Severity 3 of 5
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.
The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.
Cargill recalls 977,000 pounds of soy flour products labeled gluten-free that may contain gluten above FDA limits. Products were distributed in the US and multiple countries.
Cargill is recalling 36,000 lbs of grain products labeled as gluten-free that may contain gluten above the FDA safety limit. Consumers with celiac disease or gluten sensitivity should not consume affected product code 110026470-02523CHXEA.
Linkbio Corp. is updating labeling and surgical technique training for the LINK SLED Knee System to prevent early aseptic loosening or excessive wear caused by improper implant positioning or inadequate cementing during surgery.
Cargill is recalling PROSANTE soybean flour products that may contain gluten levels exceeding 20 ppm despite gluten-free labeling. Approximately 826,150 pounds were distributed nationwide and internationally.
Pool Forge Dairy is recalling White Cheese Queso Blanco due to possible pathogen contamination from inadequate pasteurization. The product was distributed in New Jersey with sell-by dates from January 7 to March 28, 2023.
Linkbio Corp. is recalling 15 units of the LINK SLED Knee System tibial component for risk of aseptic loosening and wear from improper implant positioning or inadequate cementing technique. Surgical training will be updated.
Linkbio Corp. is issuing updated surgical technique guidance and training for the LINK SLED Knee System tibial component due to risk of early implant loosening or wear from suboptimal positioning or inadequate cementing.
Bakery 37 Inc recalls Blue Moon Bakery Ginger Molasses Breakfast Cookies (3oz) distributed in Oregon due to sesame declared in ingredients but not in the allergen Contains statement. Affected manufacturing dates: January 1 to March 22, 2023.
Beaver Visitec is recalling the CryoTreQ Aa ophthalmic surgical instrument due to risk of sudden disassembly during use. Device disassembly during cryosurgery could cause permanent vision impairment.
PD-Rx Pharmaceuticals is voluntarily recalling 520 bottles of Simvastatin USP 20 mg nationwide due to manufacturing process quality control deviations. No adverse events have been reported.
Linkbio Corp. recalls the LINK SLED Knee Component due to risk of early aseptic loosening and implant wear. The issue stems from suboptimal implant positioning or inadequate cementing technique.
Philips is recalling certain ProxiDiagnost N90 radiography systems due to a cable under the table that may break. A broken cable could prevent users from tilting the table or engaging braking.
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.
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.
Cargill recalls 174,600 lbs of bulk ingredient distributed nationwide and internationally. Products labeled gluten-free contain gluten levels exceeding 20 ppm.
GE Healthcare's Centricity PACS-IW radiological imaging system can mismatch patient information when correcting study details. 17 units distributed worldwide are affected.
Steris surgical light handle covers may detach during use, risking contamination of the sterile field and patient injury. The FDA is recalling approximately 1.4 million affected covers.
Cargill is recalling PROSANTE vegetable protein products labeled gluten-free due to potential gluten contamination exceeding 20 ppm. Consumers should check product codes and discard or return affected items.
Vesmatic Cube 80 laboratory automation system firmware can incorrectly identify patient samples, potentially leading to wrong test results and inappropriate treatment. Affected systems include FlexLab, Accelerator a3600, and Aptio Automation units.
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.
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.
Bakery 37 Inc is recalling Blue Moon Bakery Legendary Breakfast Cookies because they contain undeclared sesame. The cookies were distributed in Oregon and may pose a risk to consumers with sesame allergies.
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.
FDA recalls LINK SLED Knee System tibial components due to risk of aseptic loosening and premature wear. Patients may require revision surgery.