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Lower risk Medical device recall · FDA · Published September 11, 2025

Ethicon ECHELON LINEAR Cutters Reload 80mm Blue: Unsterilized Risk

Ethicon recalls ECHELON LINEAR Cutters Reload 80mm Blue devices shipped unsterilized. These surgical tools may cause infection if used without proper sterilization.

🇺🇸 FDA recall #Z-0147-2026Medical deviceEthicon ›
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Recalling firmEthicon Endo-Surgery Inc4545 Creek Rd · Blue Ash, OH 45242-2803
✎ GovInfoNow plain-language explainer

Ethicon is recalling ECHELON LINE: 80mm Blue surgical cutters that were shipped unsterilized. Using these devices without proper sterilization could lead to infections. Read more at govinfonow.com/recall/51332-ethicon-echelon-linear-cutters-reload-80mm-blue-unsterilized-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/51332-ethicon-echelon-linear-cutters-reload-80mm-blue-unsterilized-risk · Updated August 17, 2026 · FDA enforcement record: FDA #Z-0147-2026

Cite this page

“Ethicon ECHELON LINEAR Cutters Reload 80mm Blue: Unsterilized Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51332-ethicon-echelon-linear-cutters-reload-80mm-blue-unsterilized-risk. Based on FDA recall #Z-0147-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0147-2026%22&limit=1).

Ethicon Endo-Surgery Inc recalled ECHELON LINEAR Cutters Reload 80 mm Blue units distributed to the United Arab Emirates due to unsterilized devices, the FDA said on Sept. 11, 2025.

How to tell if you have it

  • Brand: Ethicon
  • Product: ECHELON LINEAR Cutters Reload 80 mm Blue
  • Product Number: GLC80
  • UDI-DI: 10705036030881
  • Lot Number: 904C12

The hazard

The devices were shipped unsterilized, according to the FDA.

Context

GovInfoNow's records show Ethicon Endo-Surgery Inc has 12 other recalls on record since Oct. 23, 2017. Other recent recalls of similar products include Covidien Dermalon 4-0 Blue 75cm Sutures Recall (June 24, 2026), Medline Convenience Kits: Risk of Contaminated Sterilized Products (Jan. 7, 2026), and Boston Scientific CRE Pro Wireguided 18-20mm 240cm (May 21, 2026).

How to tell if you have this one

Check for the product name 'ECHELON LINEAR Cutters Reload 80 mm Blue', product number GLC80, and lot number 904C12. These devices were sold by Ethicon Endo-Surgery Inc.

  • Brand
    Ethicon
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Device Details

    Identify the product name, product number GLC80, and lot number 904C12 to confirm if your device is recalled.

How this recall unfolded

Recall timeline

FDA published this recall 41 days after the firm started it.

1. Firm started the recall: Sep 11, 202512. FDA classified it Class II: Oct 14, 202523. Published in FDA’s Enforcement Report: Oct 22, 202532025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

Is there a risk of serious injury from this product?

The recall indicates a risk of infection from unsterilized devices, but no mention of serious injury or death.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0147-2026 (September 11, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0147-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA