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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Ethicon Endo-Surgery
- Product type
- Endoscopic Linear Cutter
- Model numbers
- GLC80, UDI-DI: 10705036030881, Lot Number: 904C12
- Colors
- Blue
- Sizes
- 80 mm
- Sold at
- Unknown
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 11, 2025
Reported by FDA DEVICE
October 22, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
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
About This Product
The ECHELON Linear Cutter Reload is used in surgical procedures to transect, resect, and create anastomoses during minimally invasive surgery.
Why This Is Dangerous
Unsterilized devices pose a potential infection or contamination risk to patients during procedures.
Industry Context
This recall is not indicated as part of a broader industry pattern.
Real-World Impact
Affecting 3 units distributed internationally to UAE. No injuries reported yet. Potential risk during surgical procedures if unsterilized devices are used.
Practical Guidance
How to identify if yours is affected
- Verify device matches ECHELON Linear Cutter Reload 80 mm Blue (GLC80)
- Check UDI-DI 10705036030881 on packaging/label
- Check Lot Number 904C12
- Refer to FDA recall page Z-0147-2026 for instructions
Where to find product info
Serials, UDI, and lot numbers are on device packaging and labeling. FDA recall page linked in the notice.
What timeline to expect
Remedy and replacement timelines typically 4-8 weeks for processing.
If the manufacturer is unresponsive
- Escalate to hospital compliance or regulatory affairs
- File a report with FDA if there is a delay in remediation
- Keep records of all communications
How to prevent similar issues
- Always verify sterility and packaging integrity before use
- Rely on manufacturer-issued recalls for device sterilization status
- Confirm device model and lot numbers match recall notice
Documentation advice
Keep copies of recall letters, packaging, and correspondence; photograph packaging and labeling for records.
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Product Details
ECHELON LINEAR Cutters Reload 80 mm Blue, Product Number GLC80. Manufacturer: Ethicon Endo-Surgery. Recall date: 2025-09-11. Distribution: International, UAE. Quantity: 3 units. UDI-DI: 10705036030881. Lot Number: 904C12.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Product Number GLC80
- Lot Number 904C12
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Safety Guide
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