Baby and kids' product recalls

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 products is not child resistant, posing a risk of poisoning if the contents are swallowed by young children.

The bunny basket's eyes can detach, posing a choking hazard to young children.

Product Contamination

The toy's rolling cylinder can separate, exposing the balls inside, posing a choking hazard to children.

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

The device was being marketed as an IVD without a 510(k). Therefore, performance characteristics of these breast milk analyzers have not been adequately validated. An erroneous result could lead to sub-optimal nutrition supplementation for patients (infants)

The products contain the substance lidocaine 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 or placed on the skin of young children.

Due to a manufacturing issue, small parts from the products can come loose, posing a choking hazard to young children.

The products are dietary supplements containing iron 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.

There is a potential for AED pads to experience gel separation from the foam/tin backing when peeled from the plastic liner. The gel may fold onto itself resulting in reduced surface area or gel on the pad, or it may separate almost completely leaving only a small amount of gel on the pad.

Cybersecurity Improvement Action-not equipped against potential cyber security threats

may be contaminated with Listeria monocytogenes

may be contaminated with Listeria monocytogenes

may be contaminated with Listeria monocytogenes

may be contaminated with Listeria monocytogenes

Loose pieces of foam can present a choking hazard to a child, increasing the risk of injury.

The product contains sodium 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 Substances Act (FHSA) by omitting the mandatory information on the packaging.

The white plastic seat can break, posing fall and injury hazards to children.

Siemens Healthineers has identified a software error in previous software version VB10 for the Ysio fully automated system. The unit may process incorrect internal values for the position of its ceiling tube stand. If the user activates a longitudinal or transversal movement at the time of the error, the system controls may initiate a correction of the tube stand position, resulting in an unintended movement. If the described error occurs, a potential for collision risk for objects or persons in the vicinity of the moving stand exists. This may result in minor to serious injuries to persons.

Lack of sterility assurance.

Lack of sterility assurance.

Lack of sterility assurance.

Lack of sterility assurance.

Lack of sterility assurance.

Lack of sterility assurance.

Lack of sterility assurance.

Lack of sterility assurance.

The rattle's legs can break off, posing a choking hazard to young children.

In 2018, Philips Respironics added foam replacement to the preventive maintenance schedule for these devices after discovering the polyester-based polyurethane (PE-PUR) foam may degrade into particles. This 2018 correction has been superseded by the device removal and rework described in Philips Respironics 2021 recall action for the same devices.

Sub Potent