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  5. Ethicon Recalls ECHELON FLEX™ ENDOPATH® Staplers for Failure to Completely Form Staples
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Ethicon Recalls ECHELON FLEX™ ENDOPATH® Staplers for Failure to Completely Form Staples

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled Product

  • ECHELON FLEX™ ENDOPATH® Staplers:
    • 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)
  • Product Codes: EC60A, PCEE60A, PLEE60A, PSEE60A
  • Lot Numbers: See specific lot numbers in the table below
  • Manufacturing Dates: July 18, 2019 – August 3, 2019
  • Distribution Dates: August 1, 2019 – September 26, 2019
  • Devices Recalled in the U.S.: 5,733
  • Date Initiated by Firm: October 3, 2019

Device Use

The Echelon Flex Endopath staplers are sterile, single patient use devices that cut and staple internal tissue. The staplers can be used in open or in minimally-invasive surgical procedures, including gynecologic, urologic, thoracic, pediatric, and general surgeries.

Image of the ECHELON FLEX ENDOPATH Stapler

Reason for Recall

Ethicon is recalling these devices because some devices may contain an out of specification component within the jaw of the device, which could lead to malformed staples. If a problem with the staple line is not recognized or is not adequately addressed, there is a potential risk of prolonged surgery, postoperative connection (anastomotic) leak, hemorrhage, hemorrhagic shock, additional surgical intervention, or death. As of October 3, 2019, 7 serious injuries and 1 death had been reported to Ethicon for affected product codes.

Who May be Affected

  • Patients who have had or may undergo surgery involving staplers for internal use
  • Surgeons who have performed or will perform surgeries using staplers for internal use

What to Do

On October 3, 2019, Ethicon sent a letter to customers who purchased the affected staplers and provided instructions. Health care facilities, distributors, and other customers must:

  1. Examine their inventory immediately to determine if they have product subject to this recall on hand and quarantine such product(s).
  2. Remove the product subject to this voluntary recall and communicate the issue to relevant operating room or materials management personnel, or anyone else in their facility who needs to be informed.
  3. If any product subject to this recall has been forwarded to another facility, contact that facility to arrange return. Please consider including a copy of this recall letter when communicating.
  4. Have completed the Business Reply Form (BRF) confirming receipt within 3 business days of receipt of the firm's letter, even if they do not have product subject to this recall.
  5. Keep the letter visibly posted for awareness until all product subject to this recall has been returned to Stericycle. While processing their returns, please maintain a copy of this notice with the product subject to this recall and keep a copy for your records.
  6. If customers have the affected product, they are required to return unused impacted ECHELON FLEX ENDOPATH 60mm Staplers subject to this recall that are in their inventory immediately. To receive replacement product, customers must return product subject to this recall by December 31, 2019. Any non-affected product and any product returned after the date specified will not be replaced.
  7. To return product subject to this recall, photocopy the completed BRF, place it in the box with the product, and affix the pre-paid authorized shipping label included with the recall notification letter. Ethicon will pay for the shipping charges only if the authorized label is used. Extra shipping labels may be obtained by calling Stericycle at 1-866-918-8756.

In addition, the FDA's letter to health care providers on surgical staplers and staples from March 2019 includes general recommendations for surgeons.

Contact Information

If you require any assistance with returning product, please contact Stericycle at 1-866-918-8756 and reference Event #7148.

If you have additional questions regarding this recall or to report any customer complaints, please contact Ethicon Customer Support Center at 1-877-ETHICON (1-877-384-4266). The Customer Support Center is open Monday through Friday, 8:00 AM to 6:00 PM ET.

Full List of Affected Devices

PRODUCT CODE PRODUCT LOT DESCRIPTION
EC60A T9408M T94A9Z   ECHELON FLEX™ ENDOPATH® 60mm Stapler – 340mm shaft
PCEE60A T93Z9Y T9411A   ECHELON FLEX™ Powered Plus ENDOPATH® 60mm Stapler – 280mm shaft
PLEE60A T93X95 T93Z75 T93Z2W T9413Z ECHELON FLEX™ Powered Plus ENDOPATH® 60mm Stapler – 440mm shaft
T93Z1G T93Y4M T94045  
T94117 T93X17 T94087
T93Z2X T9405L T94253
PSEE60A T93Z5W T93Z5X T9405V T9405W ECHELON FLEX™ Powered Plus ENDOPATH® 60mm Stapler – 340mm shaft
T93Z3F T9401L T93Y8X  
T94008 T9400D T93Z5R

Single Unit Carton (Containing (1) Sealed Tyvek Tray)

Ethicon Echelon Flex Stapler product code placement on the far right of the carton.

Label on Single Unit Carton

Ethicon Echelon Flex Stapler product lot placement on the bottom right of the label.

Tyvek Tray (Containing (1) Echelon Flex Endopath 60mm Stapler)

Ethicon Echelon Flex Stapler Tyvek tray product lot placement on the top of the tray, to the left. Product code placement on the top of the tray, to the right.

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experience using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX to 1-800-FDA-0178.

Additional Resources