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FDA MedWatch Safety Alerts
Lifesaver Single Patient Use Manual Resuscitator by Teleflex Hudson RCI: Class I Recall - Intake Port Blockage
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 Prescription Ear Drop (Otic) Products: Not FDA Evaluated for Safety, Effectiveness and Quality
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
Codeine Cough-and-Cold Medicines in Children: Drug Safety Communication - FDA Evaluating Potential Risk of Serious Side Effects
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
FLOW-i Anesthesia Systems by Maquet: Class I Recall - Dislodged Patient Cassette May Stop Patient Ventilation
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
Daytrana Patch (methylphenidate transdermal system): Drug Safety Communication - Permanent Skin Color Changes
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
Covidien Shiley Neonatal and Pediatric Tracheostomy Tubes by Medtronic: Recall - Tubes Formed With Wider-angle Bend Than Standard Models
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
M/L Taper with Kinectiv Technology Prosthesis by Zimmer: Class I Recall - Higher than Expected Levels of Manufacturing Residues
Can cause serious adverse health issues including allergic reactions, pain, infections, or death.
Posted: June 20, 2015, 1:00 am
HeartWare Ventricular Assist System: Class I Recall - Damaged Alignment Guides or Connection Pins May Cause Pump to Stop
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
Potiga (ezogabine): Drug Safety Communication - FDA Determines 2013 Labeling Adequate to Manage Risks of Retinal Abnormalities, Potential Vision Loss, and Skin Discoloration
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
Vascu-Guard Peripheral Vascular Patch by Baxter: Recall - Difficulty Distinguishing the Smooth from Rough Surface
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
Unintentional Injection of Soft Tissue Filler into Blood Vessels in the Face: FDA Safety Communication - Risk of Serious Patient Injury
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
Zerbaxa (ceftolozane and tazobactam): Drug Safety Communication - FDA Cautions About Dose Confusion and Medication Errors
Can lead to administration of more drug than was prescribed.
Posted: May 20, 2015, 10:00 pm
SGLT2 inhibitors: Drug Safety Communication - FDA Warns Medicines May Result in a Serious Condition of Too Much Acid in the Blood
High levels of blood acids called ketones may require hospitalization. Posted 05/15/2015
Posted: May 15, 2015, 3:00 pm
Testosterone Products: Drug Safety Communication - FDA Cautions About Using Testosterone Products for Low Testosterone Due to Aging; Requires Labeling Change to Inform of Possible Increased Risk of Heart Attack And Stroke
UPDATED 05/15/2015. Testosterone product labels updated.
Posted: May 15, 2015, 2:50 pm
LifeCare PCA3 and PCA5 Infusion Pump Systems by Hospira: FDA Safety Communication - Security Vulnerabilities
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
Tiger Paw System II by Maquet Medical Systems: Class I Recall - May Cause Tears and Bleeding in Heart Tissue
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