Baby and kids' product recalls

Misbranding, Unreported Allergens

The recalled mattresses violate multiple provisions of the federal safety regulation for crib mattresses, including the thickness test, and are missing warnings and labels. The product poses a suffocation hazard to infants.

The recalled mattresses violate multiple provisions of the federal safety regulation for crib mattresses, including the thickness test, and are missing warnings and labels. The product poses a suffocation hazard to infants.

While cleaning or disinfecting the system, if the process is not followed as described in the manual and excessive liquid is used or sprayed directly on the system, it could cause a short circuit of the fine positioning control button. This would result in the system moving on its own in a very slow speed forward circular motion.

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 530mL BRS bottle was manufactured after the Portable Fuel Container Safety Act (PFCSA) became effective and lacks a flame mitigation device, posing a flash fire hazard.

The strap anchor can become dislodged from the helmet when sufficient force is applied, and therefore violates 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.

Labeling: Not Elsewhere Classified; Product labeling contains the claim of 'Paraben Free' while the product does in fact contain parabens as part of the formulation/ ingredient list.

Processing Defect

The recalled children's bathrobes violate federal flammability regulations for children's sleepwear, posing a risk of burn injuries to children.

The lighters do not have child-resistant mechanisms and were not tested to the federal regulatory requirements for child resistance. Young children under 5 years old could ignite the lighters, posing fire and burn hazards.

Due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed and the product was inadvertently distributed.

During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.

During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.

Product contains undeclared Diclofenac and Dexamethasone Acetate

Import Violation

The bicycles do not meet U.S. safety standards for bicycles, posing crash and injury hazards to children. The 10-inch, 12-inch, and 16-inch bicycles are equipped with hand brakes but no footbrakes. The 20-inch bicycles are not equipped with a chain guard and the pedals do not come with reflectors. Federal regulations require bicycles with seat heights that measure at or below 25 inches to be equipped with foot brakes and require a full coverage chain guard, intended to prevent entrapment of clothing or body parts.

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

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

The packaging configuration can allow damage to the wooden knob on the Ball Run during shipping and cause it to come loose and detach, posing a choking hazard to children.

The rhinestones embedded in the recalled tiaras 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 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.

Product has the potential to be contaminated with Cronobacter sakazakii.

Product Contamination

Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled.

Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled.

Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).

Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).

Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).

Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).

Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).