Three categories of Medical Device Recalls are: Class I: A situation where there is a reasonable chance that a product will cause serious health problems or death. Class II: A situation where a product may cause a temporary or reversible health problem or where there is a slight chance that it will cause serious health problems or death. Class III: A situation where a product is not likely to cause any health problem or injury. Once classified, the FDA monitors the recall to ensure that the recall strategy has been effective. Only after the FDA is assured that a product no longer violates the law and no longer presents a health hazard, does the FDA terminate the recall.