|Date||Brand Name||Product Description||Reason/ Problem||Company||Details / Photo||Recall Type|
|03/04/2014||HeartMate II||HeartMate II LVAS Pocket System Controller||Difficulties encountered when changing from a primary system controller to a backup system controller||Thoratec Corporation||454, 230|
|01/29/2014||Greatbatch, Inc.||Standard Offset Cup Impactors||Sterilization recommendation in the Instructions for Use for the product did not meet requirements for sterility assurance||Greatbatch, Inc.||454, 230|
|01/21/2014||TRUFILL®||TRUFILL® n-BCA Liquid Embolic System||Incorrect statement in the package Instructions for Use||Codman Neuro||454, 230|
|01/20/2014||t:slim||Insulin Cartridges||Cartridges may be at risk for leaking||Tandem Diabetes Care, Inc.||454, 230, 509|
The list above provides information gathered from press releases and other public notices about certain recalls of FDA-regulated products.
Press releases issued more than 60 days ago are accessible in the Recall and Safety Alerts Archive. For more safety information in a specific product area, please visit the links below.
Recalls of raw (fresh and fresh frozen) oysters, clams, mussels, and whole and roe-on scallops
The safety of these products is ensured by the Interstate Shellfish Sanitation Conference (ISSC), which consists of federal, state, and industry partners who administer the National Shellfish Sanitation Program (NSSP).