HIGH

Ethicon Endo-Surgery Recalls Sterilization Defective Surgical Devices

Ethicon Endo-Surgery recalled three units of the ECHELON LINEAR Cutters Reload 80 mm Blue on September 11, 2025. The devices were shipped unsterilized, posing a high health risk. The recall affects surgical devices in the United Arab Emirates.

Quick Facts at a Glance

Recall Date
September 11, 2025
Hazard Level
HIGH
Brand
Ethicon Endo-Surgery
Category
Health & Personal Care
Sold At
Unknown
At-Risk Groups
GENERAL

Hazard Information

The devices were shipped unsterilized.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Ethicon Endo-Surgery Inc or your healthcare provider for instructions. Notification method: Letter

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Product Details

The recalled product is the ECHELON LINEAR Cutters Reload 80 mm Blue, Product Number GLC80. The specific model numbers include UDI-DI: 10705036030881 and Lot Number: 904C12. The devices were distributed internationally, specifically to the United Arab Emirates.

The Hazard

The devices were shipped unsterilized, which presents a significant risk of infection during surgical procedures. Unsterilized medical devices can lead to severe complications and healthcare-associated infections.

Reported Incidents

No specific incidents or injuries have been reported related to this recall. However, the lack of sterilization raises serious concerns regarding potential infections.

What to Do

Stop using the device immediately. Follow the recall instructions provided by the manufacturer. For further guidance, contact Ethicon Endo-Surgery Inc or consult your healthcare provider.

Contact Information

For more information, reach Ethicon Endo-Surgery Inc at their official website. You can also visit the FDA recall report at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0147-2026.

Key Facts

  • Recall date: September 11, 2025
  • Report date: October 22, 2025
  • Quantity recalled: 3 units
  • Distribution: United Arab Emirates

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
UDI-DI: 10705036030881
Lot Number: 904C12
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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