I have had the privilage to lead the root cause investigations on two recalls in the market. The first recall was regarding a mislabeled lot of product. The lot was inadvertently labeled as a different model number that looks similar. The root cause investigation for this recall indicated that the packaging material for both models were not controlled in storage and there was no clear identification in the SOP to instruct the operator of which packaging material is to use with different models. The second recall I worked on was a product that was not packaged properly, which have led the company to believe that the integrity of the product may have been compromized. Therefore, the organization decided to recall these products to ensure patient safety.