FDA Device recall Z-0834-2024
ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Stapler, Endoscopic Linear Cutter Reload (+Gripping…
- FDA Device
- Class II
- ongoing
- Published 2024-02-07
On 2024-02-07 the FDA classified a Class II recall of ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Stapler, Endoscopic Linear Cutter Reload (+Gripping… by Ethicon Endo Surgery, citing there is the potential for incomplete staple line formation during the firing sequence, without most or all staples, which may lead to insufficient tissue apposition that could re….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0834-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-12-11 |
| Published | 2024-02-07 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ethicon Endo Surgery |
| Distribution | US |
Product
ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Stapler, Endoscopic Linear Cutter Reload (+Gripping Surface technology), 45MM WHITE VASCULAR/THIN, Product No. GST45W
Reason
There is the potential for incomplete staple line formation during the firing sequence, without most or all staples, which may lead to insufficient tissue apposition that could require surgical intervention. This may result in bleeding, prolonged surgery, or surgical delay.
Identifiers
| code_info | UDI-DI 10705036014928 Lots 442C02 and 442C03 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0834-2024%22
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