MedWatch Safety Alerts

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FDA MedWatch Safety Alerts

Recalled device may not deliver breathing support to the patient. A delay in treatment may potentially lead to patient injury or death.
Posted: July 2, 2015, 3:10 pm
Unapproved products may be contaminated or manufactured incorrectly, which could result in patients receiving the wrong dose, even when administered according to the labeled directions for use.
Posted: July 1, 2015, 2:40 pm
FDA investigating the safety of codeine-containing medicines to treat coughs and colds in children under 18 years because of the potential for slowed or difficult breathing.
Posted: July 1, 2015, 2:00 pm
May cause anesthesia gas to leak and could prevent the ventilator from providing breathing support if not corrected immediately.
Posted: July 1, 2015, 4:00 am
New warning added to drug label to describe risk of chemical leukoderma. chemical leukoderma, have been associated with the use of the Daytrana patch.
Posted: June 24, 2015, 4:10 pm
Reports of 12 serious patient injuries, including breathing difficulties that impacted oxygen levels in patients.
Posted: June 24, 2015, 11:50 am
FDA will update recall with new information as it becomes available.
Posted: June 22, 2015, 4:35 pm
Can cause serious adverse health issues including allergic reactions, pain, infections, or death.
Posted: June 20, 2015, 1:00 am
An interruption in electrical connection would cause the pump to stop, which could cause serious patient injury or death.
Posted: June 16, 2015, 3:55 pm
Health care professionals should continue to follow the recommendations provided in the BOXED WARNING, FDA’s most serious type of warning, and the WARNINGS AND PRECAUTIONS and INDICATIONS AND USAGE sections of the labeling.
Posted: June 16, 2015, 2:00 pm
UPDATED 06/08/2015. Recall Expanded. Administration of a sterile injectable that has foreign particulates has the potential of severe health consequences.
Posted: June 9, 2015, 12:20 am
Incorrect orientation of the patch with the rough side toward the bloodstream may increase the risk of vessel thrombosis and/or embolism. Posted 06/03/2015
Posted: June 3, 2015, 4:00 am
Risk of embolization, which can cause vision impairment, blindness, stroke and damage and/or death of the skin and underlying facial structures.
Posted: May 28, 2015, 3:10 pm
Ventilator may activate false Extended High Ppeak or Circuit Occlusion audio and visual alarms, open the safety valve and stop ventilating.
Posted: May 27, 2015, 5:00 pm
Can lead to administration of more drug than was prescribed.
Posted: May 20, 2015, 10:00 pm
High levels of blood acids called ketones may require hospitalization. Posted 05/15/2015
Posted: May 15, 2015, 3:00 pm
An unauthorized user with malicious intent could access the pump remotely and modify the dosage it delivers, which could lead to over- or under-infusion of critical therapies.
Posted: May 13, 2015, 4:00 am
Possibility of a tear on the left atrial wall during use of the device.
Posted: May 7, 2015, 4:50 pm
Administration of product with particulate matter has potential to result in inflammation, allergic reactions, or blockage of blood vessels, which may be life-threatening if vital organs are affected.
Posted: May 5, 2015, 12:20 pm