Baby and kids' product recalls

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.

The crayons in the coloring set have high levels of strontium and aluminum, and this may present a risk if ingested, posing a poisoning hazard if ingested by young children.

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 legs of the plush toy can detach from the body allowing the release of small beads that are on the legs, posing a choking hazard to young children.

The recalled LED lights violate the mandatory standard for consumer products containing button cell or coin batteries because they contain lithium coin batteries that can be accessed easily by children, posing an ingestion hazard. Additionally, the LED lights do not have the warnings required by Reese's Law. When button cell and coin batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns, and death.

The bottles are filled with dietary supplements containing iron, which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act. The packaging is not child-resistant, posing a risk of serious injury or death from poisoning if the contents are swallowed by young children.

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

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

Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed.

Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed.

Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed.

Potential exposure of rodents and rodent activity in the distribution center.

The recalled baby gyms violate the mandatory safety standard for infant support cushions because the floor mats can obstruct an infant's breathing, posing a serious risk of injury or deadly suffocation hazard.

The recalled spray bottles contain minoxidil, which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act. The 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 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, posing a risk of serious injury or death due to entrapment.

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.

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