Baby and kids' product recalls

GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

A helmet that loosens or detaches increases the risk of injury during a crash.

Undeclared Allergen - Wheat

Product is recalled due to potential mold growth contamination.

Product is recalled due to potential mold growth contamination.

The cylindrical metal inserts in the crib's wooden frame can become loose and detach, posing a choking hazard.

The recalled light-up jelly ring toys violate the mandatory federal battery-operated toy regulation because the rings contain button cell batteries that fit within CPSC's small parts cylinder, and can be easily accessed without requiring the use of a common household tool. When button cell batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns and death, posing an ingestion hazard to children.

The youth ATVs fail to comply with the requirements of the federal mandatory ATV safety standard. The handlebars pose a laceration hazard if the child rider's body or head impacts the handlebars at a high rate of speed. Additionally, the parking brakes fail to hold, posing a collision hazard. The ATVs are also missing the required safety reflectors for vehicles intended for use by children 10 years and older. The 518 CY125ATV-6 model's footguards pose a laceration, contusion, and amputation hazard if the rider's foot enters the rear wheel environment. ATVs that fail to meet these mandatory safety requirements pose a risk of serious injury or death.

The swings pose a suffocation risk because they were marketed, intended, or designed for infant sleep, and they have an incline angle greater than 10 degrees in violation of the federal safety regulations for Infant Sleep Products and the Safe Sleep for Babies Act. The swings also violate other requirements for infant swings and the labeling requirements for Reese's Law because the remote contains a button or coin-cell battery.

The recalled bassinets violate federal safety regulations for Infant Sleep Products because they do not have a stand, posing a fall hazard if used on elevated surfaces.

The recalled cleaning product violates the Federal Hazardous Substances Act because it is deceptively labeled as "Safe and Non-Toxic" and lacks the required cautionary statements for petroleum distillates, posing a risk of poisoning to consumers.

The recalled toy guns fail to meet federal safety standards, as they do not have a blaze orange tip that is required by the mandatory toy standard to differentiate toy guns from real guns, and the projectiles pose an eye injury hazard to children because they do not meet the requirements in the mandatory toy standard for projectile toys.

The twin stroller violates multiple safety regulations for strollers. The front seat in the forward-facing configuration poses an entrapment hazard to children. In addition, failures with the restraint system and rear seat enclosure pose a fall hazard to children. In products with a black grab bar, the foam padding on the grab bar can pose a choking hazard if the child bites it.

The T-bar located at the front middle of the chair can become loose and fall or break off while the high chair is in use, posing a fall hazard to children.

Product may be contaminated with Listeria monocytogenes.

Microbial Contamination of Non-Sterile Products: presence of Terribacillus species organism

The wooden base can detach from the wooden rod and release the three plastic rings, posing a choking hazard to young children.

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.

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.