Baby and kids' product recalls

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.

When appending a care plan that contains one or more wave medication orders, the occurrence and frequency of the appended orders may not match the intended schedule.

The recalled children's and youth helmets violate the mandatory safety standard for bicycle helmets. Particularly, the helmets do not comply with the positional stability and coverage requirements. The helmets can fail to protect the user in the event of a crash, posing a risk of injury or death due to head injury.

The high chairs violate the mandatory standard for high chairs because they were sold without the required attached restraint system, posing a deadly fall hazard to babies. In addition, a child's head can become trapped in the opening between the seat and tray, posing a deadly entrapment hazard.

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 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 slat and the side wall, posing a risk of serious injury or death due to entrapment.

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 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 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 recalled dressers are unstable if they are not anchored to the wall, posing 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 recalled magnet spinner 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 recalled pajama sets violate the mandatory standards for children's sleepwear, posing a risk of serious injuries or deadly burn hazard to children.

The play yards violate the mandatory standard for play yards. Infants can become entrapped under the mattress or between the side of the play yard and the mattress, posing a risk of serious injury or deadly suffocation hazard.

The platform inside the tower can collapse, posing a fall hazard to young children.

The recalled baby loungers violate the mandatory standard for Infant Sleep Products. The sides are too low to contain an infant. The enclosed openings at the foot of the loungers are wider than allowed, posing 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 stroller violates the mandatory standard for strollers because the restraint system can fail, posing a risk of serious injury or deadly fall hazard.

Undeclared peanut.

The recalled sleep sacks violate the mandatory flammability standard for children's sleepwear, posing a burn hazard and risk of serious injury or death to children.

The button cell and lithium coin batteries are not in child-resistant packaging and do not bear the warning labels required under Reese's Law. If a child swallows button cell or coin batteries, the ingested batteries can cause serious injuries, including internal chemical burns and death.

The recalled silicone activity toys contain spherical ends that can reach the back of the throat, posing a serious choking hazard to children.

The doll sets violate the mandatory standard for toys because the battery compartment of the unicorn contains button cell batteries 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.

Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be missing a required Certification Statement under 21 CFR Subchapter J (Radiological Health Regulations). Specifically, the following statement may have been omitted: Certification Statement: This electronic product complies with all applicable performance standards prescribed under 21 CFR Subchapter J, as enforced by the U.S. Food and Drug Administration at the date of manufacturing.

Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be missing a required Certification Statement under 21 CFR Subchapter J (Radiological Health Regulations). Specifically, the following statement may have been omitted: Certification Statement: This electronic product complies with all applicable performance standards prescribed under 21 CFR Subchapter J, as enforced by the U.S. Food and Drug Administration at the date of manufacturing.

Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be missing a required Certification Statement under 21 CFR Subchapter J (Radiological Health Regulations). Specifically, the following statement may have been omitted: Certification Statement: This electronic product complies with all applicable performance standards prescribed under 21 CFR Subchapter J, as enforced by the U.S. Food and Drug Administration at the date of manufacturing.

The recalled bed rails violate the mandatory standard for children's portable bed rails because, when installed adjacent to the bed, the child can become entrapped in the enclosed openings, the openings on the side of the mattress, and the openings on top of the mattress, posing a risk of serious injury or death due to entrapment.

The recalled toys are intended for children under three years of age and the eyes can detach, which violates the small parts ban, posing a choking hazard to children.

The swings were marketed for infant sleep and have an incline angle greater than 10 degrees, violating the mandatory safety standard for Infant Sleep Products and the ban on inclined sleepers under the Safe Sleep for Babies Act, posing a deadly suffocation risk.

The recalled nightgowns violate the mandatory flammability standards for children's sleepwear, posing a risk of burn injuries to children.

The recalled infant bath tubs violate the mandatory standard for consumer products containing button cell or coin batteries because the built-in thermometer contains button cell batteries that can be accessed easily by children. When button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns and death.

The left front wheel can detach during use, posing a fall hazard.