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Surgical Staplers and Staples

Surgical staplers and staples are medical devices that doctors may use instead of sutures. They can close large wounds or incisions more quickly and cause less pain than stitches. Doctors also use them to reconnect internal organ tissues during surgery.

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Surgical staplers are generally made of plastic and loaded with a disposable cartridge of surgical staples. The staplers come in both reusable and disposable models. They resemble construction or industrial staplers and can insert and close several staples at once.

Doctors may use these devices internally to seal tissue during surgery. They are useful in minimally invasive surgery because they require only a narrow opening and can quickly cut and seal tissue and blood vessels. Medical professionals also use staplers externally to close skin under high tension, such as on the skull or the trunk of the body.

 

Potential Advantages of Using Surgical Staples Over Sutures
  • Doctors can insert them quickly.
  • Medical professionals can easily remove them with a surgical staple remover.
  • They reduce the time a patient spends in surgery and under anesthesia.
  • They’re strong.

When Do Health Care Providers Use Surgical Staplers?

Doctors frequently use surgical staplers to close incisions in the abdomen and uterus during cesarean deliveries, or C-sections, since the staples allow people to heal faster and reduce scar tissue. Surgeons may also rely on surgical staplers when removing part of an organ or cutting through organs and tissue inside the body.

Providers also use surgical staplers to connect or reconnect internal organs within an organ system. Doctors frequently use these staplers for surgeries involving the digestive tract, including the esophagus, stomach and intestines. In these operations, surgeons remove part of these tube-like structures and reconnect the remaining portions.

Caring for Surgical Staples

Patients must pay special attention to medical staples in the skin to avoid infection. A 2022 study reviewed the surgical site infection rate of wound closure using staples versus sutures in elective knee and hip arthroplasties. The researchers found a potentially higher risk of surgical site infection in patients with staples compared to sutures, especially for patients with hip replacements.

Always follow your doctor’s instructions and do not remove any dressings until it’s safe to do so. Rinse the site twice daily to keep it clean. Your doctor will tell you how and when to dress the wound to prevent infection.

When To Call Your Doctor About Surgical Staple Complications
  • Bleeding enough to soak through the bandage
  • Brown, green or yellow foul-smelling pus around the incision
  • Change in skin color around the incision
  • Cold, pale or tingling skin near the incision site
  • Difficulty moving in the area around the incision
  • Dryness, darkened skin or other changes near the site
  • Fever of 100 degrees or higher for more than four hours
  • New, severe pain
  • Swelling or redness around the incision

Removing Surgical Staples

Surgical staples usually remain in place for one to two weeks, depending on the type of surgery and the placement of the staples. In some cases, doctors may not remove internal staples. They are either absorbed or become permanent additions to hold internal tissue together.

Removing surgical staples from the skin is generally not painful, but only a health care professional should remove them. Never attempt to remove surgical staples on your own.

Removal requires a sterile setting and a specialized surgical staple remover or extractor. The device spreads one staple at a time, allowing the doctor to gently work it out of the skin.

If the wound has not completely healed, a doctor will remove every other staple, and the patient will schedule a second appointment to remove the rest.

How Surgical Staplers Work

Surgical staplers compress tissue, connecting two pieces of tissue with staggered rows of B-shaped surgical staples and, in some models, cutting away excess tissue to create a clean closure of the surgical wound.

There are various designs for different types of surgeries, with most categorized as either linear or circular.

When using linear staplers, the surgeon uses the handles at one end to close the “jaws” of the stapler at the other end over the tissue. When the surgeon fires the stapler, a row of staples binds the tissue together, and a blade cuts the tissue between the staples. The process seals the open wound to prevent bleeding.

Surgeons use linear staplers to connect tissue during minimally invasive surgeries or to remove an organ. However, surgeries involving the digestive tract from the throat to the colon often require circular staplers.

Circular staplers fire two staggered rows of staples from a circular cartridge. This circular layout allows the stapler to connect two sections of the intestine, or another tube-like structure, after surgeons remove a portion. The staples cause tissue to pinch up as rings or donuts between the staples. A built-in blade then slices off the overlaying tissue, sealing the new connection.

Surgeons watch the closed wound for about 30 seconds to make sure they have properly squeezed the tissue together and confirm that there is no bleeding.

What Are Surgical Staples Made Of?

Common materials for surgical staples include stainless steel and titanium. These are both strong metals that tend to cause few problems for patients in surgical procedures.

However, doctors frequently use plastic staples for people with metal allergies or to reduce scar tissue.

Staples made from plastic or metals don’t dissolve like many sutures, so doctors and patients must pay close attention to prevent infection.

Manufacturers also create specialized staples for reabsorption into the body using a biodegradable material called polylactic-co-glycolic acid (PLGA). Cosmetic surgeons often use PLGA staples because, like plastic staples, they result in less scarring.

Surgical Stapler Manufacturers

Medtronic and Johnson & Johnson’s Ethicon division are the two largest surgical stapler manufacturers. Together, they have an estimated market share of about 48.6% as of 2025, according to an analysis by Future Market Insights. 3M also manufactures skin staplers sold in the United States.

In 2025, the estimated global industry value for surgical staplers and staples was roughly $3.7 billion, with most sold in North America and Europe.

Surgical Stapler Manufacturers and Select Brands
Ethicon
ECHELON series, PROXIMATE series
Medtronic
Signia Stapling System, GIA series, DST series, Appose Single-Use Skin Stapler, DFS Fascia Stapler

Surgical Stapler Recalls and Injuries

Some people who have suffered serious injuries due to malfunctioning staplers have filed surgical stapler lawsuits. In addition, the U.S. Food and Drug Administration (FDA) has issued safety communications and recalls for various surgical staplers over the years.

2019 Ethicon Recall

Johnson & Johnson subsidiary Ethicon recalled 434,614 surgical staplers in April 2019 over concerns that they might not fire with enough force to completely form staples.

The FDA branded the recall as Class I, the agency’s most serious type. The FDA warned in a statement that the devices could cause serious injuries or death.

The recall affected the company’s Curved Intraluminal Staplers used in gastrointestinal tract surgeries.

Ethicon Endo-Surgery Intraluminal Staplers
Ethicon began recalling nearly 435,000 Curved Intraluminal Staplers on April 11, 2019.

Ethicon reported that two patients had been injured by the devices, according to the FDA. In both cases, the devices misfired, cutting portions of the rectum. Misfires or other malfunctions can prolong operations or require doctors to perform unplanned surgery to correct the damage.

The FDA warned that the misfires could increase complications from surgical staplers, including the risk for bleeding, infection and permanent organ damage.

2015 Ethicon Recall

Previously, in 2015, Ethicon recalled 6,744 reload cartridges for its Echelon Endopath devices. Ethicon manufactured these devices for use in gynecologic, urologic, thoracic, pediatric and general minimally invasive surgeries.

The company reported that an inspection had found the surgical staplers’ cartridges may not insert a complete line of staples when fired.

2018 and 2019 Medtronic Recalls

Medtronic issued two recalls of its Endo GIA staplers and staple cartridges from select production lots in 2018 and 2019. Both recalls involved possible missing components. The company said the defects could affect staple alignment and lead to serious complications.

At least five people were injured by staplers included in the 2018 recall, according to the company. The 2019 recall involved defects in staple cartridges that Medtronic spotted while performing quality tests during the manufacturing process. The company reported “no confirmed complaints” about the devices from doctors or patients.

Complications From Surgical Stapler Malfunctions

Surgical stapler and staple malfunctions have resulted in thousands of serious complications. Malfunctions can prolong surgical procedures, keeping a patient under anesthesia longer than planned, which can present additional complications.

Staple injuries may cause bodily damage that doctors can only correct through other surgical interventions.

Surgical Stapler Complications Reported To the FDA
  • Bleeding, including internal bleeding
  • Fistula formation (abnormal connections between organs and tissues)
  • Increased risk of cancer recurrence
  • Sepsis (a potentially fatal reaction to infection)
  • Tearing of internal tissues and organs

FDA Actions on Surgical Staplers

In addition to its actions on product recalls, the FDA began tightening restrictions and reporting safety concerns over surgical staplers in 2019. It issued new guidance to doctors and hospitals about properly using the staplers, took steps to reclassify certain surgical staplers from low- to moderate-risk devices and reported tens of thousands of previously unknown cases of stapler malfunctions and injuries.

The new classification would require premarket review and clearance of the devices from the FDA before manufacturers could sell them.

The FDA actions followed a series of surgical stapler problems discovered earlier in 2019. KFF Health News reported that the FDA recorded more than half of all surgical stapler malfunctions from 2011 through 2018 in a hidden system known as an “alternative summary reporting program” instead of a database accessible by the public. The hidden database included over 56,000 reports.

The FDA consolidated the two databases so the public could view all of the reports. The total number of reported surgical stapler malfunctions over the eight-year period rose from 41,000 to nearly 110,000.

Timeline of FDA Actions
  • Jan. 1, 2011 to March 31, 2018
    The FDA received over 41,000 individual medical device reports to its public database for surgical staplers and staples. The reports included 366 deaths, more than 9,000 serious injuries and more than 32,000 malfunctions.
  • March 8, 2019
    The FDA sent a letter to health care providers expressing concerns about an increasing number of adverse events associated with surgical staplers and staples.
  • April 11, 2019
    Ethicon recalled curved surgical staplers for insufficient firing and failure to completely form staples. The FDA identified the recall as Class I.
  • April 24, 2019
    The FDA issued a draft guidance to help manufacturers develop labels for surgical staplers with information about specific risks, limitations and directions for use of the device.
  • April 24, 2019
    The FDA issued a proposed order that would reclassify surgical staplers for internal use from Class I (low risk) to Class II (moderate risk) medical devices with special controls.
  • May 30, 2019
    The FDA held an open public meeting of the General and Plastic Surgery Devices Panel to discuss whether reclassifying surgical staplers for internal use as Class II medical devices would be appropriate. (The advisory panel reportedly recommended switching the devices to a higher-risk classification with additional safety requirements.)
  • May 30, 2019
    A KFF Health News report revealed that the FDA recorded over 56,000 surgical stapler malfunctions from 2011 through 2018 in a hidden database, bringing the total to 110,000 malfunctions or injuries during that time period.
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