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.
Smith & Nephew is recalling TWINFIX ULTRA absorbable suture anchors because improper or incomplete packaging seals may breach the sterile barrier.
ICU Medical is recalling specific lots of intravascular administration sets because a manufacturing defect may prevent the NanoClave from sealing properly.
ICU Medical is recalling specific lots of NanoClave administration sets because a manufacturing defect may prevent a proper seal.
ICU Medical is recalling specific lots of NanoClave Stopcock Manifolds due to a potential manufacturing defect on the internal surface that may inhibit a proper seal with the NanoClave spike.
ICU Medical is recalling specific lots of 128-inch primary sets because a manufacturing defect may prevent the NanoClave spike from sealing properly.
ICU Medical is recalling specific lots of 139-inch intravascular administration sets because a manufacturing defect may prevent the NanoClave spike from sealing properly.
Leather on Wheels is recalling Polo model helmets because they may not adequately reduce impact force, increasing the risk of injury in a crash.
Winnebago is recalling 2012-2021 Era 170X vehicles because a weld nut was installed on the wrong side of the seat belt bracket, reducing retention strength.
Audi is recalling 2018-2020 Q7 vehicles because the C-pillar padding may not absorb enough impact in a crash, increasing injury risk for unbelted occupants.
Forest River is recalling 2021 Cardinal fifth-wheel trailers. The furnace intake sleeve is too short and does not properly connect to the exterior, allowing furnace exhaust to enter the trailer and cause carbon monoxide poisoning.
Forest River is recalling 2019-2021 Palomino trailers because the antenna wing may not be properly secured, allowing it to detach while moving and create a road hazard.
Forest River is recalling 2019-2021 Cherokee recreational trailers due to inadequate wiring insulation on shore cord inlets, which can increase fire risk. Owners should contact Forest River for recall details.
Rocky Mountain Oils is recalling Wintergreen essential oil and four oil blends because the packaging is not child-resistant, posing a risk of poisoning to young children.
Bed Bath & Beyond is recalling SALT Lounge Chairs because the frame's locking mechanism can disengage, posing a fall hazard.
Lucky Spoon Bakery is recalling gluten-free zucchini cupcakes because a flour batch tested positive for gluten. The products were distributed in eight states and nationwide via drop ship.
Gentian AS is recalling Cystatin C calibrators that may measure incorrect high values, potentially leading to falsely elevated patient results.
Lucky Spoon Bakery is recalling its Gluten Free Chocolate Celebration Cake because a batch of flour used in production tested positive for gluten.
Lucky Spoon Bakery is recalling gluten-free chocolate cupcakes because a flour supplier batch tested positive for gluten. The products were distributed in eight states and nationwide via drop ship.
Jakks Pacific is recalling MorfBoard Skate & Scoot Combo scooters with "Y" handlebars because the joint can break, posing a fall hazard.
Siemens is recalling Atellica CH Fructosamine tests because results may show a positive bias, potentially leading to incorrect glucose management and hypoglycemia.
Lucky Spoon Bakery is recalling gluten-free pumpkin cupcakes because a flour batch tested positive for gluten. The products were distributed in eight states and nationwide via drop ship.
CB2 is recalling Trace bookcases because the frame can collapse when fully loaded, posing an injury hazard. Consumers should stop using the units and contact CB2 for a replacement or refund.
Genicon, Inc. is recalling 10,808 units of the Aquas PowerFlow Tube Set because the device design did not receive proper premarket clearance from the FDA.
Mizuho OSI is recalling 174 Levo Arms used in spinal surgery tables due to a potential fluid ingress issue that could cause the locking mechanism to fail.
Skytron is recalling 36 SkyVision SDS System units because intermittent signal failures can cause monitors to go blank during surgery, increasing patient risk.