Ethicon Stapler Recall Lawsuit | 2025 Latest Updates

Ethicon Stapler Lawsuit Overview

The Ethicon stapler lawsuits involve allegations against Ethicon Inc., a subsidiary of Johnson & Johnson, regarding defective surgical staplers that have caused serious complications during medical procedures.

Primary allegations include manufacturing defects that cause staplers to misfire, fail to close completely, or malfunction during critical surgical procedures.

The FDA has documented at least 7 severe injuries, including 1 death, associated with recalled Ethicon staplers. Multiple Class I recalls have been issued for various Ethicon stapler models due to defective components that pose serious risks to patient safety.

Latest Ethicon Stapler Lawsuit Updates

• July 30, 2025 – Ethicon has issued a Class I correction affecting certain Endopath Echelon Vascular White Reload stapler cartridges after reports of the device locking during surgery, failing to staple or cut tissue properly—an issue linked to one patient death and one injury [3.]. The company notified customers in April and advised hospitals to ensure surgical staff are trained on the lockout mitigation protocol; the FDA added the correction to its most serious category in May, although this is not a recall in the traditional sense. The malfunction, which impacts approximately 678,526 cartridges currently in use, can lead to surgical delays, serious bleeding, or life‑threatening hemorrhagic shock if the device cannot be removed from tissue properly.
• November 6, 2019 – Ethicon Inc. issued a Class I Recall for its Echelon Flex Endopath Staplers due to defective components causing malformed staples or complete failure to close. The FDA reported awareness of at least 7 severe injuries, including 1 death, directly associated with these recalled devices. This recall affects multiple Echelon Flex 60 models used in endoscopic procedures [1].
• May 17, 2019 – The FDA issued a Class I Recall for approximately 92,496 Endo-Surgery endoscopic and non-endoscopic staplers with adjustable height staples manufactured by Ethicon. These devices were manufactured between March 6, 2018 and March 6, 2019, and distributed between March 15, 2018 and March 8, 2019. The recall was initiated due to various defects that significantly increase the risk of severe injury or death [2].

FDA Reports and Statistics

The FDA has classified multiple Ethicon stapler recalls as Class I, reserved for situations where there is reasonable probability that use of the product will cause serious adverse health consequences or death. Specific recall statistics include:

• 92,496 Endo-Surgery staplers recalled in May 2019
• At least 7 severe injuries documented, including 1 death
• Multiple product codes affected: CDH21A, CDH25A, CDH29A, CDH33A, ECS21A, ECS25A, ECS29A, and ECS33A
• Recalls span devices manufactured and distributed throughout 2018 and 2019

Ethicon Stapler Injuries & Side Effects

Patients who have undergone surgical procedures using defective Ethicon staplers have reported a range of serious complications and life-threatening injuries.

Serious side effects reported include:

• Death: Fatal complications resulting from stapler malfunction during critical procedures
• Sepsis: Life-threatening infection from anastomotic leaks and tissue damage
• Hemorrhagic Shock: Severe bleeding complications requiring emergency intervention
• Permanent Ostomy Requirements: Need for permanent colostomy or ileostomy bags due to irreversible damage
• Anastomotic Leaks: Failure of surgical connections leading to internal bleeding and infection
• Prolonged Surgery: Extended operative time due to stapler malfunction
• Additional Surgical Interventions: Need for revision surgeries and follow-up procedures
• Irreversible Digestive Problems: Permanent nutritional and gastrointestinal complications

Do You Qualify for an Ethicon Stapler Lawsuit?

You may qualify for an Ethicon stapler lawsuit if:

• You underwent surgery using an Ethicon stapler between 2018 and 2019
• You experienced serious complications including sepsis, anastomotic leaks, hemorrhagic shock, or required additional surgeries
• The complications required emergency medical treatment or hospitalization
• You can provide medical documentation linking your injuries to the Ethicon stapler malfunction
• You suffered permanent disabilities or ongoing health problems following the surgical procedure

Evidence Required for an Ethicon Stapler Lawsuit

To pursue a successful Ethicon stapler lawsuit, you will need:

• Complete medical records from your surgical procedure
• Documentation of the specific Ethicon stapler model used during surgery
• Records of complications, additional treatments, and follow-up care
• Evidence of the stapler malfunction or defect
• Medical expert testimony linking your injuries to the defective device
• Documentation of financial losses including medical expenses and lost wages

Damages You Can Recover

Compensation in Ethicon stapler lawsuits may include:

• Medical expenses for initial surgery and ongoing treatment
• Lost wages and reduced earning capacity
• Pain and suffering damages
• Permanent disability compensation
• Punitive damages for manufacturer negligence

Ethicon Stapler Recall Information

October 31, 2019 Recall:

• ECHELON Flex 60 Endopath Stapler, Articulating Endoscopic Linear Cutter (EC60A)
• ECHELON Flex 60 Powered Plus Compact Articulating Endoscopic Linear Cutter (PCEE60A)
• ECHELON Flex 60 Powered Plus Articulating Endoscopic Linear Cutter, 44cm Shaft Length (PLEE60A)
• ECHELON Flex 60 Powered Plus Articulating Endoscopic Linear Cutter, 34cm Shaft Length (PSEE60A)

May 17, 2019 Recall:

• 92,496 Endo-Surgery endoscopic and non-endoscopic staplers
• Product codes: CDH21A, CDH25A, CDH29A, CDH33A, ECS21A, ECS25A, ECS29A, ECS33A
• Manufactured between March 6, 2018 and March 6, 2019

Also read: Defective Surgical Stapler Claim

FAQs

1. What Are the Safety Issues That Led to the Recall of Ethicon Surgical Staplers?

The safety issues that led to the recall of Ethicon surgical staplers were primarily due to malfunctions that could cause misfiring or difficulty in firing the stapler, leading to serious complications during surgery, including tissue damage or incomplete wound closure.

2. Who Can Participate in the Ethicon Surgical Stapler Recall Lawsuit?

Patients who have suffered complications or injuries due to the use of a recalled Ethicon surgical stapler during their surgery may be eligible to join the lawsuit.

3. Has Ethicon Acknowledged Responsibility for the Issues With Their Surgical Staplers?

Ethicon has acknowledged responsibility for the issues with their surgical staplers leading to the recall, but the extent of their responsibility in individual cases is determined through the legal process in the ongoing lawsuits.

4. What Types of Procedures Used Ethicon Staplers?

Ethicon Endo-Surgery endoscopic staplers are designed for use in the gastrointestinal tract to create anastomoses during surgical procedures, including bariatric surgery, colorectal surgery, and other abdominal procedures.

5. Are These Individual Lawsuits or Class Action Cases?

Schmidt & Clark handles individual litigation rather than class action suits for Ethicon stapler cases, as individual suits typically provide better compensation for the specific damages and injuries suffered by each client.

6. What Should I Do If I Think My Surgery Used a Recalled Ethicon Stapler?

Contact your surgeon or hospital to obtain records of the specific stapler model used during your procedure, and consult with an experienced product liability attorney if you experienced complications.

7. How Long Do I Have to File a Lawsuit?

The statute of limitations varies by state but typically ranges from 2-6 years from the date you discovered your injury was related to the defective stapler.

Get a Free Ethicon Stapler Recall Lawsuit Evaluation With Our Lawyers

The Product Liability Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Ethicon stapler recall lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.

Our experienced legal team offers:

• Free, confidential consultations to evaluate your case
• No upfront costs or fees – you pay nothing unless we win
• Nationwide representation for Ethicon stapler injury cases
• Personalized attention to maximize your compensation

Free Case Evaluation: If you or a loved one was injured, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.

References:

1. https://www.moph.gov.lb/userfiles/files/Medical%20Devices/Medical%20Devices%20Recalls%202019/6-11-2019/ECHELONFLEXENDOPATHStaplers.pdf
2. https://www.medtechdive.com/news/fda-classes-jj-stapler-recall-as-high-risk-ahead-of-advisory-panel/555008/
3. https://www.medtechdive.com/news/jnj-ethicon-recalls-stapler-cartridges/754157/