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.
Indian Motorcycle Company is recalling certain 2019-2022 Challenger, FTR 1200, and Pursuit motorcycles due to brake lights that may illuminate unexpectedly without rider input, potentially confusing following drivers and increasing crash risk.
Lovevery is recalling about 47,000 Slide & Seek Ball Runs with wooden knobs because the wooden knob can detach during or after shipping, posing a choking hazard to children. The product was sold online as part of the Babbler Play Kit from June 2023 through November 2023.
Ekouaer girl's nightgowns fail to meet federal flammability standards for children's sleepwear, posing a risk of burn injuries. About 16,800 units sold on Amazon from May 2020 through July 2023 are affected.
SRAM is recalling about 61,300 12-speed shift brake levers because the clamp bolt can come loose, preventing proper braking and posing a crash hazard to riders. No injuries have been reported.
Toyota is recalling certain 2021 Venza Hybrid vehicles due to water intrusion in rear turn signal lights, which can cause electrical short circuits and lighting failure, increasing crash risk.
Certain 2019-2021 Audi vehicles are recalled for rear axle misalignment that may cause premature tire wear and increase crash risk. Dealers will inspect and adjust the alignment at no charge, replacing any worn tires as needed.
Stripe and Stare children's nightgowns violate federal flammability regulations for sleepwear, posing a risk of burn injuries. About 250 units sold online from February 2021 through January 2023.
iFIT is recalling NordicTrack 50-pound iSelect voice-controlled adjustable dumbbells because weight plates can dislodge during use, posing an impact hazard. Eight injuries including contusions and abrasions have been reported.
Snap is recalling about 71,000 rechargeable lithium-ion batteries sold with Pixy Flying Cameras because the battery can overheat and pose a fire hazard. The company has received four reports of battery overheating and bulging, including one minor battery fire and one minor injury.
Flat River Group is recalling about 22,700 NextGen children's bicycles because they do not meet federal safety standards. The bicycles lack required foot brakes, chain guards, or pedal reflectors, posing crash and injury hazards to children.
DiaSorin LIAISON HSV-2 Type Specific IgG test kits are being recalled because specific lots may produce false positive or equivocal results. Affected kits were distributed in the US and Canada.
C.R. Bard is recalling 26,100 nasogastric sump tubes due to user complaints of inadequate suction and reduced drainage. The malfunction could prevent proper stomach decompression.
IntegraDose Compounding Services recalled 281 syringes of Vasopressin 2 Unit/2 mL due to subpotency. The voluntary recall affects Lot #20230921VAS-2 distributed in Minnesota.
DeIorio Foods has recalled frozen pizza dough sheets that may contain conveyor belt pieces. The recall affects products distributed in CA, NC, and PA with best-use dates of 02/16/2024.
Stonewall Kitchen is recalling Vermont Village Unsweetened Apple Sauce (24oz) because the product contains elevated levels of patulin, a mycotoxin. The recall affects 9,027 units distributed across 22 U.S. states.
Sedecal SA is recalling 845 Sedecal X Optima URS diagnostic x-ray systems after parts fell off the equipment, creating a safety risk to patients and users. The affected units were distributed in Alabama, Florida, and North Carolina.
Beckman Coulter is recalling DxU 850m/840m Microscopy Analyzers (254 units) due to potential rust in the cannula component, which may cause erroneous test results. The recall affects units distributed in the US and multiple international locations.
Kent Imaging's Snapshot NIR tissue oxygenation measurement system touchscreens may become unresponsive, preventing users from viewing diagnostic oxygenation images. Fifty-seven units have been distributed across multiple US states and Malaysia.
C.R. Bard is recalling Bard PreVent Anti-Reflux Filters with ENFit connectors due to user reports of inadequate or reduced suction, decompression, and drainage during use.
Sun Pharmaceutical recalls 6,552 bottles of Niacin Extended-Release Tablets (1000mg) nationwide due to microbial contamination in manufacturing equipment. No illnesses have been reported.
Medtronic is recalling Cobalt XT DR MRI implantable cardioverter defibrillators due to a manufacturing defect in the battery testing process. Some batteries may have bypassed required validation.
Lara's Bakery 3 LLC recalls Panque pound cake because the label declares gluten but omits wheat as a major allergen, with potential undeclared sesame, coconut, soy, milk, and eggs. Consumers with allergies should not consume this product.
Lecoq Cuisine Corporation is recalling RTB Mixed Danish Variety pastries due to undeclared soy lecithin. The recall affects 7,620 units distributed across 26 states.
Beckman Coulter is recalling 112 units of iQ200 Series Urine Microscopy Analyzers distributed globally. The cannula in the Flowcell and Rinse Waste Well Assembly may rust, potentially causing erroneous diagnostic results.
BE Pharmaceuticals recalls Fosaprepitant for Injection nationwide due to failed aseptic process validation. The 22,176 vials from lot #13D012AA may lack sterility assurance.