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# Ethicon Echelon Flex Stapler Recall is Class 1
- URL: https://www.fdaweb.com/ethicon-echelon-flex-stapler-recall-is-class-1/
- Published: 2019-10-30T12:00:00.000Z
- Updated: 2026-09-15T01:59:48.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5145382

FDA says an Ethicon 10/3 recall 8,256 of its Echelon Flex Endopath staplers due to a failure to completely form staples is a Class 1 recall. The company [says](https://www.fda.gov/medical-devices/medical-device-recalls/ethicon-recalls-echelon-flextm-endopathr-staplers-failure-completely-form-staples?utm%5Fcampaign=FDA%20MedWatch~ECHELON%20FLEX%20ENDOPATH%20Staplers%20by&utm%5Fmedium=email&utm%5Fsource=Eloqua) it recalled the devices because some of them may contain an out-of-specification component within the device jaw that could lead to malformed staples. If a problem with the staple line is not recognized or is not adequately addressed, Ethicon says, there is a potential risk of prolonged surgery, postoperative anastomotic leak, hemorrhage, hemorrhagic shock, additional surgical intervention, or death.

An FDA [notice](http://s2027422842.t.en25.com/e/es?s=2027422842&e=270254&elqTrackId=376c7bc788024cd5a73d955f2e3dcbdc&elq=28881f790b8e4bc59e18d494172a39ce&elqaid=10054&elqat=1&ref=fdaweb.com) says that as of 10/3, seven serious injuries and one death had been reported to Ethicon.

The staplers may be used in open and minimally invasive surgical procedures including gynecologic, urologic, thoracic, pediatric, and general surgeries, FDA says.