Endopath Echelon Vascular White Reload for Advanced Placement Tip — Class I medical device recall Z-1746-2025
Ongoing recall by Ethicon Endo-Surgery Inc, reported 2025-05-28, distributed nationwide. Firm has received an increase in reports regarding inadvertent instrument lockout during surgical procedures i
| Recall number | Z-1746-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ethicon Endo-Surgery Inc, Blue Ash, OH, United States |
| Recall initiated | 2025-04-22 |
| Classified | 2025-05-20 |
| Reported by FDA | 2025-05-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 678,526 |
| UPC / GTIN / UDI-DI | 10705036014591 |
| Lot numbers | 112D03, 125D04, 134D80, 155D33, 159D49, 167D13, 175D72, 181D11, 194D76, 194D77, 214D17, 223D59, 234D11, 238D70, 261D10, 270D69, 317D73, 317D74, 319D76, 326D66, 336D39, 338D99, 347D73, 349D54, 356D53, 356D54, 367D26, 378D04, 379D80, 400D82, 413D56, 415D43, 418D41, 419D47, 427D07, 434D35, 442D78, 442D83, 444D96, 455D03 and 17 more |
Product
Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR35
Reason for recall
Firm has received an increase in reports regarding inadvertent instrument lockout during surgical procedures involving the device. If lockout occurs, the device will momentarily activate but will not cut or staple tissue, and additional steps will be required to open it and remove it from tissue. If user is unable to remove the device from the tissue, potential harms to patient include surgical delay, bleeding/hemorrhage, life threatening hemorrhage/hemorrhagic shock, and conversion to open therapy. Two adverse events received, including one patient 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-1746-2025. 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.