ECHELON FLEX Powered Plus Stapler-intended for transection — Class II medical device recall Z-2326-2021
Terminated recall by Ethicon Endo-Surgery Inc, reported 2021-08-25, distributed nationwide. Mislabeled: Labeled on the package as 60mm contains 45mm devices
| Recall number | Z-2326-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ethicon Endo-Surgery Inc, Blue Ash, OH, United States |
| Recall initiated | 2021-06-03 |
| Classified | 2021-08-19 |
| Reported by FDA | 2021-08-25 |
| Terminated | 2022-09-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CH, CN, DE, DK, EE, ES, FR, GB, IT, JP, KR, LT, LV, NL, PL, PT, RU, SE |
| Quantity | 763 eaches |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 10705036014607 |
| Lot numbers | U94V47 |
| Expiration dates | 2023-07-31 |
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 for recall
Mislabeled: Labeled on the package as 60mm contains 45mm devices
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2326-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.