Baby and kids' product recalls

Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates .

Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates .

Allergens of almonds and milk not declared on the product ingredient label

The lower side of the stroller frame can crack, posing a fall risk to children in the stroller.

Premature pump failure may lead to the device displaying a HALT 4 error, from which the device cannot recover even after device reboot. The issue may potentially lead to delayed treatment and a failure to deliver the prescribed thermoregulation therapy. To date, the firm has received one report of death potentially related to this issue.

undeclared peanut

Surface paint on the miniature skateboard and scooter toys in the ramp sets contain levels of lead that exceed the federal lead paint ban, posing a risk of lead poisoning. The miniature scooter toy also fails to comply with the federal lead content ban. Lead is toxic if ingested by young children and can cause adverse health effects.

The yellow-painted metal zipper contains levels of lead that exceed the federal lead paint ban, posing a lead poisoning hazard; the orange plastic phone cord contains levels of lead that exceed the federal lead content ban; and the horn's blue plastic bulb contains a regulated phthalate that exceed the prohibition of specific phthalates. Phthalates and lead are toxic if ingested by young children and can cause adverse health issues.

The product contains low-viscosity petroleum distillates which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act (PPPA). The packaging of the product is not child resistant. Petroleum distillates can get into the lungs causing chemical pneumonia and/or pulmonary damage which can be fatal. In addition, the label on the products violates the Federal Hazardous Substance Act (FHSA) by omitting mandatory information on the packaging.

The paint on the recalled scooters contains levels of lead that exceed the federal lead paint ban, posing a lead poisoning hazard. Lead is toxic if ingested by young children and can cause adverse health issues.

The balloon volume is incorrectly described as 34cc instead of 40cc on one of the three internal labels enclosed for hospital use. A labelling error may result in user confusion and/or delay in initiating therapy. Therapy delays may impact those patients who are more hemodynamically unstable.

The Cyberquad fails to comply with the federal mandatory safety standard requirements for youth ATVs, including mechanical suspension and maximum tire pressure. Additionally, the Cyberquad lacks a CPSC-approved ATV action plan, which is required to manufacture, import, sell, or distribute ATVs.

The product label claim for copper is 0.5mg, but third-party lab results revealed product contains higher levels of copper.

The recalled products may contain bacteria, including Pseudomonas aeruginosa, an environmental organism found widely in soil and water. People with weakened immune systems or external medical devices who are exposed to Pseudomonas aeruginosa face a risk of serious infection that may require medical treatment. The bacteria can enter the body if inhaled, through the eyes, or through a break in the skin. People with healthy immune systems are usually not affected by the bacteria.

Components of the recalled butterfly net sets and the action figure playsets contain levels of certain phthalates and lead that exceed the federal phthalate and lead content standards. Phthalates and lead are toxic if ingested by young children and can cause adverse health issues.

The threads in the recalled woven baby blankets can come loose and detach posing choking, entrapment and strangulation hazards.

A helmet that does not provide adequate impact protection increases the risk of injury during a crash.

Product Contamination

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

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

The red cube can come apart or detach during use and release the small white ball inside the cube, posing a choking hazard to infants.

The metal base of the ring contains levels of lead that exceed the federal lead content ban. Lead is toxic if ingested by young children and can cause adverse health issues.

No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.

Labeling: Not Elsewhere Classified - Incorrect label-incorrect scent listed on label.

The surface paint on the tan side panels of the desks and storage units contains levels of lead that exceed the federal lead paint ban, posing a lead poisoning hazard. Lead is toxic if ingested by young children and can cause adverse health effects.

Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

The product does not conform to the FDA's infant formula standards for sale in the United States.

Incorrect Product Formulation: Oxytocin 30 units was added to an IV bag of 0.45% Sodium Chloride (500mL) instead of 0.9% Sodium Chloride (500mL).

The space between the second rung of the bed's ladder and the lower bunk frame is wider than 3.5 inches, posing an entrapment hazard to children, when the mattress is removed.

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 between the doors and suffer serious injuries or death when the elevator is called to another floor.