Z-1969-2010

Starion Instruments TLS3 35C Thermal Ligating Shears, Electrosurgical cutting and coagulation device and...

Name: Z-1969-2010 Starion Instruments TLS3 35C Thermal Ligating Shears, Electrosurgical cutting and coagulation device and...
Creator: Starion Instruments
Published: 2008-02-06
License: https://open.fda.gov/license/

Microline Surgical, Inc / initiated 2008-02-06 / Terminated / root cause: manufacturing process

FDA source

Starion Instruments began a recall of Starion Instruments TLS3 35C Thermal Ligating Shears, Electrosurgical cutting and coagulation device and accessories, manufactured by Starion Instruments Corp... on 2008-02-06. The reason FDA records is "Some jaws exhibited lack of ductility and could break if overloaded or used improperly by placing too much tissue in the bottom of the "v" of the jaw". 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-1969-2010
Status: Terminated
Initiated: 2008-02-06
Posted: 2010-07-08
Terminated: 2010-11-27
Recalling firm: Microline Surgical, Inc
Product: Starion Instruments TLS3 35C Thermal Ligating Shears, Electrosurgical cutting and coagulation device and accessories, manufactured by Starion Instruments Corp, Sunnyvale, CA. Intended use: medical device for use in cutting and cauterization of soft tissue during surgery, as well as cutting of natural or synthetic, non-metallic sutures during surgery.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Some jaws exhibited lack of ductility and could break if overloaded or used improperly by placing too much tissue in the bottom of the "v" of the jaw.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm called domestic consignees but no letter was sent to domestic cosignees and a notification letter was sent to international consignees. The firm called domestic consignees and sent a notification letter to international consignees. No records were kept of phone calls and a copy of the letter sent to international consignees was not obtained
Distribution: Worldwide distribution
Product codes and lots: Model number 132-136D, lot numbers 708027 and 710008, expiration dates 09/21/12 and 10/19/12

Product code GEI

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)