Baby and kids' product recalls

Infants can suffocate if they roll or move on the crib bumper in a position that obstructs breathing. Padded crib bumpers are banned under federal law.

FDA inspection and investigation of firm's website and social media pages found that Sammy's online marketing materials included misleading information that implied the product was safe as a sole source of nutrition for infants. Sammy's Milk has not submitted to FDA the premarket notification required for an infant formula, and the product is not manufactured in compliance with the infant formula requirements.

FDA inspection and investigation of firm's website and social media pages found that Sammy's online marketing materials included misleading information that implied the product was safe for use as a sole source of nutrition for infants. Sammy's Milk has not submitted to FDA the premarket notification required for an infant formula, and the product is not manufactured in compliance with the infant formula requirements.

The recalled products contain either ethylene glycol or low-viscosity petroleum distillates, which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act (PPPA). The packaging for the products is not child resistant, posing a risk of poisoning if the contents are swallowed by young children. Additionally, petroleum distillates can get into the lungs, causing chemical pneumonia and/or pulmonary damage, which can be fatal.

Safety Information: Complaints describe complications/adverse events that include pain, infection, rash, device migration, device erosion, seroma, discomfort, or other complications from feeling the device in the breast, and the need for additional medical treatment to remove the device

During an FDA Inspection it was discovered swollen and leaking cans.

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

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

The pinwheel's fastener cap can come loose and detach, posing a choking hazard to young children.

manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel

The recalled foam pattern rollers are intended for children and contain levels of lead that exceed the federal lead content ban in the rollers' handles. Lead is toxic if ingested by young children and can cause adverse health effects.

The recalled dressers are unstable if they are not properly anchored to the wall, posing serious tip-over and entrapment hazards that can result in injuries or death to children. The dressers violate the performance requirements of the STURDY Act.

The children's pajama sets fail to meet the flammability regulations for children's sleepwear, posing a risk of burn injuries to children.

The silicone cover on the sipper can detach while in use, posing a choking hazard to children.

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.

Product Contamination

The helmets do not comply with the dynamic strength of retention system, impact attenuation and certification requirements of the CPSC federal safety regulation for bicycle helmets. The helmets can fail to protect in the event of a crash, posing a risk of head injury.

If the acceleration pedal on the battery-operated ride-on toy becomes clogged with debris, it can stick after the user's foot is removed from the pedal, posing a crash hazard.

The recalled log splitter's hydraulic cylinder rod can separate from the piston, preventing the wedge from retracting. Reengaging the rod to the piston can cause the rod and wedge to move unexpectedly, posing injury hazards.

The children's pajamas fail to meet the flammability standards for children's sleepwear, posing a burn hazard to children.

Product Contamination

The portable fuel containers do not meet the child-resistant requirements for closures under the Children's Gasoline Burn Prevention Act (CGBPA). The closure for the products is not child resistant, posing a risk of burns and poisoning to children.

The helmets do not comply with the positional stability, dynamic strength of retention system, impact attenuation, and certification requirements in violation of the CPSC federal safety regulation for bicycle helmets. The helmets can fail to protect in the event of a crash, posing a risk of head injury.

Pieces of broken needles were found inside some quilts and quilted shams, posing a laceration hazard.

The portable fuel bottles do not meet the child-resistant requirements for closures under the Children's Gasoline Burn Prevention Act (CGBPA). The closure for the products is not child-resistant, posing a risk of burn and poisoning to children.

The speaker's lithium-ion battery can overheat and catch fire, posing burn and fire hazards to consumers.

Pressure relief valve included in certain lots of cardiovascular procedure kits was reportedly opening at approximately 200-300mmHg versus 400mmHg, potential myocardial tissue damage potentially requiring surgical or medical/pharmacological intervention

The outer packaging meant to prevent access to the contents can split open near the zipper track, posing a risk of serious injury to children and other vulnerable populations if the contents of the laundry detergent packets are ingested, as well as posing a risk of skin or eye injuries. Ingestion of a large quantity of any surfactant-containing household cleaning products can cause death among individuals with underlying health issues.

Infants can suffocate if they roll or move on the crib bumper in a position that obstructs breathing. Padded crib bumpers are banned under the Safe Sleep for Babies Act of 2021.