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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices/Surgical Equipment

Ethicon Echelon Vascular White Reload Recalled for Instrument Lockout Risk

Agency Publication Date: May 20, 2025
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Summary

Ethicon Endo-Surgery Inc. has recalled 678,526 units of the Endopath Echelon Vascular White Reload for Advanced Placement Tip (model VASECR35). The recall was initiated due to an increase in reports that the device may lock out during surgery, meaning it activates momentarily but fails to cut or staple tissue. Two adverse events have been reported in connection with this issue, including one patient death.

Risk

If the device locks while attached to tissue, surgeons may have difficulty removing it, leading to surgical delays, severe bleeding, or life-threatening hemorrhagic shock. In some cases, the patient may require more invasive 'open' surgery to resolve the complication.

What You Should Do

  1. This recall affects the Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row) with product code VASECR35 and UDI-DI GTIN 10705036014591.
  2. Check your medical facility inventory for packaging batches including 917C65, 895C93, 918C15, 938C92, 936C69, and others. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device immediately. Contact Ethicon Endo-Surgery Inc. or your distributor to arrange for the return, replacement, or correction of the affected units.
  4. Call the FDA Consumer Complaint hotline at 1-888-463-6332 or visit the FDA website at www.fda.gov/medical-devices/medical-device-recalls for additional information.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row)
Model / REF:
VASECR35
Lot Numbers (57):
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
UDI:
10705036014591
GTIN:
10705036014591

Recall #: Z-1746-2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96750
Status: Active
Manufacturer: Ethicon Endo-Surgery Inc
Sold By: Ethicon Endo-Surgery Inc
Manufactured In: United States
Units Affected: 678,526
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.