Baby and kids' product recalls

The recalled dressers are unstable if they are not anchored to the wall, posing a serious tip-over and entrapment hazard that can result in death or injuries to children. The dressers do not comply with the performance requirements of the U.S. voluntary industry standard (ASTM F2057-14).

The knuckle that joins the wheel to the axle can break, posing a fall hazard to the rider.

GE Healthcare has recently become aware of a potential safety issue related to loose screws in the Heater Head of the Infant Warmer System (IWS). Hot screws from the Heater Head of the IWS could fall onto the bed if the Heater Head assembly has been improperly serviced. This situation can be clinically hazardous because thermal injury to a patient could result. Two injuries have been reported as a result of this issue.

Bard Access Systems announces a voluntary field action for the SafeStep¿ Huber Needle Set with Y-Injection Site and MiniLoc¿ Safety Infusion Set Winged without Y-Injection Site devices because sets may contain one or more units where the needle length and gage differs from the length and gage described on the label.

Bard Access Systems announces a voluntary field action for the SafeStep¿ Huber Needle Set with Y-Injection Site and MiniLoc¿ Safety Infusion Set Winged without Y-Injection Site devices because sets may contain one or more units where the needle length and gage differs from the length and gage described on the label.

The wheels on the mobile's hanging cars can detach and fall, posing a choking hazard to young children.

A seal quality issue with the packaging may result in the food spoiling causing package swelling (bloating)

The recalled chests are unstable if they are not anchored to the wall, posing a serious tip-over and entrapment hazard that can result in death or injuries to children.

Excessive lead paint levels on the yellow shank and black blade on the shovel, and the black paint on the garden tool set violates the federal lead paint standard. In addition, the black plastic shovel handle and bag clip on the garden tool drawstring bag contain excessive lead content levels, a violation of the federal lead standard. Lead is toxic if ingested by young children and can cause adverse health effect.

Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.

Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.

CGMP Deviations

CGMP Deviations

CGMP Deviations

The snaps on the hoodies can detach, posing a choking hazard to young children.

If the infant carrier does not properly attach to the base, the carrier can detach in a crash, increasing the risk of injury.

The front wheels of the scooter can detach when riding, posing a fall hazard.

Cookies may contain metal pieces.

The metal snaps on the jackets can detach, posing a choking hazard to children.

Product Contamination

The firm sent the Technical Bulletin to consignees who received the reliability updated neoBLUE blanket LED Phototherapy Systems between March 2016 to August 2016. The reliability update to prevent the early failure of the fiberoptic pads experienced by some customers on older systems. These failures on previous systems involved discoloration and melting of the fiberoptic bundle at the connector that is inserted in the neoBLUE blanket light box.

It was discovered that a non-sterile vacuum tube is supplied within the pack, although the Instructions for Use (IFU) describe the use of a sterile vacuum tube as part of the procedure setup.

Edits to Particle field definition parameters may not be saved when the field definition window is saved.

Customer reported a small piece of rubber inside one variety of the recalled product.

Customer reported a small piece of rubber inside one variety of the recalled product.

Customer reported a small piece of rubber inside one variety of the recalled product.

Customer reported a small piece of rubber inside one variety of the recalled product.

Customer reported a small piece of rubber inside one variety of the recalled product.

Customer reported a small piece of rubber inside one variety of the recalled product.

A gap in the stroller's folding side hinge can pinch a caregiver's hand during unfolding, posing a laceration hazard. In addition, the stroller can fold unexpectedly during use, posing an injury and fall hazard to the caregiver and child.