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.
Bayer Healthcare Pharmaceuticals is recalling Lotrimin Daily Prevention Deo (Tolnaftate) spray due to potential benzene contamination from manufacturing facility cGMP deviations. The product was distributed nationwide and internationally.
Cordis Corporation is recalling 4 units of the SMART FLEX 10x100 BIL biliary stent system (Lot No. 271626) due to a potential for distal tip dislodgement or separation. The affected units were distributed in the US and Canada.
CooperSurgical Quantum 2000 Electrosurgical Generators may fail to coagulate tissue when using the hand switch during surgery, potentially extending procedures and requiring medical intervention to control intraoperative bleeding. The Class II recall affects 193 units.
Bayer Healthcare is recalling Tinactin (Tolnaftate 1%) liquid spray due to potential benzene contamination. The product was manufactured at a facility where other lots were found to be contaminated with benzene.
ROi CPS LLC is recalling 126 REGARD Basic Cataract trays because a Povidone-Iodine swabstick component is out of specifications. Affected trays were distributed in Florida, Louisiana, and Missouri.
Carolina Ingredients is recalling Jalapeno Seasoning due to possible lead contamination. The product was distributed to a customer in Georgia.
Smith & Nephew is recalling 224 units of EVOS Self-Tapping Locking Screws because package labels were switched, creating a risk that incorrect screw sizes could be implanted during surgery.
ROi CPS LLC has recalled REGARD Ultrasound Trays because they contain out-of-specification Povidone-Iodine swabstick components. The 240 affected trays were distributed in Florida, Louisiana, and Missouri.
Carolina Ingredients is recalling its Smoked Peppered Bacon Seasoning due to possible lead contamination. The product was shipped to a customer in Georgia.
Carolina Ingredients is recalling its Avocado Lime Seasoning due to possible lead contamination. The firm was notified by a customer and sent samples to a lab for testing.
Cordis Corporation is recalling SMART FLEX biliary stent systems due to a potential risk that the distal tip may dislodge or separate, which could compromise the stent's function.
ROi CPS LLC recalled 1,200 REGARD Core Biopsy Trays distributed nationwide because a Povidone-Iodine swabstick component supplied by PDI, Inc. was manufactured out of specifications.
Roche Diagnostics is recalling the Cobas u 601 urinalysis test system due to potential false negative nitrite results when endogenous creatinine levels exceed 15,000 mg/L. The device may fail to detect nitrite in urine samples with elevated creatinine.
Cook Inc. is recalling transseptal needles that may contain rust on internal or external surfaces. If used, the rust could cause increased procedural time or inflammatory reactions, potentially leading to systemic complications.
Laboratoires Bodycad is recalling its Torque Limiting Adaptor AO Connect due to risk of breakage if used counterclockwise and lack of validation for power tool use. Approximately 10 units were distributed to facilities in Colorado, Michigan, and New York.
BioMerieux is recalling 1,382 API 50 CH diagnostic test kits because they may provide incorrect organism identification results, potentially leading to misdiagnosis.
Seneca Foods Corporation is recalling Aunt Nellie's and Happy Harvest sliced pickled beets due to inadequate acidity, which may allow botulism-causing bacteria to grow. The recall affects 15,074 cases distributed across 22 U.S. states.
Cook Inc. is recalling transseptal needles that may contain undetected rust, which could cause inflammatory reactions, systemic responses, and potentially permanent impairment.
OmniLife Science is recalling 7 units of the OMNI K2 Hip Stem due to missing grit blasting on the proximal surface, a defect that could lead to implant loosening and revision surgery. The recall affects units distributed to Colorado and Virginia.
CooperSurgical's LEEP PRECISION System may fail to coagulate tissue when using the hand switch, potentially requiring medical intervention to control intraoperative bleeding during procedures.
Bayer Healthcare is recalling Lotrimin AF Miconazole nitrate 2% Liquid Spray nationwide due to potential benzene contamination. The product was manufactured at a facility where other lots were found to contain benzene.
Bayer Healthcare Pharmaceuticals is recalling Lotrimin AF (Tolnaftate 1%) Daily Prevention deodorant powder spray due to potential benzene contamination. The product was manufactured at a facility where other lots were found contaminated with benzene.
Beaver Visitec International recalls CustomEyes Cataract Surgical Kits containing Xstar Crescent Knives with incorrect blade orientation. Kits labeled as 55-degree bevel-down blades actually contain bevel-up blades.
Cordis Corporation is recalling 3 units of SMART FLEX 6x120 BIL biliary stents due to a potential for distal tip dislodgement or separation. No illnesses or injuries have been reported.
ROi CPS LLC is recalling the REGARD Ear Tray because it contains a Povidone-Iodine swabstick component that does not meet specifications. The product was distributed in Florida, Louisiana, and Missouri.