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.
ICU Medical is recalling 423 Plum Duo Infusion Systems after one lot of defective primary speakers may fail to produce sound, so the pump may not produce audible alarms or alerts.
Intuitive Surgical is recalling 41,526 da Vinci SP Access Port Kits because the Access Port System tray may develop cracks, potentially resulting in a sterility breach.
Canon Medical Systems is recalling 34 Vantage Galan 3T MRI systems because ice may form in the venting system, and a quench in that condition could rupture the helium vessel.
Gold Star Distribution is recalling Colgate toothpaste in 2.5oz 24-count packs over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its distribution center.
Diagnostica Stago is recalling 438 Asserachrom HPIA kits from one lot because a potential defect can affect every well in an impacted strip and produce negative results.
Alvogen is recalling a lot of Levothyroxine Sodium Tablets, 150mcg, after a pharmacy reported a single bottle containing 88 mcg tablets instead of 150 mcg tablets.
Gold Star Distribution is recalling Lucky Ice Cool Mouthwash over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its distribution center.
Gold Star Distribution is recalling NyQuil Cold and Flu over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its distribution center.
Gold Star Distribution is recalling Liquid DayQuil over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its distribution center.
House Of Flavors is recalling 34,561 units of 2248 Banana Pudding Ice Cream, 3 gallon, over undeclared soy lecithin.
Gold Star Distribution is recalling Liquid NyQuil over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its distribution center.
Gold Star Distribution is recalling TUMS antacid tablets over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its distribution center.
GE HealthCare is recalling 7 units of the SMV DSX New Line nuclear medicine system, because systems moved without adequate detector support may suffer a detector fall.
Evenflo is recalling specific Titan 65 child seats that may lack a tether strap, which could reduce crash protection and increase injury risk.
Vanleigh RV is recalling 2022-2023 Ambition trailers because the ramp door may break away from the frame, increasing injury risk.
Winnebago is recalling certain motorhomes equipped with a ThermaHeat Tank Pad because the water tank heating pad may experience high resistance and fail, increasing the risk of a fire.
Hyundai is recalling certain 2025–2026 Genesis vehicles because a software error may cause the instrument panel display to fail, potentially hiding critical safety information like the speedometer and fuel gauge.
Forest River is recalling 2026 Freelander motorhomes because a solar panel wire may lack over-current protection, increasing fire risk.
Lucid is recalling 2025-2026 Gravity vehicles because the rearview camera may not display in reverse, increasing crash risk.
Forest River Bus is recalling 2025-2026 Trans Tech school buses because modified seating may exceed rear axle weight limits, increasing crash risk.
Lucid is recalling certain 2022-2026 Air vehicles with the AD02 package on software versions 2.8.0 through 2.8.16, because the rearview camera image may not display when the vehicle is in reverse.
About 25,000 Ruahouine Hair Growth Serum bottles are being recalled because the serum contains minoxidil and the packaging is not child-resistant.
About 1,260 Greatale self-feeding pillows are being recalled because they hold a bottle at an unsafe angle and fixed in place, which can lead to aspiration of milk or formula.
About 6,100 Adams RealComfort and StyleWell Adirondack patio chairs are being recalled because the chairs can crack and collapse, posing injury and fall hazards.
About 95 Morgan Lane Asher Pajama Sets, Style 816TR in Petal, are being recalled because they violate the mandatory flammability standards for children's sleepwear.