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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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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Ethicon ECHELON LINEAR Cutters Reload Recalled for Lack of Sterilization

Agency Publication Date: October 14, 2025
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Summary

Ethicon Endo-Surgery Inc. has recalled 3 units of ECHELON LINEAR Cutters Reload (80 mm Blue, Product Number GLC80) because the devices were shipped unsterilized. These devices are intended for surgical procedures such as the creation of anastomoses, transection, and resection. Using unsterilized equipment during surgery poses a significant health risk to patients, including potential infections.

Risk

The use of unsterilized surgical instruments can introduce pathogens into a patient's body during surgery, potentially leading to serious infections, sepsis, or other life-threatening complications. No injuries have been reported in the available recall data.

What You Should Do

  1. This recall affects ECHELON LINEAR Cutters Reload 80 mm Blue with Product Number GLC80, specifically Lot Number 904C12 and UDI-DI 10705036030881.
  2. Stop using the recalled device immediately to prevent patient exposure to non-sterile equipment.
  3. Contact Ethicon Endo-Surgery Inc. or your local distributor to arrange for the return, replacement, or correction of the affected units.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this recall.

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: ECHELON LINEAR Cutters Reload 80 mm Blue
Variants: 80 mm Blue
Model / REF:
GLC80
Lot Numbers:
904C12
UDI:
10705036030881

Intended for transection, resection, and/or creation of anastomoses.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97654
Status: Active
Manufacturer: Ethicon Endo-Surgery Inc
Sold By: Medical distributors in United Arab Emirates
Manufactured In: United States
Units Affected: 3 units

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.