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.
Kyte Baby is recalling about 20,500 Slumber Suits sold from November 2022 to March 2024 because they violate federal flammability regulations for children's sleepwear, posing a risk of burn injuries. No injuries have been reported.
GM is recalling 2022-2023 Chevrolet Express and GMC Savana vehicles for a transmission software defect that may cause rear wheel lockup and unintended vehicle movement. Dealers will update the software free of charge.
Reser's Fine Foods is recalling Bistro 28 Chicken Quesadilla Express Meal Kits distributed across 30 states due to potential Listeria monocytogenes contamination in the cooked chicken.
Sumitomo is recalling specific Falken WildPeak AT4W tires because they may contain incorrect cord material, increasing the risk of tire failure and crashes.
Accord Healthcare is recalling Cinacalcet 30mg tablets nationwide due to a nitrosamine impurity (N-nitroso-cinacalcet) exceeding acceptable daily intake limits. Patients should consult their healthcare provider to confirm if their medication is affected.
Integra LifeSciences is recalling Codman Surgical Patties and Strips because raw material contained higher-than-expected endotoxin levels, potentially affecting finished goods.
Olympus is recalling three Quest Spectrum 3 Fluorescent Imaging Systems in Ohio because they do not meet electromagnetic compatibility standards, which could cause malfunction during procedures.
Reser's Fine Foods recalls Don Pancho Creamy Green Chile Chicken Enchilada Express Meal Kits due to potential Listeria monocytogenes contamination in the cooked chicken. The recall affects 4,179 cases distributed across 30 states.
Reser's Fine Foods is recalling Green Chile Chicken Enchilada Kits due to Listeria monocytogenes contamination in the cooked chicken. Affected products were distributed across 30 U.S. states.
Olympus Corporation recalls 279 units of its ESG-410 electrosurgical generator nationwide due to increased complaints of system error E1226 (Could not write to Audio Buffer) occurring during surgical procedures.
Dr. Reddy's Laboratories recalls Cinacalcet 30 mg tablets nationwide due to manufacturing defects that produced N-nitroso impurity above FDA recommended limits. Patients should contact their healthcare provider if they are taking an affected lot.
Accord Healthcare recalls Cinacalcet 60mg tablets nationwide because N-nitroso-cinacalcet impurity was detected above acceptable daily intake limits. The contamination resulted from manufacturing process deviations.
King Systems Corp. is recalling AMBU King LTSD oropharyngeal airways because they were marketed for pediatric use without FDA clearance for that indication. The device exceeded its 510(k) exemption limitations.
Nihon Kohden America is recalling its Adult/Pediatric Forehead Disposable SpO2 Sensor (Model 809030006) because the device was distributed without FDA market approval or clearance.
The AVOXimeter 1000E blood oximeter (Serial Number 6824) has calibration values that are higher than normal, causing false oxygen level readings. This may lead to patient care mismanagement based on inaccurate data.
Glaser Organic Farms recalls All Raw Vegan Certified Organic Salsa due to potential glass contamination. The product may pose a risk of injury to consumers.
Integra LifeSciences Corp. is recalling 128 units of Duraform Dural Graft Implant (Model 80-1477US, Lot CT007694) due to endotoxin levels exceeding specifications. No adverse events have been reported.
Abbott is recalling Alinity m STI and HPV test kits due to iron leaching that invalidates quality control checks, potentially compromising test result reliability.
Dr. Reddy's Laboratories is recalling Cinacalcet 90 mg tablets due to N-nitroso impurity exceeding FDA limits. Patients should contact their healthcare provider.
Reser's Fine Foods is recalling Chicken Street Taco Kits due to potential Listeria monocytogenes contamination in the cooked chicken. The product was distributed across 32 states.
Hillrom Centrella Smart+ hospital beds may fail to send remote alerts through the Rauland Responder 5 Nurse Call System, though local bed alerts still function. This could delay nursing staff notification of patient needs.
Integra LifeSciences is recalling surgical patties and strips due to higher-than-expected endotoxin levels in raw materials. The contamination may have resulted in out-of-specification finished products.
Beckman Coulter is recalling over 465,000 thyroglobulin antibody test kits because their instructions incorrectly state that biotin interference was addressed. The false information could lead to false-low test results.
Smith & Nephew is recalling a knee prosthesis component after discovering some packages contained a different implant than labeled. No illnesses or injuries have been reported.
Integra LifeSciences' surgical patties and strips (Model 801404) are being recalled due to higher-than-expected endotoxin levels that may have resulted in out-of-specification products. No illnesses have been reported.