Food, drugs, devices › Ethicon Endo-Surgery Inc
Device recall: ECHELON FLEX Powered Plus Stapler-intended for transection, resection, and/or creation of anastomoses. The instruments h
FDA enforcement event 88349 is a device recall by Ethicon Endo-Surgery Inc of Blue Ash, OH, initiated 3 Jun 2021 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 89% of the 900 device enforcement events initiated in 2021 carry the same class.
Status: Terminated, terminated 14 Sep 2022. 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
"Mislabeled: Labeled on the package as 60mm contains 45mm devices"
Distribution
"Worldwide distribution - US Nationwide distribution in the states of MD, WA and the countries of Belgium, China, Denmark, Estonia, France, Germany, Italy, Japan, Korea, Latvia, Lithuania,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2326-2021 | ECHELON FLEX Powered Plus Stapler-intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. Product Code: PSEE60A | 763 eaches | Class II | Terminated | 25 Aug 2021 |
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: "Mislabeled: Labeled on the package as 60mm contains 45mm devices"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution - US Nationwide distribution in the states of MD, WA and the countries of Belgium, China, Denmark, Estonia, France, Germany, Italy, Japan, Korea, Latvia, Lithuania,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 14 Sep 2022. "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.