Z-2635-2010

Enseal TRIO Product Code ETRIO335H, Lot Code: G4TC14, Exp. Date 2012/05

Name: Z-2635-2010 Enseal TRIO Product Code ETRIO335H, Lot Code: G4TC14, Exp. Date 2012/05
Creator: Ethicon Endo-Surgery Inc
Published: 2010-07-09
License: https://open.fda.gov/license/

Ethicon Endo-Surgery Inc / initiated 2010-07-09 / Terminated / root cause: manufacturing process

FDA source

Ethicon Endo-Surgery Inc began a recall of Enseal TRIO Product Code ETRIO335H, Lot Code: G4TC14, Exp. Date 2012/05 on 2010-07-09. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2635-2010
Status: Terminated
Initiated: 2010-07-09
Posted: 2010-09-30
Terminated: 2011-02-14
Recalling firm: Ethicon Endo-Surgery Inc
Product: Enseal TRIO Product Code ETRIO335H, Lot Code: G4TC14, Exp. Date 2012/05
Product code: NLM Laparoscope, General & Plastic Surgery, Reprocessed
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: Product Code ETRIO335H, Lot Code: G4TC14, Exp. Date 2012/05

Product code NLM

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)