Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VAS...
FDA Device Recall #Z-1746-2025 — Class I — April 22, 2025
Recall Summary
| Recall Number | Z-1746-2025 |
| Classification | Class I — Serious risk |
| Date Initiated | April 22, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Ethicon Endo-Surgery Inc |
| Location | Blue Ash, OH |
| Product Type | Devices |
| Quantity | 678,526 |
Product Description
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.
Distribution Pattern
US distribution nationwide. OUS distribution to EMEA, LATAM, APAC, and Canada.
Lot / Code Information
UDI-DI GTIN 10705036014591 Packaging Batches: 917C65 895C93 918C15 938C92 936C69 929C38 948C78 990C81 979C81 400D82 962C74 506D29 379D80 413D56 418D41 419D47 415D43 427D07 434D35 442D78 442D83 444D96 456D87 455D03 493D27 468D88 482D30 502D90 489D62 134D80 112D03 155D33 159D49 181D11 194D77 125D04 167D13 223D59 175D72 234D11 238D70 261D10 270D69 317D74 194D76 349D54 347D73 317D73 356D54 326D66 319D76 338D99 336D39 356D53 367D26 378D04 214D17
Other Recalls from Ethicon Endo-Surgery Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0147-2026 | Class II | ECHELON LINEAR Cutters Reload 80 mm Blue, inten... | Sep 11, 2025 |
| Z-0834-2024 | Class II | ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SUR... | Dec 11, 2023 |
| Z-2355-2021 | Class II | HARMONIC HD 1000i Shears (20cm Shaft Length)-in... | Jul 20, 2021 |
| Z-2356-2021 | Class II | HARMONICHD 1000i Shears (36cm Shaft Length)-ind... | Jul 20, 2021 |
| Z-2326-2021 | Class II | ECHELON FLEX Powered Plus Stapler-intended for ... | Jun 3, 2021 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.