All recalls8,424 total
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Undeclared allergen (egg)
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Lack of assurance of sterility. The recall is due to potential contamination
Presence of Particulate Matter
Undeclared milk from lactose.
shortfill; reports of empty capsules.
CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.
The recalled teething toys violate the mandatory standard for toys because the silicone strings are smaller and longer than permitted. The strings can reach the back of children's throat and become lodged, posing a serious risk of respiratory distress and deadly choking hazard.
The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risk of serious injuries or death to children. The dressers violate the mandatory safety standards as required by the STURDY Act.
The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or death to children. The dressers violate the mandatory safety standards as required by the STURDY Act.
The recalled teething toy sets contain a pull string teething toy that violates the mandatory standard for toys because the silicone strings are smaller and longer than permitted. The strings can reach the back of a child's throat and become lodged, posing a risk of respiratory distress and a deadly choking hazard.
The recalled drain covers violate the entrapment protection standards of the Virginia Graeme Baker Pool and Spa Safety Act (VGBA), posing deadly entrapment and drowning hazards to consumers.
The recalled drain covers violate the entrapment protection standards of the Virginia Graeme Baker Pool and Spa Safety Act (VGBA), posing deadly entrapment and drowning hazards to consumers.
The snap can detach from the recalled bibs and stroller bags, posing a risk of serious injury or death from a choking hazard to young children.
Label declares cream and cheese, but Milk is not declared
Possible Salmonella Enteritidis
Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.
Possible Salmonella Enteritidis
Possible Salmonella in Moringa Leaf Powder product.
Undeclared Soy. The firm received complaints of sausage in the burritos. Upon review the firm discovered the sausage contains soy which is not listed on the label.
Potential Cyclospora contamination.
Presence of Particulate Matter; identified as stainless steel
Presence of Particulate Matter; identified as stainless steel
Certain lots of Neisseria meningitidis Gp C 2ml/VL, R30166901, are not performing to IFU criteria not positive to ATCC13102 within 60 Seconds.
The recalled chandeliers lack proper electrical grounding, posing a risk of serious injury or death from electrocution hazard.
The sandals' decorative pearls can fall off, posing a risk of serious injury or death from a choking hazard.
The power cord insulation can be insufficient due to a protective fiberglass sleeve not covering it adequately, posing a risk of shock and/or fire hazard.
The regulator inlet tube can crack and break, posing a risk of serious injury or death from drowning.
The recalled tower stools can collapse or tip over while in use, and a child's torso can fit through the openings on the front and back sides, posing a risk of serious injury and death due to tip over, fall and entrapment hazards.
The lighters violate the mandatory safety standard for multipurpose lighters because they do not have the required child-resistant mechanisms posing a risk of serious injury or death from fire and burn hazards. In addition, the lighters failed to meet the pre-market lighter submission requirement needed to demonstrate that the lighters feature child-resistant mechanisms and ensuring their safety and compliance with U.S. regulations.
The paint thinner contains low-viscosity petroleum distillates, which must be in child-resistant packaging, as required by the?Poison Prevention Packaging Act. The bottles are not child-resistant, posing a risk of serious injury or death from poisoning if the contents are swallowed by young children. Additionally, petroleum distillates can get into the lungs, causing chemical pneumonia and/or pulmonary damage, which can be fatal.
The recalled sweaters violate the mandatory standard for clothing textiles, posing a risk of serious burn injuries or death.
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Incorrect Product Formulation
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
The recalled bed rails violate the mandatory standard for adult portable bed rails because users can become entrapped within the bed rail or between the bed rail and the side of the mattress, posing a serious entrapment hazard and risk of death by asphyxiation. The bed rails do not meet structural stability or retention strap requirements, posing a fall hazard. Additionally, the bed rails' push pins and push pin holes are incorrectly sized, posing a laceration hazard.
The recalled bed rails violate the mandatory standard for adult portable bed rails because users can become entrapped within the bed rail or between the bed rail and the side of the mattress, posing a serious entrapment hazard and risk of death by asphyxiation. In addition, the bed rails do not bear the required hazard warning labels.
The recalled finger lights violate the mandatory safety standard for toys because they contain button cell batteries that can be easily accessed by children. If button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, including internal chemical burns, and death.
The recalled toddler towers can tip over while in use, posing a risk of serious injury and death, due to tip over and fall hazards.
The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or death to children. The dressers violate the mandatory safety standard as required by the STURDY Act.
The cup in the lunch boxes contains high lead concentration levels for drinking vessels, posing a lead poisoning hazard. Lead is toxic if ingested by adults or children and can cause adverse health issues.
Presence of Particulate Matter: Hair was found in products
Presence of Particulate Matter: Hair was found in products
Presence of Particulate Matter: Hair was found in products
Presence of Particulate Matter: Hair was found in product
Firm has identified mismatches between the outbreak strain and the reference strain used in the development of its qualitative, multiplexed, nucleic acid-based in vitro diagnostic panel test.
Two software related issues: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geometry movements that may lead to delay of therapy and procedural complications