The Food and Drug Administration (FDA) is issuing this guidance to provide labeling recommendations for surgical staplers and staples for internal use. These labeling recommendations are being issued because malfunctions and misuse associated with these devices have resulted in serious adverse events, including deaths.

FDA believes that the labeling recommendations in this guidance would help promote the safe and effective use of surgical staplers and staples for internal use by helping manufacturers develop labeling with information about specific risks, limitations, and directions for use of the device.