ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler — Class I medical device recall Z-0201-2020
Terminated recall by Ethicon Endo-Surgery Inc, reported 2019-11-06, distributed nationwide. The staplers may contain an out of specification anvil component within the jaw of the device. This condition
| Recall number | Z-0201-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ethicon Endo-Surgery Inc, Blue Ash, OH, United States |
| Recall initiated | 2019-10-03 |
| Classified | 2019-10-29 |
| Reported by FDA | 2019-11-06 |
| Terminated | 2021-06-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, BR, CA, CL, CO, JP, KW, SA, SG |
| Quantity | 255 units |
| Reason classes | specification failure, packaging |
| Lot numbers | T93Z9Y, T9411A |
Product
ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 280mm shaft, Product Code PCEE60A
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.
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-0201-2020. 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.