FDA Medical Device Recalls (openFDA)
Ethicon Endo-Surgery Inc: Enseal TRIO Product Code ETRIO335H, Lot Code: G4TC14, Exp. Date 2012/05
- Recall number
- Z-2635-2010
- Recalling firm
- Ethicon Endo-Surgery Inc
- Product
- Enseal TRIO Product Code ETRIO335H, Lot Code: G4TC14, Exp. Date 2012/05
- Status
- Terminated
- Initiated
- 2010-07-09
- Posted
- 2010-09-30
- Terminated
- 2011-02-14
- Reason
- The weld that connects the electrode to the active rod was separated. This connection is critical to the proper function of these devices. If the weld is separated, the product will not deliver energy to the jaws, resulting in the potential for a cut/transection without a seal. Ethicon Endo-Surgery identified this issue during a routine finished goods quality inspection.
- Root cause
- Other
- Action
- Ethicon Endo-Surgery issued an Urgent: Device Recall, Event 2193 letter dated July 19, 2010 identifying the affected device, the issue prompting the recall, and actions to be taken by consignees. Consignees were instructed: Do not use the affected product. Identify and quarantine affected product from inventory. Complete the Business Reply form and fax to Stericycle at 877-597-9580 within three days To return product, place it in a box with a copy of the Business Reply form and mail to Stericycle using the pre-printed UPS shipping label. Replacement product should be received by the customer within 60 days of return of affected product. Customers can contact Stericycle about this recall at 877-243-7314 and referencing Event 2193.
- Quantity
- 396 instruments
- Distribution
- Nationwide Distribution to the following states: AZ, AL, AZ, CA, CO, CT, FL, GA, IN, KY, MA, MD, MI, MO, MS, NC, NV, NY, OH, PA, TN, TX, WA, and WV.
- Lot, serial or model codes
- Product Code ETRIO335H, Lot Code: G4TC14, Exp. Date 2012/05
- 510(k) numbers
- ["K070165","K070896","K072177"]
- PMA numbers
- not on file
- Product code
- NLM
- Firm FEI
- 1527736
- Firm city
- Cincinnati
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28