Class I — Ethicon Endo-Surgery Inc
| Recalling firm | ETHICON ENDO-SURGERY, INC. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Ongoing |
| Reason | 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. |
| Product | Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR35 |
| Quantity | 678,526 |
| Distribution | US distribution nationwide. OUS distribution to EMEA, LATAM, APAC, and Canada. |
| Initiated | 2025-04-22 |
| Classified | 2025-05-20 |
| Recall number | Z-1746-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Ethicon Endo-Surgery Inc (Z-1746-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96750/
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