Baby and kids' product recalls

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.

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, posing a deadly entrapment hazard. Babies can suffocate 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 non-full-sized crib mattress also fails to meet the mandatory standard for mattress set flammability.

Vantive has identified a software defect within the Sharesource Claria software, which may cause a patient s updated prescription program settings to not be properly saved on the actual cycler that the patient is using to perform their therapy. As a result, the clinician may think that the patient is receiving the correct prescribed therapy because of what is erroneously displayed on the clinician's remote Sharesource application, when in fact the cycler that is with the patient is actually delivering an outdated and incorrect therapy.

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 candle contains ornaments that are flammable, posing fire and burn hazards.

The high chairs pose a risk of serious injury or death to children because they violate the mandatory standard for high chairs. The high chairs were sold without the required attached restraint system, posing a serious risk of falls to children. In addition, a child's head can become trapped in the opening created between the seat and the tray, posing a deadly entrapment hazard.

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

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 required by the STURDY Act.

A drawstring in the hood of the recalled jackets presents a substantial product hazard as it can get caught on objects and cause death or serious injury to children, due to strangulation.

The after-market play yard mattresses may not adequately fit certain play yards, which is in violation of the mandatory standard for crib mattresses, posing a deadly entrapment hazard. Babies have suffocated 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 dressers are unstable if they are not anchored to a 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 fuel containers violate the mandatory safety standards for portable fuel containers because they lack flame mitigation devices required under the Portable Fuel Container Safety Act, posing a deadly risk of flash fire. In addition, the Children's Gasoline Burn Prevention Act requires all closures on portable gasoline fuel containers to be child resistant. The spout on the products is not child-resistant, posing a risk of burn and poisoning to children.

The recalled fuel containers violate the mandatory safety standards for portable fuel containers because they lack flame mitigation devices required under the Portable Fuel Container Safety Act, posing a deadly risk of flash fire. In addition, the Children's Gasoline Burn Prevention Act requires all closures on portable gasoline fuel containers to be child resistant. The spout on the product is not child-resistant, posing a risk of burn and poisoning to children.

The utility wagon violates the mandatory standard for strollers because an opening between the organizational tray and the sidewall may cause a child's head to become entrapped, posing a risk of serious injury or death. In addition, the utility wagon's lack of a restraint system poses a risk of falls to children.

The recalled plastic tip restraint kits (also referred to as furniture straps) can break or degrade, posing tip-over and entrapment hazards that can result in serious injuries or death to children or elderly consumers interacting with furniture that is secured to the wall with the defective plastic tip restraints.

Wound dressing may have foreign matter on the product.

IFU update; in-line valve, with pressure relief seal may leak when used with ventilator; don't use in neonates/infants, with target tidal volumes less-than50mL or less-than10kg- at high risk of cardiopulmonary/neurological compromise due to unrecognized hypoventilation, updates for continued use in others before design update; leak may cause respiratory acidosis, hypoxemia, or respiratory failure.

Potential Salmonella contamination.