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Medical Device Safety
FDA's Resource for Health Care Professionals on Device Recalls, Alerts, and other Safety Information

Advice for Patients

Recall of Icy Hot Heat Therapy Patches: Burns and Skin Irritations (02/25/2008)

Chattem, Inc. is recalling Icy Hot Heat Therapy Air Activated Heat patches due to reports of first, second and third degree burns, as well as skin irritation and skin removal. These products are adhesive patches that generate heat when exposed to the air. Consumers who have the recalled patches should stop using them immediately and discard or return them.

Advice for Patients: Denture Cleansers (02/14/2008)

FDA has received reports of severe patient reactions linked to denture cleansers, including at least one death. The most likely cause is the ingredient persulfate, which is known to cause allergic reactions. Recommendations on how to recognize and avoid these reactions are provided.

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Information on Mortality Rates with the AneuRx® Stent Graft System

In a recent Public Health Notification, FDA informed healthcare professionals about new data on mortality rates associated with the AneuRx® Stent Graft System. This endovascular graft, made by Medtronic, is used as an alternative to open surgery in preventing the rupture of abdominal aortic aneurysms (AAA)...

Choosing the Correct Test Strip for a Blood Glucose Meter

FDA is aware of cases where patients have used LifeScan OneTouch Ultra test strips with their Abbott Precision Xtra blood glucose meters. As a result, the meters recorded lower-than-expected blood glucose levels, which can have serious clinical consequences...

Updated May 6, 2008