Consumer Product Recalls

Hazard: Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet

Hazard: Marketed without an Approved NDA/ANDA; FDA laboratory analysis confirmed product tainted with undeclared metformin and glyburide

Hazard: CGMP Deviations; product intended for quarantine was inadvertently distributed

Hazard: CGMP Deviations: lack of adequate release testing.

Hazard: Inoperative hazard lights cannot alert other drivers as intended. In addition, the inability to adjust the brightness on the instrument panel display can make it difficult to see critical safety information or distract the driver. Both scenarios can increase the risk of a crash.

Hazard: A deactivated driver's air bag will not deploy as intended, increasing the risk of injury during a crash.

Hazard: An inoperative forward collision warning system that does not function as intended can increase the risk of a crash.

Hazard: A fuel leak in the presence of an ignition source increases the risk of a fire. An engine stall increases the risk of a crash.

Hazard: A loss of drive power increases the risk of a crash.

Hazard: A detached fastener can become a road hazard, increasing the risk of a crash.

Hazard: Referencing an incorrect label may lead to unintentionally overloading the vehicle, increasing the risk of a crash.

Hazard: A sudden loss of the rear brakes increases the risk of a crash or injury.

Hazard: A loss of vehicle stability increases the risk of a crash.

Hazard: A rearview camera that does not display an image can reduce the driver's rear view, increasing the risk of a crash.

Hazard: An engine stall or loss of power can increase the risk of a crash or injury.

Hazard: Driving without a functioning anti-lock brake system may result in the trailer not braking as intended, increasing the risk of a crash.

Hazard: An inverted cooktop flame increases the risk of injury or fire.

Hazard: The handheld hair dryer brushes lack an immersion protection device, posing an electrocution or shock hazard to consumers if the hair dryer brushes fall into water when plugged in. The CPSC has determined that hair dryers not equipped with the integral immersion protection present a substantial product hazard.

Hazard: The recalled roller shades have long operating cords that pose strangulation and entanglement hazards to children, in violation of the federal regulations for window coverings. The shades also violate labeling requirements for window coverings.

Hazard: The locking mechanism on the folding knives can fail, posing a laceration hazard to the user.

Hazard: The helmets do not comply with the positional stability, impact, labeling and certification requirements of the mandatory federal safety regulation for bicycle helmets. The helmets can fail to protect the wearer in the event of a crash, posing a risk of head injury.

Hazard: The recalled children's pajamas violate the flammability regulations for children's sleepwear, posing a risk of burn injuries to children.

Hazard: Potential for distal tip tearing of the Mechanical Lithotriptor V.

Hazard: Platelet Reactivity Test distributed without appropriate US-FDA market clearance; if used healthcare personnel could use the baseline PRUTest measurement prior to initiating drug therapy, and then use the percent inhibition formula in the notice to manually calculate the percentage of platelet aggregation inhibition for a given patient receiving drug treatment with P2Y12 receptor inhibitor.

Hazard: Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s).

Hazard: Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s).

Hazard: Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s).

Hazard: During the set-up and workflow to begin Vios monitoring, it has been noticed that patient vital signs and ECG waveforms can become distorted and will flicker or flash very fast. This issue only occurs on the Central Station Monitor (CSM) in the patient tiles view and is not seen at any other point during patient monitoring & not on the Bedside Monitor.

Hazard: Incorrect expiration date listed on the outer box, which does not align with the correct expiration date listed on the inner tray.

Hazard: Reports of various packaging issues that may result in a breach of the sterile barrier.