Baby and kids' product recalls

Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.

The crib mattresses fail to meet the federal open flame standard for mattresses, posing a fire hazard.

Product Contamination

Misbranding

The sweatshirts have a drawstring around the neck area which poses a strangulation hazard to children. Drawstrings can become entangled or caught on playground slides, hand rails, school bus doors or other moving objects, posing a significant strangulation and/or entanglement hazard to children.

The trigger spray assembly can be removed from the De-Icer and Frost Shield container. The product contains methanol and ethylene glycol. Children may gain access to the product by removing the trigger assembly, posing a risk of poisoning.

customers are receiving a high number of Abnormal Assay Errors or are not able to calibrate B2MIC when using Flex reagent cartridge B2MIC various lots. In failure mode, there is the potential for falsely depressed beta2-Microglobulin results on the Dimension Vista system due to assay reagent contamination.

Infant Heel warmers may break during activation resulting in spillage of the contents on patients or healthcare worker causing potential skin/eye irritations

Infant Heel warmers may break during activation resulting in spillage of the contents on patients or healthcare worker causing potential skin/eye irritations

The Moses basket fails to meet the federal hand-held infant carrier standard and the stand fails to meet the bassinet/cradle standard. The basket can slide off an inclined surface and the stand can tip, posing a fall hazard for infants.

The red paint on the zipper contains excessive levels of lead, violating the federal lead paint standard.

Mislabeling

Product Contamination

Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.

Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.

Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.

Listeria contamination due to various GMP violations. possible.

Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared diclofenac, a prescription non-steroidal anti-inflammatory drug, and chlorpheniramine, an over-the-counter antihistimine, making this an unapproved drug.

The possibility exists for intraoperative reamer head breakages which could also allow for un-retrieved fragments of non-implant grade material: additional lot numbers identified. No new adverse events reported.

Complaints received of the front joint of the spring arm AC 2000 could break at the interface to the monitor.

Complaints received of the front joint of the spring arm AC 2000 could break at the interface to the monitor.

Complaints received of the front joint of the spring arm AC 2000 could break at the interface to the monitor.

Complaints received of the front joint of the spring arm AC 2000 could break at the interface to the monitor.

Complaints received of the front joint of the spring arm AC 2000 could break at the interface to the monitor.

Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.

Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.

Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.

The bottle cap can be cracked which can cause the child-resistant closure to become ineffective to young children who can gain unintended access to the capsules, posing a risk of poisoning.

The nightlight's plastic covering can detach and expose electrical components, posing an electrical shock hazard.

Product Contamination