New and strengthened WARNINGS and CONTRAINDICATIONS on drug labels describing serious risks, including slowed or difficult breathing and death.
Use of these products may pose a threat to consumers because the undeclared ingredients may interact with nitrates found in some prescription drugs and may lower blood pressure to dangerous levels.
Updated 04/13/2017. Homeopathic teething products containing belladonna pose an unnecessary risk to infants and children.
If left untreated, under-drainage can potentially lead to coma and death.
Voluntary recall of all lots of sterile products, to the hospital/user level.
Potential for ventilator reset during normal operation, without an accompanying alarm.