ENDOPATH ECHELON" Vascular White Reload for Advanced Placement Tip, Product Usage: The instr...

FDA Device Recall #Z-1641-2015 — Class II — February 26, 2015

Recall Summary

Recall Number Z-1641-2015
Classification Class II — Moderate risk
Date Initiated February 26, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Ethicon Endo-Surgery Inc
Location Blue Ash, OH
Product Type Devices
Quantity 6,744 devices

Product Description

ENDOPATH ECHELON" Vascular White Reload for Advanced Placement Tip, Product Usage: The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic and pediatric surgical procedures.

Reason for Recall

During an internal inspection of the production process the firm discovered an issue which may cause the cartridge to deploy an incomplete staple line.

Distribution Pattern

Worldwide Distribution - US Nationwide in the states of: AR, AZ, CA, CO, DE, FL, GA, IA, IL, KS, KY, LA, MA, ME, MI, MN, MO, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA & WI and the country of Hong Kong.

Lot / Code Information

M/N: VASECR35; Product Lot L4FF3W, Expiry Date 2017-11; Product Lot L4FF3X, Expiry Date 2017-11; Product Lot L4FF3Y, Expiry Date 2017-11; Product Lot M4H046, Expiry Date 2017-12; Product Lot M4H105, Expiry Date 2017-12; Product Lot M4H27D, Expiry Date 2017-12; Product Lot M4H30H, Expiry Date 2017-12; Product Lot M4H37J, Expiry Date 2017-12; Product Lot M4H399, Expiry Date 2017-12; Product Lot M4H589, Expiry Date 2018-01; Product Lot M4H54M, Expiry Date 2018-01; Product Lot M4H643, Expiry Date 2018-01 & Product Lot M4H691, Expiry Date 2018-01..

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-1746-2025 Class I Endopath Echelon Vascular White Reload for Adva... Apr 22, 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

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.