Baby and kids' product recalls

Microbial Contamination of Non-Sterile Product: Out-of-specification results obtained for total aerobic microbial count (TAMC).

The youth ATVs fail to comply with the requirements of the federal mandatory ATV safety standard, including maximum speed limitations and other mandatory safety requirements for vehicles intended for children under 10 years of age. ATVs that fail to meet the mandatory safety requirements pose a risk of serious injury or death to children.

The Venom Motorsports youth model ATVs do not meet mandatory safety requirements, including speed restrictions, posing a risk of serious injury or death. The ATVs also were imported and distributed in the U.S. without a Consumer Product Safety Commission (CPSC)-approved ATV Action Plan, which includes safety requirements designed to protect users.

Infants can suffocate if they roll, move, or are placed on the lounger in a position that obstructs breathing, or roll off the lounger onto an external surface, such as an adult pillow or soft bedding that obstructs breathing.

Product recalled due to undeclared milk in MCT powder used in manufacturing. Milk is not declared on the label. Product item #'s 4600-P65, 4600

A sterility assurance level of 10-6 cannot be guaranteed due to intentional fraud and data integrity issues at the contract sterilizer, Steril Milano.

Infant/Child defibrillator pads contain incorrect labeling. This could lead to a delay in therapy, or delivery of lower energy than indicated for an adult patient

The bicycles have handbrakes but no footbrakes. Federal regulations require the bicycles be equipped with both handbrakes and footbrakes. Sidewalk bicycles with handbrakes, but no footbrakes, may present a risk of injury to young children who might not be able to stop the bicycles using handbrakes only.

The brown trim of the shaving kit bags contains levels of a regulated phthalate that exceed the prohibition of specific phthalates. Banned phthalates are toxic if ingested by young children and can cause adverse health issues.

CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.

CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.

Chemical Contamination: FDA analysis found 1 lot of MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA (ethyl alcohol 70%) to be below the label claim for ethanol content and to contain methanol.

Chemical Contamination: FDA analysis found 1 lot of MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA (ethyl alcohol 70%) to be below the label claim for ethanol content and to contain methanol.

CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.

If the seat is installed with only the lap belt, the child has an increased risk of injury in the event of a crash.

The storage tray with cup holders and step can come loose from the tower, posing a fall hazard to the child.

Product contained undeclared milk, wheat, and soy.

The bicycle helmets do not comply with the U.S. CPSC federal safety standard for bicycle helmets, posing a risk of head injury.

Product Contamination

The handle of the Cutie Spoovel utensil can break off releasing small parts, posing a choking hazard for young children.

Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure Increase" and the second issue is described as "Pressure Drift (Continuous Usage).

Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure Increase" and the second issue is described as "Pressure Drift (Continuous Usage).

Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure Increase" and the second issue is described as "Pressure Drift (Continuous Usage).

Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure Increase" and the second issue is described as "Pressure Drift (Continuous Usage).

The required pre-market notifications for these new infant formulas have not been submitted to the FDA. All products are not labeled as required by 21 CFR 107 .10 and 107.20 and do not bear mandatory labeling statements in English.

The required pre-market notifications for these new infant formulas have not been submitted to the FDA. All products are not labeled as required by 21 CFR 107 .10 and 107.20 and do not bear mandatory labeling statements in English.

The required pre-market notifications for these new infant formulas have not been submitted to the FDA. All products are not labeled as required by 21 CFR 107 .10 and 107.20 and do not bear mandatory labeling statements in English.

The required pre-market notifications for these new infant formulas have not been submitted to the FDA. Some products contain less than 1 milligram of iron per 100 Calories and may not provide adequate iron for some infants, particularly infants born prematurely or with a low birth weight, had low iron levels at birth, or are at risk for becoming iron deficient due to illness. All products are not labeled as required by 21 CFR 107 .10 and 107.20 and do not bear mandatory labeling statements in English.

The required pre-market notifications for these new infant formulas have not been submitted to the FDA. All products are not labeled as required by 21 CFR 107 .10 and 107.20 and do not bear mandatory labeling statements in English.

The required pre-market notifications for these new infant formulas have not been submitted to the FDA. All products are not labeled as required by 21 CFR 107 .10 and 107.20 and do not bear mandatory labeling statements in English.