FDA Medical Device Recalls (openFDA)
Starion Instruments: The Starion Instruments Thermal Ligating Shears 35C Model 102-138D and 23C Model numbers 102-137D allow the surgeon to position the distal jaws of the instrument around the region of tissue to be cut/cauterized. The surgeon squeezes the handle and depresses the switch, heating elements activates in the jaws. The heat is conducted to the tissue between the jaws to provide cutting/cauterization. For the simultaneous cutting and cauterization of soft tissue during surgery. Cutting of natural or synthetic, non-metallic, sutures during surgery.
- Recall number
- Z-2239-2010
- Recalling firm
- Starion Instruments
- Product
- The Starion Instruments Thermal Ligating Shears 35C Model 102-138D and 23C Model numbers 102-137D allow the surgeon to position the distal jaws of the instrument around the region of tissue to be cut/cauterized. The surgeon squeezes the handle and depresses the switch, heating elements activates in the jaws. The heat is conducted to the tissue between the jaws to provide cutting/cauterization. For the simultaneous cutting and cauterization of soft tissue during surgery. Cutting of natural or synthetic, non-metallic, sutures during surgery.
- Status
- Terminated
- Initiated
- 2010-03-09
- Posted
- 2010-08-19
- Terminated
- 2010-11-27
- Reason
- The Starion Instruments Thermal Ligating Shears (STLS) 35C and the Starion Thermal Ligating Shears (STLS) 23C may turn on and remain on without the finger button being depressed. The devices may also work intermittently, incorrectly indicating the device is 'on".
- Root cause
- Device Design
- Action
- Starion distributed a "STLS Device Recall - Important Medical Device Information" letter dated March 9, 2010 to consignees. The letter identified the affected model and lot numbers. Consignees were asked to complete a inventory status form and fax to Starion. the letter included a shipping labe with a pre-assigned return authorization number. Starion will ship replacement after receipt of the inventory status form and returned product..
- Quantity
- 228 units
- Distribution
- Worldwide Distribution: USA states of CA, OH, MI, KS and MO and countries of Italy, China, Kuwait, and Germany.
- Lot, serial or model codes
- STLS 23C: Model numbers 102-137D, Lot Numbers: 905029, 907007, 910016, 908022 STLS 35C: Model 102-138D, Lot Numbers: 907004 and 907008
- 510(k) numbers
- ["K062257"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 1000137656
- Firm city
- Sunnyvale
- Firm state
- CA
- 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