Baby and kids' product recalls

Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy

Firm was notified by supplier that Organic Ground Flaxseed powder was under recall by manufacturer due to unapproved herbicide - Haloxyfop

Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.

Marketed without an Approved NDA/ANDA: Product contains undeclared sildenafil which was discovered through FDA analysis.

The baby walkers fail to meet the federal safety standard. Specifically, they can fit through a standard doorway and are not designed to stop at the edge of a step as required by the federal safety standard and they have leg openings that allow the child to slip down until the child's head can become entrapped at the neck. Babies using these walkers can be seriously injured or killed.

The boots' sole contain levels of lead that exceed the federal lead content ban. Lead is toxic if ingested by young children and can cause adverse health issues.

The products contains the substance methyl salicylate 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 tool belt, hammer and suspenders (model H3044) contain excessive levels of lead, violating the federal lead content standard. In addition, the toy goggles and hardhats do not meet toy safety requirements.

The plastic brackets on the car seat adapter can break, posing a fall hazard to infants.

The product contains the substance methyl salicylate which must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the product is not child resistant, posing a risk of poisoning if the contents are swallowed by young children.

The packaging is not child resistant as required by the Poison Prevention Packaging Act. The pain relieving cream contains lidocaine, posing a risk of poisoning to young children if they put it on their skin or ingest it.

The product contains the substance methyl salicylate which must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the product is not child resistant, posing a risk of poisoning if the contents are swallowed by young children.

The product contains sodium hydroxide. The label on the product violates the Federal Hazardous Substance Act (FHSA) by omitting the word "poison" for poisonous chemicals and the mandatory hazard statement on the front on the packaging.

The products contain sodium hydroxide or potassium hydroxide 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 chemical burns and irritation to the skin and eyes. In addition, the label on the product violates the Federal Hazardous Substance Act (FHSA) by omitting the word "poison" for poisonous chemicals and the mandatory hazard statement on the front on the packaging.

The products contain sodium and/or potassium hydroxide 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 chemical burns and irritation to the skin and eyes.

The prescription drug packaging is not child resistant as required by the Poison Prevention Packaging Act (PPPA), posing a risk of poisoning if the contents are swallowed by young children.

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

The manufacturer received complaints that customers were attempting to install the fitting software using the supplied USB drive, an error message was received, and installation failed. The failed installation has not impact to the current version of the software, and users are able to continue programming devices with the current software version.

Observed leakage at the sample port assembly which could potentially lead to loss of perfusion solution needed to maintain continuous machine perfusion.

It has been determined that the wheels on the baby scale cart can unexpectedly loosen and in the worst case, detach from the cart completely. If this occurs the cart can become unstable and tip over, potentially leading to the scale falling from the cart. If a baby is left unattended in a cart, the baby could fall off the scale and be subjected to several serious injuries.

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

The recalled chest is unstable if it is not anchored to the wall, posing tip-over and entrapment hazards that may result in death or serious injuries to children. Additionally, KULLEN 3-drawer chests imported after August 12, 2019 do not comply with the performance requirements of the updated version of the U.S. consensus standard (ASTM 2057-19).

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

The shopping cart's basket can break into sharp pieces, posing a laceration hazard.

The recalled chest is unstable if it is not anchored to the wall, posing serious tip-over and entrapment hazards that can result in death or injuries to children. The chest does not comply with the performance requirements of the U.S. voluntary industry standard (ASTM 2057-17).

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

Infant fatalities have been reported with other manufacturers' inclined sleep products, after the infants rolled from their back to their stomach or side, or under other circumstances.

Due to a complaint received and internal investigation it was determined that implant vials were distributed with incorrect color coded vials and caps. The part/lot numbers were correct, the customer received the product they ordered, however the color on the vial label and cap labels were incorrect.Specifically, the color coded vial and cap does not match the implant size described on the vial. As a result of the incorrect color on the vial and cap, the surgeon may not be certain if the implant received was the correct size. This could result in a delay in surgery, risk of infection if the surgical site has to be closed up and a second round of anesthesia.

FridaBaby has been made aware through customer reports that the product is being used outside of the labeled directions. Specifically, repeated chewing or biting on the SmileFrida, the ToothHugger has caused deterioration in the outer layer of the brush and in very rare occasions, may cause the hard plastic brush head to break, exposing a small metal piece welded inside the brush head.

Incorrect ingredient label was put on salad product and does not declare eggs and wheat.