Baby and kids' product recalls

cGMP Deviations

The recalled baby loungers violate the mandatory safety standard for Infant Sleep Products. The sides are too low to contain an infant and the enclosed openings at the foot of the loungers are wider than allowed, posing serious risks of fall and entrapment hazards to infants. In addition, the baby loungers do not have a stand, posing a fall hazard if used on elevated surfaces. These violations create an unsafe sleeping environment and can cause death or serious injury to infants.

The recalled toy kits violate the mandatory standard for toys containing button cell batteries because the compartment that holds the batteries can be easily accessed and opened by children, posing a deadly ingestion hazard to children. When button cell and coin batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns and death.

The recalled pounding toys violate the mandatory standard for toys because they contain high-powered magnets, which can detach, posing an ingestion hazard to children. When high-powered magnets are swallowed, the ingested magnets can attract each other, or other metal objects, and become lodged in the digestive system. This can result in perforations, twisting and/or blockage of the intestines, blood poisoning, and death.

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 standard 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 a risk of serious injuries or death to children. The dressers violate the mandatory standard as required by the STURDY Act.

The recalled bath seats violate the mandatory standard for infant bath seats because they are unstable and can tip over while in use, and have leg openings that allow the child to slip down until the child's torso can become entrapped, posing a risk of serious injury or death due to drowning and entrapment.

The pajama pants and shorts violate the mandatory standards for flammability of children's sleepwear, posing a risk of burn injuries to children.

The recalled padded crib bumpers violate the federal ban on crib bumpers because they can obstruct an infant's breathing, posing a risk of serious injury or death, due to suffocation. This creates an unsafe sleeping environment for infants. Padded crib bumpers are banned by the federal Safe Sleep for Babies Act.

The recalled gates violate the mandatory standard for expansion gates and expandable enclosures because a child's torso can fit through the opening between the gate and the floor, becoming entrapped, posing a risk of serious injury or death.

Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label

Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label

Product Contamination

Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval.

A child seat that does not maintain proper recline position may not adequately secure a child in a crash, increasing the risk of injury. Additionally, should another passenger put their hand in the recline mechanism when it shifts out of position, their risk of injury is increased.

The children's toy violates the mandatory standard for toys because the toy cell phone contains button cell batteries and the toy tablet contains a lithium coin battery that can be easily accessed by children. When button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns and death.

The compression strap that surrounds the outside of the pool legs may create a foothold, allowing a child access to the pool, posing a drowning risk.

The recalled dressers are unstable if they are not anchored to the wall, posing a serious tip-over and entrapment hazards that can result in injuries or death to children. The dressers violate the mandatory standard as required by the STURDY Act.

The beard serum contains minoxidil, which must be in child-resistant packaging as required by the Poison Prevention Packaging Act. The hair serum's packaging is not child-resistant, posing a risk of serious injury or death from poisoning if the contents are swallowed by young children.

The ointment contains lidocaine, which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act. The ointment's packaging is not child-resistant, posing a risk of serious injury or death from poisoning if the contents are swallowed by young children.

The recalled dressers are unstable if they are not anchored to the wall, posing serious tip-over and entrapment hazard that can result in injuries or death to children. The dressers violate the mandatory standard 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 serious injuries or death to children. The dressers violate the mandatory standard as required by the STURDY Act.

The buckles securing the restraints around the child can release during use, posing a fall hazard.

The arm on the MP2 model of the fitness machine does not lock properly, which can allow the arm to swing unexpectedly, posing a risk of laceration or serious injury.

Wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Electrical arcing remains internal within the unit (no risk of shock to users).

Wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Electrical arcing remains internal within the unit (no risk of shock to users).

Product tested positive Salmonella .

Contaminated with Clostridium botulinum

Incorrect Product Formulation