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.
Europastry USA INC is recalling frozen onion pockets sold under multiple labels because they may contain Salmonella. Consumers should not eat the affected products.
Mountain View Bakery is recalling Apple White Chocolate Bread (4oz and 8oz sizes) sold at Pilot gas stations in Tennessee because the product contains undeclared milk, a common allergen.
FujiFilm Healthcare is recalling Arietta 750 Ultrasound Software versions V1.0.0 through V2.1.3 due to measurement display errors in critical cardiology functions that could lead to incorrect clinical diagnoses. The instruction manual also contains an error.
Arietta 65 Ultrasound systems with software versions 1.0 through 4.0.0 contain a calculation error that produces incorrect measurements of cardiac valve function during diagnostic assessments.
Karl Storz FIVE S 3.5x65 flexible intubation videoscopes failed sterility assurance testing. The recall affects 532 units distributed across the US and Canada due to infection risk.
Picket Fence Creamery is recalling Jalapeno-Ranch White Cheddar cheese curds (12 oz, UPC 094922414984) distributed to Iowa grocery stores because they contain undeclared soy lecithin, a potential allergen for consumers with soy allergies.
Picket Fence Creamery is recalling maple ice cream sold in Iowa grocery stores because it contains undeclared soy lecithin, which poses a hazard to consumers with soy allergies.
Siemens Healthcare Diagnostics is recalling 261 ADVIA Centaur SARS-CoV-2 Antigen Assay test kits distributed nationwide because the FDA determined that validation data submitted for emergency authorization was insufficient to confirm the assay's effectiveness.
Picket Fence Creamery is recalling CowaBrownie! ice cream in multiple sizes due to undeclared soy lecithin. Consumers with soy allergies should not consume this product.
Mountain View Bakery is recalling Chocolate Cake Rolls (4oz and 8oz) distributed to Pilot gas stations in Tennessee because the product contains undeclared milk, a common allergen.
3M Red Dot ECG monitoring electrodes (Catalog No. 2244) are being recalled due to potential breakage of the carbon stud from the eyelet. Approximately 2,081,000 units distributed nationwide and internationally are affected.
NSE Products, Inc. is recalling Pharmanex Kids Jungamals dietary supplement because the label does not disclose fish allergen present in the product's Vitamin E ingredient.
Kansas City LLC., DBA Best Harvest Bakeries is recalling approximately 10,712 hamburger buns distributed to restaurants across 14 states due to positive environmental samples for Listeria and Salmonella.
Picket Fence Creamery is recalling 12 oz packages of Taco White Cheddar cheese curds due to undeclared wheat and missing gluten-free labeling. The product was distributed to grocery stores in Iowa.
Lupin Pharmaceuticals is recalling Irbesartan 75 mg tablets due to detection of the impurity N-nitrosoirbesartan in the active pharmaceutical ingredient. The recall affects 51,144 bottles distributed nationwide.
GM Helix Acqua Implant dental implants were mislabeled as a smaller size. If incorrectly installed in cases with low bone quality, they could damage the nerve or adjacent bone structures.
Siemens Healthcare's Aptio Automation Interface Module firmware may incorrectly associate test results with the wrong sample IDs, potentially affecting clinical decision-making.
Implant Direct Sybron Manufacturing is recalling 83 dental implants from lot 166300 because the implants differ in size from what is labeled on the packaging. The implants were distributed across multiple US states and Japan.
ABUS is recalling about 790 MountZ youth helmets that do not meet U.S. safety standards for bicycle helmets. The helmets pose a risk of head injury and should be returned for a full refund.
Picket Fence Creamery is recalling Bacon-Ranch White Cheddar cheese curds due to undeclared soy lecithin. The product may pose a risk to consumers with soy allergies.
Picket Fence Creamery is recalling Mocha! ice cream in multiple sizes due to undeclared soy lecithin. Consumers with soy allergies who purchased this product should not consume it.
Picket Fence Creamery is recalling Cow Path ice cream because it contains undeclared peanuts, even though the label only declares nuts in general. Consumers with peanut allergies may be at risk.
Implant Direct is recalling 61 dental implants because the packaged implants are a different size than declared on the labeling. Patients who may have received these implants should contact their healthcare provider.
Bayer Medical Care is recalling 6,950 units of MEDRAD Twist & Go Disposable Syringes due to labeling errors that could cause confusion about syringe compatibility with the MEDRAD Mark 7 Arterion Injection System.
Picket Fence Creamery L.L.C. is recalling Chocolate Malt ice cream in multiple container sizes distributed to Iowa grocery stores due to undeclared soy lecithin, a potential allergen.