FDA Medical devices recall ·
ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection… recall
- Recall number
- Z-0147-2026
- Date
- (initiated September 11, 2025)
- Company / brand
- Ethicon Endo Surgery, LLC
4545 Creek Rd, Blue Ash, OH, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 3 units
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC80
Why was it recalled?
The devices were shipped unsterilized.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 10705036030881; Lot Number: 904C12
Distribution
International distribution to the countries of United Arab Emirates.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0147-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.