepatodoron® tablets due to potential metal contamination. The affected batch (J033, expiring January 31, 2027) was distributed nationwide.
Linkbio Corp. recalls LINK SLED Knee System tibial component due to risk of early aseptic loosening caused by inadequate surgical technique. Training on improved surgical technique is being provided.
Cargill is recalling PROSANTE TSOYFLR flour products nationwide and internationally due to potential gluten contamination in products labeled as gluten-free. The recalled products may contain gluten levels above 20 ppm.
Cargill is recalling PROSANTE products labeled as gluten-free that may contain gluten above safe levels (above 20 ppm). Consumers following a gluten-free diet should discontinue use of affected products.
Spacelabs Healthcare is recalling 1,088 Ultraview SL Command Module units due to a software defect. The devices may fail to display alarms or waveforms when parameter processing is suspended, potentially causing clinicians to miss critical patient events.
Cargill is recalling PROSANTE TSOYFLR flour products labeled gluten-free because they may contain gluten above 20 ppm. Consumers with celiac disease or gluten sensitivity should not consume these products.
Cargill is recalling PROSANTE soy flour products labeled gluten-free because they may contain gluten levels above 20 ppm, the FDA's regulatory threshold for gluten-free labeling. Products were distributed nationwide and internationally.
Linkbio Corp. recalls LINK SLED Knee System implants due to risk of early loosening and increased wear caused by improper surgical technique. Updated training and labeling have been issued.
Blue Moon Bakery Choconut Breakfast Cookie is being recalled because sesame is not listed in the Contains statement on the label, despite being present in the product. Consumers allergic to sesame may consume the product unknowingly.
GE Healthcare's Centricity PACS-IW radiological imaging system can mismatch patient information when correcting study details. 17 units distributed worldwide are affected.
Cargill is recalling PROSANTE soyflour products labeled gluten-free because they may contain gluten levels above 20 ppm, the FDA's threshold for gluten-free claims. People with celiac disease or gluten sensitivity should not consume these products.
Linkbio Corp. is recalling LINK SLED Knee System tibial components due to risk of early loosening or increased wear caused by suboptimal implant positioning or inadequate cementing technique. Surgeons are being directed to update their technique and receive additional training.
ASO LLC is recalling Walgreens assorted bandages (item 196568) distributed nationwide due to benzalkonium chloride in the adhesive pad that is not disclosed on the labeling.