Baby and kids' product recalls

A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.

A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.

Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection

Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection

Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection

This recall is part of a 2-issue recall for the same system. When using the IVC needle position button, on the IVC control box during a series of scans, the plan box may not move to the desired needle position. This issue could result in the gantry moving to a location the operator does not expect. If this occurs, it presents a risk that the scan could occur at an incorrect location, or that the unintended motion of the gantry could cause a collision with the user or needle. The other part of the recall involves a software crash when the CCT foot pedal is activated (as described in RES ID93363).

The bottom exterior of the recalled stainless-steel cups contains an accessible solder bead with levels of lead that exceed the federal lead content ban. Lead is toxic if ingested by young children and can cause adverse health effects. In addition, the lid can crack and break during use producing sharp edges and small parts, posing choking and laceration hazards to children.

Product Contamination

The stems of the toy mushrooms can detach, posing a choking hazard to young children.

The bottom exterior of the stainless-steel cups contains an accessible solder bead with levels of lead that exceed the federal lead content ban. Lead is toxic if ingested by young children and can cause adverse health effects. In addition, the lid can crack and break during use producing sharp edges and small parts, posing choking and laceration hazards to children.

A plastic buckle that supports the back of the chair can break when a consumer is seated in the chair, posing a fall hazard.

Marketed towards preterm infants without approval as a new drug or licensed biologic, as well as unsafe food additive

Incorrect Product Formulation: product contains Active Ingredient Glandula Suprarenalis Suis 8X instead of Glandula Suprarenalis Bovine 8X (as stated on the product label).

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

Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.

A child seat missing warning labels will not inform the owner of critical safety information, which can increase the risk of injury for the child seat occupant.

The bath seats fail to meet the federal safety regulation for infant bath seats, including requirements for stability and leg openings, and can tip over while in use, posing a drowning hazard to babies.

The recalled children's craft buttons contain levels of lead that exceed the federal lead content ban. Lead is toxic if ingested by young children and can cause adverse health effects.

The recalled loungers fail to meet the safety requirements of CPSC's Infant Sleep Products Rule, creating an unsafe sleeping environment for infants and posing a suffocation risk and fall and entrapment hazards to infants. The failures include not having a stand and not meeting the requirements for side height and fabric-sided openings. The product's sides are shorter than the minimum side height limit; the sleeping pad's thickness exceeds the maximum limit; and an infant could fall out of an enclosed opening at the foot of the lounger or become entrapped.

Misbranding, Unreported Allergens

May have a battery life lasting less than the full 48 hours, requiring the device to be charged more frequently.

The activity centers' straps can detach or break while a child is in the activity center, posing fall and injury hazards to the child.

Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis

Import Violation

When global edit is used to update multiple formulary properties simultaneously, the following properties: 1) Require Lot Number on Recall, 2) Access Destruction Bin (Witness), 3) Add to Destruction Bin (Count/Empty), 4) CII Safe Stock Out Notice are, without user warning, overwritten to the value NO , which could result in diversion of controlled substances from the automated dispensing cabinet.

Potential PCBA leaching from tubing of hemodialysis machines.

Potential PCBA leaching from tubing of hemodialysis machines.

Potential PCBA leaching from tubing of hemodialysis machines.

Potential PCBA leaching from tubing of hemodialysis machines.

Unapproved food additive.