Ethicon Endo-Surgery Inc recalls ECHELON LINEAR Cutters Reload 80 mm Blue
Reason for recall
The devices were shipped unsterilized.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC80
Lot / code information
- UDI
- 10705036030881
- Lot #
- 904C12
What the firm is doing
An IMPORTANT CUSTOMER NOTIFICATION was sent to customers beginning 9/11/25. Actions Required Complete the Business Reply Form (BRF) (Attachment 1) confirming receipt and your understanding of this notification.
DistributionShow detailsHide
International distribution to the countries of United Arab Emirates.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-0147-2026
- FDA 510(k) clearance · K223760The device's official FDA premarket clearance record
- FDA device classification · GDWOfficial FDA classification for this device type
- CFR regulation · 21 CFR 878.4750The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Ethicon Endo-Surgery IncSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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