Food, drugs, devices › Ethicon Endo-Surgery Inc
Device recall: ECHELON FLEX ENDOPATH 60mm Stapler - 340mm shaft, Product Code EC60A
Ethicon Endo-Surgery Inc (Blue Ash, OH) initiated this device recall on 3 Oct 2019; FDA lists 4 product records under event 83897, classified Class I.
FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 6% of the 968 device enforcement events initiated in 2019 carry the same class.
Status: Terminated, terminated 3 Jun 2021. Initiation: voluntary: firm initiated. Ethicon Endo-Surgery Inc has 26 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Ethicon Endo-Surgery Inc, Blue Ash, OH.
Reason for recall
"The staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed staples, which can compromise staple line integrity. If the staple line is compromised, there is a potential risk of prolonged surgery, postoperative anastomotic leak, hemorrhage, hemorrhagic shock, additional surgical intervention, or death."
Distribution
"Worldwide distribution. US Nationwide. Belgium, Brazil, Canada, Chile, Colombia, Japan, Kuwait, Saudi Arabia, and Singapore."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0200-2020 | ECHELON FLEX ENDOPATH 60mm Stapler - 340mm shaft, Product Code EC60A | 849 units | Class I | Terminated | 6 Nov 2019 |
| Z-0201-2020 | ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 280mm shaft, Product Code PCEE60A | 255 units | Class I | Terminated | 6 Nov 2019 |
| Z-0202-2020 | ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 440mm shaft, Product Code PLEE60A | 5040 units | Class I | Terminated | 6 Nov 2019 |
| Z-0203-2020 | ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 340mm shaft, Product Code PSEE60A | 2112 units | Class I | Terminated | 6 Nov 2019 |
Context
Other enforcement events for Ethicon Endo-Surgery Inc
All 26 events for Ethicon Endo-Surgery Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed staples, which can compromise staple line integrity. If the staple line is compromised, there is a potential risk of prolonged surgery, postoperative anastomotic leak, hemorrhage, hemorrhagic shock, additional surgical intervention, or death."
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution. US Nationwide. Belgium, Brazil, Canada, Chile, Colombia, Japan, Kuwait, Saudi Arabia, and Singapore."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 3 Jun 2021. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.