Baby and kids' product recalls

Produced Without Benefit of Inspection

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

The paint on the recalled electric bikes 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 paint on the recalled electric bikes 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 activity table contains a silver metal bell which can detach from its metal arch, posing a choking hazard to young children.

The recalled products contain diphenhydramine hydrochloride and acetaminophen 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.

Label lists squid; contains statement lists Fish(squid); other fish not listed in ingredients or contains statement

Colostrum is declared but label does not declare milk.

Potential undeclared allergen from cross contamination. Product contains tree nuts (hazelnuts and walnuts) and potential cross contamination from other tree nuts (almonds and cashews).

Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.

Superpotent Drug and Failed Impurities/Degradation Products: formula does not adhere to the labeled specifications

A child seat that fails to properly restrain a child increases the risk of injury in a crash.

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

The paint on the children's metal doll pins 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.

The recalled ATVs fail to comply with the mandatory requirements of the federal ATV safety standard, including parking brake requirements, posing a collision hazard to consumers if the vehicle is parked on an incline. The ATVs also fail to comply with other mandatory safety requirements for ATVs intended for children 10 years of age and older, including improper labeling and missing safety reflectors. ATVs that fail to meet the mandatory safety standard requirements pose a risk of serious injury or death.

The eyes on the toy can detach, posing a small part choking hazard to children.

The necklaces have high levels of cadmium. Cadmium is toxic if ingested by children and can cause adverse health effects.

The recalled ATVs fail to comply with the requirements of the federal mandatory ATV safety standard. The Ace-branded K125 and C125 models exceed the maximum speed limitations for vehicles intended for children aged 10 and older, posing a risk of high-speed crash. For T125 and C125 models, the parking brakes do not prevent movement of the vehicle, posing a collision hazard to consumers if the vehicle is parked on an incline. ATVs that fail to meet the mandatory safety requirements pose a risk of serious injury or death.

Cease use of the Habib EndoHPB Bipolar RF Catheter with the ERBE VIO3 Generator immediately due to the potential for delivery of excessive energy leading to thermal injury or tissue damage. An inaccurate setting is currently provided in the HABIB EndoHPB Catheter's Instructions for Use ("IFU").

The recalled helmets do not comply with the positional stability requirements of the CPSC federal safety standard for bicycle helmets. The helmets can fail to protect a child in the event of a crash, posing a risk of head injury.

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

The recalled children's sleepwear fails to meet the federal flammability standards for children's sleepwear, posing a risk of burn injuries to children.

The recalled children's sleepwear fails to meet the federal flammability standards for children's sleepwear, posing a risk of burn injuries to children.

The brake support for the rear brake of the inline skates can fracture or separate, which can reduce user stability, increasing the risk of a fall.

The fishing rods contain levels of lead that exceed the federal lead content ban. Lead is toxic if ingested by young children and can cause adverse health issues.

Misbranding, Unreported Allergens

Product Contamination

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