Baby and kids' product recalls

After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distributed or sold without new 510(k) clearance.

After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distributed or sold without new 510(k) clearance.

After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distributed or sold without new 510(k) clearance.

The over-the-counter drug products contain regulated substances which must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the products is not child resistant, posing a risk of poisoning if the contents are swallowed by young children.

The recalled nightgowns fail to meet flammability standards for children's sleepwear, posing a risk of burn injuries to children.

Product is labeled as non-pyrogenic but endotoxin testing was not performed.

Product is marketed as an infant formula but the required pre-market infant formula notification for this product has not been submitted to the FDA. Product tested by FDA was well above the maximum acceptable range for Iron, Potassium and Sodium, which could potentially lead to iron overload and/or electrolyte imbalances. In addition, the product did not have vitamin D, and a vitamin D deficiency can potentially lead to rickets, a softening and weakening of bones.

The recalled children's sleepwear garments fail to meet the United States flammability standards for children's sleepwear, posing a risk of burn injuries to children.

The base of the silicone nipple has a fine slit that can cause the nipple to detach from the plastic shield, posing a choking hazard.

The recalled robes fail to meet flammability standards for children's sleepwear, posing a risk of burn injuries to children.

The youth ATVs fail to comply with the requirements of the federal mandatory ATV safety standard. Children can operate them above the maximum allowed speed, increasing the risk of a crash that can cause serious injuries. The handlebars pose a laceration hazard should the child rider's body or head impact the handlebars at a high rate of speed such as in a crash. In addition, the parking brake does not prevent the movement of the vehicle at the minimum required steepness. ATVs that fail to meet the mandatory safety requirements pose a risk of serious injury or death to children.

Young children can become entrapped in the space between the exterior landing (hoistway) door and the interior elevator car door or gate due to a hazardous gap, and suffer serious injuries or death when the elevator is called to another floor.

Young children can become entrapped in the space between the exterior landing (hoistway) door and the interior elevator car door or gate if there is a hazardous gap, and suffer serious injuries or death when the elevator is called to another floor.

Young children can become entrapped in the space between the exterior landing (hoistway) door and the interior elevator car door or gate if there is a hazardous gap, and suffer serious injuries or death when the elevator is called to another floor.

The inner layer of the fuel line can leak, posing a fire hazard.

Paint on the wood wagons, the plastic handles, and the red plastic cover contain levels of lead that exceed the maximums allowed. Excessive levels of lead can be toxic or cause other health problems to young children if the paint is ingested.

Product Contamination

Supplement contains undeclared milk from MCT oil powder ingredient.

Paint on the zipper pull contains levels of lead that exceed the maximums allowed. Excessive levels of lead can be toxic or cause other health problems to young children if the paint is ingested.

The CRT Motor youth model ATVs do not meet mandatory safety requirements. Children can operate them above the maximum allowed speed, increasing the risk of a crash that can cause serious injuries. In addition, the handlebars pose a laceration hazard should the child rider's body or head impact the handlebars at a high rate of speed such as in a crash.

Undeclared fish allergen

Potential for metal in product

Microbial Contamination of Non-Sterile Products

Probiotic products contaminated with Pseudomonas aeruginosa .

Probiotic products contaminated with Pseudomonas aeruginosa .

Probiotic products contaminated with Pseudomonas aeruginosa .

The metal hook fastening the ladder to the top bunk bed frame can move away or detach from the bed frame when the ladder is lifted, causing the gap between the ladder step and bed frame to open wider than 3.5 inches, posing serious entrapment and strangulation hazards.

Detached pieces of the labels can present a choking hazard to a child, increasing the risk of injury.

The bath seats fail to meet the federal safety standard for infant bath seats, including requirements for stability and leg openings, and can tip over while in use, posing a drowning hazard to babies.

Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.