Baby and kids' product recalls

An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.

An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.

The firm has not submitted the required premarket notification, parents and caregivers should understand that the products have not been evaluated to determine whether they meet U.S. food safety and nutritional standards.

The firm has not submitted the required premarket notification, parents and caregivers should understand that the products have not been evaluated to determine whether they meet U.S. food safety and nutritional standards. Cronobacter spp. detected by FDA sampling.

The firm has not submitted the required premarket notification, parents and caregivers should understand that the products have not been evaluated to determine whether they meet U.S. food safety and nutritional standards.

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

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

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

A potential issue with ARTIS icono systems equipped with a small detector and a corresponding collimator (model # 10843101) was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper prefiltration. If the described issue occurs, the applied radiation dose rate may be higher than intended by the user.

A potential issue with ARTIS icono systems equipped with a small detector and a corresponding collimator (model # 10843101) was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper prefiltration. If the described issue occurs, the applied radiation dose rate may be higher than intended by the user.

A potential issue with ARTIS icono systems equipped with a small detector and a corresponding collimator (model # 10843101) was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper prefiltration. If the described issue occurs, the applied radiation dose rate may be higher than intended by the user.

Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.

Potential Salmonella contamination

Salmonella contamination

The plastic housing surrounding the AC power adapter supplied with some Rest 1st Generation sound machines can come off when removing the adapter from the power outlet, leaving the power prongs exposed and posing a shock hazard to consumers.

The children's pajama sets violate the federal flammability standards for children's sleepwear, posing a burn hazard to children.

Misbranding, Unreported Allergens

A helmet that is not securely fastened can come loose or detach, increasing the risk of injury during a crash.

The recalled bookcase is unstable if it is not anchored to the wall, posing tip-over and entrapment hazards that can result in death or serious injuries to children.

The training wheel assembly knob can loosen and detach from the bicycle, posing fall and injury hazards to the riders.

The recalled Make It Mini sets contain resins that, when liquid, can cause skin, eye, and respiratory irritation or sensitization when inhaled, touched, or ingested by children or adults. The resins contain acrylates (hydroxyethylmethacrylate "HEMA" and isobornyl acrylate "IBOA") in amounts prohibited in children's products by the Federal Hazardous Substances Act. After the resins cure, they no longer present this hazard.

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 do not comply with the performance requirements of the STURDY Act.

The frames of the recalled cargo bicycles can crack and can bend and break, posing a fall hazard to the rider.

The brown handle strings contain levels of phthalates that exceed the federal phthalate ban. Phthalates are toxic if ingested by young children and can cause adverse health effects.

The Goat Milk Formula Recipe Kit has been sold and marketed as infant formula, but product has not submitted to FDA the premarket notification required for an infant formula for review.

Use of the blood pressure cuffs could result in inaccurate non-invasive blood pressure measurements.

Unfit for Human Consumption

Potential contamination with Listeria monocytogenes

The recalled sling carriers violate the safety requirements of the Safety Standard for Sling Carriers, including requirements for structural integrity and occupant retention, posing a fall hazard to babies. Additionally, the sling carriers pose a suffocation hazard because they fail to meet the federal safety standard's requirements for restraint systems, as the waist restraint can be used without the crotch restraint. Further, there are no warnings or instructional literature providing information to caregivers about keeping the baby's face clear to prevent suffocation or safe positioning, to prevent the baby from curling into a position with their chin resting on or near their chest. Sling carriers manufactured after January 30, 2018 are subject to the mandatory federal safety standard.

Out of Specification for active ingredient