Baby and kids' product recalls

Misbranding, Unreported Allergens

Product Contamination

The recalled crib mattresses violate the federal safety regulation for mattresses by failing to meet the flammability and labeling requirements, posing a fire hazard to children.

The recalled high chair, which converts into a booster seat, violates the safety regulations for both high chairs and booster seats. Multiple failures were identified including, but not limited to, insufficient restraint system, stability, static load, latching and locking mechanisms, leg openings, warnings, labels, and literature. The product can tip over or collapse and present a fall hazard to children.

The plastic pieces on the end of the pants' faux drawstrings can come loose and fall off, posing a choking hazard.

The clasp on the braided black bracelet sold as part of the gift set contains high levels of lead and cadmium. Lead and cadmium are toxic and can cause adverse health effects in children.

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 CPSC's Infant Sleep Products Regulation and the Safe Sleep for Babies Act. In addition, the swing fails to meet mandatory warning requirements regarding sleep under the swing standard.

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Product Contamination

The recalled mouthwash contains ethanol in a concentration which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act (PPPA). The packaging of the products is not child-resistant, posing a risk of poisoning if the contents are swallowed by young children.

The paint or surface coating on the red mallet, blue mallet, red hoop, and winning post contain levels of lead that exceed the federal lead paint ban, posing a lead poisoning hazard. In addition, the coating on the red and blue mallets contains levels of regulated phthalates that exceed the prohibition of specific phthalates. Lead and phthalates are toxic if ingested by young children and can cause adverse health issues.

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

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

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

Product Contamination

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.