FDA Device recall Z-2326-2021
ECHELON FLEX Powered Plus Stapler-intended for transection, resection, and/or creation of anastomoses
- FDA Device
- Class II
- terminated
- Published 2021-08-25
On 2021-08-25 the FDA classified a Class II recall of ECHELON FLEX Powered Plus Stapler-intended for transection, resection, and/or creation of anastomoses by Ethicon Endo Surgery, citing mislabeled: Labeled on the package as 60mm contains 45mm devices.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2326-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-06-03 |
| Published | 2021-08-25 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ethicon Endo Surgery |
| Distribution | US |
Product
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
Reason
Mislabeled: Labeled on the package as 60mm contains 45mm devices
Identifiers
| code_info | Lot U94V47 Exp Date: July 31, 2023 GTIN: 10705036014607 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2326-2021%22
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