Surgical Stapler Lawsuit – Litigation Status

Some people who had surgery say a stapler failed during the procedure. They say it misfired, did not fire, or left a bad line of staples. They report bleeding, organ damage, infection, or death as a result.

Most claims are filed alone, one at a time, not as a group case. Ethicon and Medtronic’s Covidien unit are named most often as defendants. No court has combined the cases into one MDL yet.

If your surgery used a stapler now under an FDA recall or fix, this may matter to you. A lawyer can check your medical records and explain your options.

Latest Surgical Stapler Lawsuit Updates

The U.S. Judicial Panel on Multidistrict Litigation (JPML) keeps its own “Pending MDLs” list. The FAQ below explains how to check that list yourself.

May 5, 2026: FDA Classifies Intuitive Surgical Stapler Recall as Class I

The FDA classified a stapler recall as a Class I recall on May 5, 2026 [1]. This is the agency’s most serious kind. The recall covers Intuitive Surgical‘s 8mm SureForm 30 Gray Reload.

The reload can leave a gap in the staple line on a blood vessel. This can cause serious bleeding. As of February 23, 2026, Intuitive Surgical had reported four injuries and one death.

March 18, 2026: FDA Issues Early Alert on SureForm 30 Staplers

The FDA issued an early alert on March 18, 2026, under the same recall notice described above. Intuitive Surgical had reported a problem with its 8mm SureForm 30 Gray Reloads.

The reloads could leave an incomplete staple line on blood vessels during surgery. Intuitive Surgical told hospitals to stop using the recalled reloads. It asked them to set aside any on hand while it looked into the cause.

April 22, 2025: Ethicon Corrects Echelon Vascular Stapler Reload

Ethicon sent an urgent device correction on April 22, 2025 [2]. The notice covered its Endopath Echelon Vascular White Reload, used in vascular surgery. The device could lock up during surgery. It could then stop cutting or stapling.

The lockout was tied to one reported death and one injury. Ethicon asked surgical teams to learn how to clear a lockout safely during a live procedure.

October 8, 2021: FDA Reclassifies Surgical Staplers as Class II Devices

The FDA’s final order took effect on October 8, 2021 [3]. It moved surgical staplers for internal use into a stricter safety class, Class II. Class II devices need extra review before they reach the market.

The new rule requires makers to file for FDA review before selling a new internal stapler. The FDA said malfunctions and misuse had led to serious harm and deaths.

April 23, 2019: FDA Discloses More than 41,000 Stapler Reports

The FDA disclosed its stapler data on April 23, 2019, in a statement from its safety center [4]. It had received more than 41,000 device-problem reports between 2011 and March 2018. In all, 366 deaths were reported.

The agency proposed a stricter safety class for staplers. It cited misfiring and bad staples as the most common problems for internal-use devices.

April 11, 2019: Ethicon Recalls Curved Intraluminal Staplers

Ethicon told customers about a recall on April 11, 2019 [5]. It covered several Curved Intraluminal Stapler models in different sizes. The devices could not fully close and cut tissue as designed.

FDA records show a weak firing stroke that left staples poorly formed and washers uncut. Ethicon asked customers to set the recalled units aside. It asked them to send the units back for credit.

What Is a Surgical Stapler?

According to the FDA, surgical staplers deliver staples to tissue inside the body during surgery. They remove part of an organ (resection). They cut through and seal organs and tissue (transection). They also join structures together (anastomosis) [6].

Surgeons use these staplers during many types of internal surgery, described below. This page covers legal claims over stapler problems. It does not cover the devices’ ordinary use.

Who May Be Affected?

You may be affected if you had gastrointestinal, bariatric, thoracic, gynecologic, urologic, or pediatric surgery. Your surgeon may have used a stapler later named in an FDA recall or fix. If so, your case may matter.

Recalled or fixed models include Ethicon’s Curved Intraluminal Stapler, supplied from March 2018 to March 2019. Also included are Ethicon’s Echelon Vascular Reload and Intuitive Surgical’s SureForm 30 Gray Reload.

Medtronic‘s Covidien unit and Ethicon make the recalled and fixed devices. They face the largest share of these claims.

A legal review is the only way to know whether you have a claim. It would look at your surgery record, the device used, and what happened next.

Reported Injuries or Damages

The FDA has tracked more than 41,000 stapler reports filed between 2011 and March 2018. Among them were 366 deaths, more than 9,000 serious injuries, and more than 32,000 malfunctions.

Bad staple lines, misfiring, and failure to fire topped the FDA’s list of reported problems. These issues showed up most often over the review period.

A 2022 study looked at the FDA’s MAUDE database for bariatric surgery from 2018 through 2020 [7]. It found 883 reported events for Medtronic staplers, 353 for Ethicon, and 35 for Intuitive Surgical.

The study put the misfire rate at 0.04 percent for Medtronic and 0.02 percent for Ethicon. Its authors said stapler malfunction is rare. They said today’s powered staplers have a strong safety record.

Recall and Regulatory Background

The FDA’s 2026 recall is a Class I recall. It covers the same SureForm 30 reload from Intuitive Surgical described above. The device can leave part of a staple line unformed on a blood vessel. This raises a bleeding risk.

Ethicon’s 2025 fix addressed a lockup problem in its Echelon Vascular Reload. A 2019 action pulled several of its stapler models. The cause was a weak firing stroke. None of these steps decides what caused any one patient’s injury.

Evidence to Preserve

If you suspect a stapler malfunction caused your injury, keep these records safe and ready to share with a lawyer:

• Your hospital and operative records that name the stapler’s brand, model, and lot number, if you have them.
• The device’s box, insert, or label, if you or your family still have it.
• Photos of the device, its box, or the surgery site, taken as soon as you can.
• Records of any extra surgery, hospital stay, or follow-up care you needed later on.
• Any letters, calls, or emails with the hospital, surgeon, or device maker about the problem.
• Any safety report you or the hospital sent to the FDA about the stapler.

Filing Deadlines

State law sets the deadline for a surgical stapler claim. There is no nationwide rule. In many states, the clock starts on the day you learned of the injury. That can be later than the day of your surgery.

Missing the deadline can end a claim no matter how strong the facts are. Checking the timeline with a lawyer soon keeps your options open.

Potential Compensation

A surgical stapler claim may seek certain damages. This depends on the facts of the case. These can include medical bills, lost income, and pain and suffering. Some claims may also seek damages for a wrongful death.

Compensation amounts vary by case. Past results do not guarantee future outcomes. A lawyer can explain what potential compensation might look like in your case.

Frequently Asked Questions

How Can I Check Whether an MDL Has Been Formed for Surgical Staplers?

You can check whether an MDL has been formed for surgical staplers on the JPML’s Pending MDLs list, which names every consolidated federal case by product. The panel posts an updated list on the first business day of each month, so checking it gives the most current status.

What Companies Make the Surgical Staplers Named in These Claims?

The staplers named in these claims are made most often by Ethicon, a Johnson & Johnson company. Medtronic’s Covidien unit also makes them. Intuitive Surgical’s reloads are named in a current recall.

Which Stapler Reload Models Are Covered by the 2026 FDA Recall?

The 2026 FDA recall covers Intuitive Surgical’s 8mm SureForm 30 Gray Reload for curved-tip staplers. FDA records list the recalled parts as numbers 48230M-05 and 48230M-06. Hospitals were told to set aside any reloads on hand.

What Should I Do If My Surgery Used a Recalled Stapler?

If your surgery used a recalled stapler, you should preserve your operative and hospital records naming the device. Also keep any follow-up-care records, as listed under Evidence to Preserve above. A free legal case review can help you learn whether those records support a claim.

What Did the 2022 Surgical Stapler Study Analyze?

The 2022 study analyzed reports in the FDA’s MAUDE database, which stands for Manufacturer and User Facility Device Experience. The study explains that device makers, not surgeons, report suspected stapler problems to MAUDE voluntarily.

Can I Recover Compensation for a Surgical Stapler Injury?

Whether you can get compensation for a surgical stapler injury depends on the facts of your case. If the malfunction caused a death, a surviving family member may bring a wrongful-death claim instead. No amount or outcome is ever guaranteed.

References

1. https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/surgical-stapler-reload-recall-intuitive-surgical-removes-8mm-sureform-30-gray-reloads
2. https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/disposable-surgical-stapler-cartridge-correction-ethicon-endo-surgery-llc-issues-correction-endopath
3. https://www.federalregister.gov/documents/2021/10/08/2021-22041/general-and-plastic-surgery-devices-reclassification-of-certain-surgical-staplers
4. https://www.fda.gov/news-events/press-announcements/statement-jeffrey-shuren-md-jd-director-fdas-center-devices-and-radiological-health-new-steps-help
5. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=171790
6. https://www.fda.gov/media/123572/download
7. https://pmc.ncbi.nlm.nih.gov/articles/PMC8896815