A recall means that the FDA and/or a manufacturer is aware of a problem with a device that could affect patient safety and health. Most manufacturers voluntarily recall medical devices that are found to have created health risks, but the FDA has the right under law to issue the recall if the company does not do so, or refuses to do so, which is rare. The recall may be related to a correction on a device or total removal of the device from the market.
The FDA splits its product recalls into three classes:
• Class I: This is the most serious type of recall. There is a reasonable probability that the product will cause serious adverse events or death;
• Class II: The majority of recalls fall in this category. Products under a Class II recall can cause temporary or reversible adverse events. Injuries from such devices can still be serious, but are not typically life-threatening;
• Class III: These products are not as likely to cause injuries or illness, but that violate FDA regulations;
References : Drug And Device Watch, USFDA, Drug Watch, Herrman & Herrman