Baby and kids' product recalls

Product may contain foreign material.

Chicago Bar Company LLC d/b/a RXBAR is voluntary recalling certain varieties of bars due to undeclared allergen peanut.

Chicago Bar Company LLC d/b/a RXBAR is voluntary recalling certain varieties of bars due to undeclared allergen peanut.

Chicago Bar Company LLC d/b/a RXBAR is voluntary recalling certain varieties of bars due to undeclared allergen peanut.

Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.

Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.

Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.

It was identified that the volume of air inside the mattress may expand in regions of high altitude which may result in an unintended gap between the plateau of the inflated patient surface and tub. A Health Hazard Evaluation was completed which identified the potential risk of patients moving out of position and rolling over on the mattress. While the highest possible severity of harm associated with this condition is death, there have been no reports of injury or harm. This condition has only presented in regions of high altitude; however, Stryker has chosen to replace all Naera mattresses in the field.

From three incidents in Denmark and Sweden, comparison studies on patient blood samples carried out for quality assurance demonstrated that creatinine measurements as determined on analyzers could be underestimated with up to 28% as compared with measurements from COBAS. The underestimated creatinine occurs specifically, when measurements on Autocheck 6+ level 1 (also known as S7835 Autocheck module and abbreviated AC6+L1) are less than or equal to 230 micro-meter of a specified insert interval for AC6+L1 with insert limits 210 290 micro-meter. Ultimately, a lower read-out on patient samples is observed Customers are concerned about underestimation of creatinine results in patients, which are to undergo radiocontrast x-ray investigations. If these patients are not healthy, the exposure of radiocontrast agents may induce kidney insufficiency (contrast-induced nephropathy). Hazardous situation: Underestimation of the concentration of creatinine.

The unicorn horn on the boot can detach, posing a choking hazard to children.

The children's ride-on Power Wheels can continue to run after the foot pedal is released, posing an injury hazard.

Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use included in the Epi-Safe Kits for the Epi-Safe Syringe (and/or the Safety Lok Syringe in Model 8600-01120) recommend a midpoint dosage of epinephrine for children between 0 lbs. and 66 lbs. of 0.15mL that has not been approved by FDA for children. Reliance on the current IFU and/or use of the Epi-Safe Syringe as instructed may result in the administration of an inappropriate dosage of epinephrine to young children experiencing anaphylaxis, especially those under 33 lbs. Additionally the Epi Safe syringe does not have the correct markings to allow a health care provider to draw up the correct dosage for children under 33 kg.

Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use included in the Epi-Safe Kits for the Epi-Safe Syringe (and/or the Safety Lok Syringe in Model 8600-01120) recommend a midpoint dosage of epinephrine for children between 0 lbs. and 66 lbs. of 0.15mL that has not been approved by FDA for children. Reliance on the current IFU and/or use of the Epi-Safe Syringe as instructed may result in the administration of an inappropriate dosage of epinephrine to young children experiencing anaphylaxis, especially those under 33 lbs. Additionally the Epi Safe syringe does not have the correct markings to allow a health care provider to draw up the correct dosage for children under 33 kg.

Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use included in the Epi-Safe Kits for the Epi-Safe Syringe (and/or the Safety Lok Syringe in Model 8600-01120) recommend a midpoint dosage of epinephrine for children between 0 lbs. and 66 lbs. of 0.15mL that has not been approved by FDA for children. Reliance on the current IFU and/or use of the Epi-Safe Syringe as instructed may result in the administration of an inappropriate dosage of epinephrine to young children experiencing anaphylaxis, especially those under 33 lbs. Additionally the Epi Safe syringe does not have the correct markings to allow a health care provider to draw up the correct dosage for children under 33 kg.

Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use included in the Epi-Safe Kits for the Epi-Safe Syringe (and/or the Safety Lok Syringe in Model 8600-01120) recommend a midpoint dosage of epinephrine for children between 0 lbs. and 66 lbs. of 0.15mL that has not been approved by FDA for children. Reliance on the current IFU and/or use of the Epi-Safe Syringe as instructed may result in the administration of an inappropriate dosage of epinephrine to young children experiencing anaphylaxis, especially those under 33 lbs. Additionally the Epi Safe syringe does not have the correct markings to allow a health care provider to draw up the correct dosage for children under 33 kg.

The bed rails fail to meet the federal mandatory standard for portable bed rails, posing entrapment and suffocation hazards to young children.

Product Contamination

Superpotent Drug: recalled lots may have higher concentration of ibuprofen.

Superpotent Drug: recalled lots may have higher concentration of ibuprofen.

Superpotent Drug: recalled lots may have higher concentration of ibuprofen.

Potential metal fragments.

The dietary supplement blister packaging is not child resistant, as required by federal law. If ingested by a child, these supplements could cause serious injury or death.

A metal grommet used to attach a fabric flap to a page in the book can detach, posing a choking hazard to young children.

The metal snaps on the snowsuit can detach, posing a choking hazard to young children.

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

a portion of a single lot was not manufactured in accordance with the internal formulation resulting in inhibited growth of Gram negative organisms.

Consumer complaints of finding foreign objects in bottles of gummy vitamins.

If the fire suppression system does not work as intended, it can increase the risk of injury in the event of a fire.

The zipper slider can detach from the hoodie, posing a choking hazard to young children.

The legs on the highchair can detach from the seat, posing fall and injury hazards to children.