Baby and kids' product recalls

The recalled magnetic stick figure toy sets violate the mandatory standard for toys because the sets contain loose magnets, posing an ingestion hazard to children. When high-powered magnets are swallowed, they 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 magnet ball toys violate the mandatory standard for toys because they are loose high-powered magnets, posing an ingestion hazard to children. When high-powered magnets are swallowed, they 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 lighters violate the mandatory 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.

The recalled toys violate the mandatory standard for toys because they contain high-powered magnets which can loosen and 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 teething toys violate the mandatory standard for toys because the silicone strings are smaller than permitted. The silicone strings can reach the back of the throat and become lodged, posing a risk of respiratory distress, serious choking hazard and death.

Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

A child seat with a missing tether strap may not adequately protect a child in a crash, increasing the risk of injury.

The beard growth serum contains minoxidil, which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act. The 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 recalled self-feeding pillows hold the bottle at an unsafe angle while keeping it fixed in place so the infant cannot pull away. This can lead to aspiration of milk or formula, posing a risk of suffocation.

The recalled children's pajamas violate the mandatory standards for flammability of children's sleepwear, posing a risk of serious injury and deadly burn hazards to children.

The aftermarket mattresses violate the mandatory standard for crib mattresses, as the mattresses may not adequately fit certain play yards or non-full-sized cribs, which could create gaps posing a deadly entrapment hazard. Babies can face a risk of suffocation in gaps between an undersized mattress, or extra padding, and side walls of a product, especially when the infant's face becomes trapped against the side and the mattress, preventing the infant from breathing.

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.

The serum bottles contain minoxidil, which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act. The 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.

cGMP Deviations

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.

Foreign object