Starion Instruments Starion Instruments Real Hand ThermaSeal Thermal Ligating Shears, electrosurgical cutting and coagulation device and accessories, manufactured by Starion Instruments, Sunnyvale, CA Intended use: Medical Device used for cutting and cauterization of soft tissue during surgery, and of natural or synthetic, non-metallic sutures during surgery. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Starion Instruments Real Hand ThermaSeal Thermal Ligating Shears, electrosurgical cutting and coagulation device and accessories, manufactured by Starion Instruments, Sunnyvale, CA Intended use: Medical Device used for cutting and cauterization of soft tissue during surgery, and of natural or synthetic, non-metallic sutures during surgery.
Brand
Starion Instruments
Lot Codes / Batch Numbers
Model Number N-10700, lot numbers 80419, 806009, 804037, 804035, 804036, 804019A.
Products Sold
Model Number N-10700, lot numbers 80419, 806009, 804037, 804035, 804036, 804019A.
Starion Instruments is recalling Starion Instruments Real Hand ThermaSeal Thermal Ligating Shears, electrosurgical cutting and coagul due to Due to an improper fixture revision, device may be missing a screw at the jaw assembly, resulting in jaw components falling off during use.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to an improper fixture revision, device may be missing a screw at the jaw assembly, resulting in jaw components falling off during use.
Recommended Action
Per FDA guidance
The firm submitted an MDR but determined that there was no risk to health. E-mails were sent on June 26, 2008, to consignees, describing the product, the problem, and action to be taken by consignees. The consignees were ask to provide a list of all unused ThermaSeal devices and their locations, to return the products to Starion from the lots noted and to provide a copy of the attached letter to their sales force and customers if they choose. If you have any questions, please call (408) 522-5200 ext. 326 or (408) 350-9934.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026