Written and maintained by CASRAI Editorial Board
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This page describes products and general use; it is not medical advice.
A surgical stapler is a single-purpose device that places metal staples in tissue. The first question that sorts them is where the staples go: inside the body during an operation (internal use) or onto the skin or scalp (external use). Within internal use, the product names in FDA’s labeling guidance split mainly by cartridge shape and whether the device cuts. Who uses them: surgeons and operating-room teams (internal staplers), and clinicians who close skin wounds (external staplers). Buyers and supply staff meet them as devices plus matching staple cartridges or reloads.
What a surgical stapler is
FDA describes two broad uses. Internal-use staplers deliver staples inside the body for resection, transection and creating anastomoses. External-use staplers close large wounds or surgical cuts on the skin or scalp. FDA’s labeling guidance calls internal staplers specialized prescription devices that deliver compatible staples to internal tissues, with uses that include gastrointestinal, gynecologic and thoracic surgery.
In October 2021 FDA issued a final order reclassifying internal-use surgical staplers from Class I to Class II, which brings special controls and 510(k) premarket notification (86 FR 56195, October 8, 2021). The same month FDA finalized labeling recommendations for them. Both documents are listed under Sources. See also the guide to sutures for how staples compare with thread-based closure.
Surgical stapler types
Staplers can be grouped in more than one way, so the table below follows the device classes named in FDA’s labeling guidance and the external-use description on FDA’s staplers page.
| Type | Typical use | Key difference |
|---|---|---|
| Linear cutting stapler (manual or powered; open or endoscopic) | Internal use | Package label items include cartridge size, shaft length, tissue gap or jaw opening, articulation angles, staple rows and pattern, and maximum reloads |
| Transverse approximator, non-cutting (open) | Internal use | Named in FDA guidance as a separate non-cutting open stapler class |
| Circular stapler (manual or powered; open or endoscopic) | Internal use | Cartridge size is a diameter; the label should state how many counterclockwise knob turns remove the device after firing |
| External (skin) stapler | Closing large wounds or surgical cuts on skin or scalp | External use rather than internal; FDA’s page does not list further specifications |
Robotic staplers are noted separately in the guidance, and staples, reloads and cartridges are covered as their own product items.
Specifications on the package label
FDA’s guidance lists the parameters a label should let a user read before choosing or using an internal stapler. These are recommendations (the guidance is nonbinding), but they are a useful checklist when comparing product listings or instructions for use.
| Specification | Linear cutting | Circular |
|---|---|---|
| Cartridge color with open and closed staple heights and intended tissues | Yes | Yes |
| Cartridge size | Yes | Yes (diameter) |
| Staple rows and staple pattern | Yes | Yes |
| Pre-fire compression time | Yes | Yes |
| Tissue-thickness safety mechanism and ready-to-fire indicator | Yes | Yes |
| Shaft length, tissue gap or jaw opening, articulation angles | Yes | Not listed |
| Maximum reloads, incremental firings, compatible trocar sizes | Yes | Not listed |
| Knob turns counterclockwise to remove after firing | Not listed | Yes |
The guidance also recommends stating maximum and minimum tissue thickness for each staple type, maximum consecutive firings, compatible staple models, and compatibility with staple-line reinforcement. Cartridge colors are not a universal code: the guidance’s sample label (a hypothetical device) assigns blue, white and green to different open and closed staple heights, and that table is an illustration, not a standard.
How to choose
The criteria that FDA states are about matching the product to its labeling, not about brand or price:
- Confirm the labeled tissues of intended use for the stapler and the cartridge.
- Confirm the labeled minimum and maximum tissue thickness for each staple type. FDA’s recommended warning is not to staple tissue outside those limits.
- Confirm that cartridges, reloads and any staple-line reinforcement are listed as compatible with the stapler model.
- Check that the label gives the parameters in the table above, because FDA notes that misuse can be made worse by inadequate instructions for use.
Safe use basics and how to use a surgical stapler
Surgical staplers are prescription devices used by trained clinicians. This page does not give step-by-step operating instructions; the manufacturer’s instructions for use and clinical training govern how a particular model is loaded and fired. One general point from FDA’s recommended labeling: users should visually inspect for unintended structures or obstructions before firing.
FDA reports that from January 2011 to March 2018 it received over 41,000 adverse event reports and over 360 deaths involving internal staplers and staples. Reported problems include the staple line opening or staples forming incorrectly, misfiring, difficulty firing, failure to fire, and staples applied to the wrong tissue or in the wrong size. FDA states that both device misuse and device malfunction are root causes. User facilities must report deaths and serious injuries to FDA (see Medical Device Reporting), and problems can also be reported through MedWatch.
Surgical stapler uses
Internal staplers are used for resection, transection and anastomoses, including in gastrointestinal, gynecologic and thoracic surgery. External staplers close large skin or scalp wounds and surgical cuts. For how skin staplers appear on a clinic supply list, see the dermatology office supply checklist. Surgeon-preferred stapler lines are one example in physician preference items.
Common mistakes
These are the failure patterns FDA names, not a list of individual blame:
- Using a cartridge or staple size that does not suit the thickness of the tissue involved.
- Stapling outside the labeled maximum or minimum tissue thickness.
- Treating cartridge colors as universal rather than reading the labeled staple heights and intended tissues.
- Working from inadequate instructions for use, which FDA says can worsen misuse.
FAQ
What are the main types of surgical staplers?
FDA’s guidance names manual and powered linear cutting staplers, non-cutting transverse approximators, and manual and powered circular staplers, in open and endoscopic forms, plus staples, reloads and cartridges. Skin staplers are the external-use type.
How do you use a surgical stapler?
By following the manufacturer’s instructions for use and clinical training for that model. General points from FDA are to stay within the labeled tissue thickness limits and to inspect before firing. This page is not a procedure guide.
What are surgical staplers used for?
Internal staplers resect, transect and create anastomoses; external staplers close skin or scalp wounds.
Sources
- U.S. Food and Drug Administration, “Surgical Staplers and Staples” (page current as of October 7, 2021; checked October 29, 2026): https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/surgical-staplers-and-staples.
- U.S. Food and Drug Administration, “Surgical Staplers and Staples for Internal Use – Labeling Recommendations,” final guidance, October 2021, Docket FDA-2019-D-1262 (checked October 29, 2026): https://www.fda.gov/media/123572/download.
