Framingham, Mass. — HeartWare International, Inc. (Nasdaq: HTWR), is issuing a voluntary Urgent Medical Device Recall in the United States related to older HeartWare® Ventricular Assist System Controllers, which were distributed in the U.S. during the clinical trial period prior to Food and Drug Administration (FDA) approval in 2012.
Englewood Cliffs, NJ — Unilever United States, Inc. is voluntarily recalling a limited number of tubs of Breyers® No Sugar Added Salted Caramel Swirl because they may inadvertently contain almonds, which are not listed as an ingredient on the label. Persons who have an allergy or severe sensitivity to almond run the risk of a serious or life-threatening allergic reaction if they consume this product.
Tandem Diabetes Care®, Inc. or Tandem, today announced that it is expanding a voluntary recall of specific lots of insulin cartridges that are used with the t:slim® Insulin Pump. The affected cartridges may be at risk for leaking. This could potentially result in the device delivering too much or too little insulin, which can lead to a serious adverse event.