FDA Medical Device Recalls (openFDA)
TissueLink Medical, Inc.: Tissuelink Dissecting Sealer DS3.5-C, Sterile Ref 13-121-1
- Recall number
- Z-0563-05
- Recalling firm
- TissueLink Medical, Inc.
- Product
- Tissuelink Dissecting Sealer DS3.5-C, Sterile Ref 13-121-1
- Status
- Terminated
- Initiated
- 2005-02-07
- Posted
- 2005-02-25
- Terminated
- 2005-04-20
- Reason
- The tip may separate from the device and render it unusable
- Root cause
- Other
- Action
- TissueLink notified consignees by Federal Express Letter from 2/7/05 to 2/8/05. Users are requested to return devices in inventory.
- Quantity
- 588 units
- Distribution
- AZ, CA, CO, CT, DE, IL, FL, KS, KY, OH, MA, MD MO,NC, NY, PA, RI, SC, TN,TX, VA Foreign: Italy, Turkey, Egypt, Spain, Peru, Portugal, Australia, Netherlands Government: VA Medical Center 508 Fulton Street Durham, NC 27005 VA Medical Center- 7400 Merton Minter Blvd San Antonio, TX 78229 VA Medical Center- Pittsburgh University C Pittsburgh, PA 15240
- Lot, serial or model codes
- Lot Number: TL033300
- 510(k) numbers
- ["K014260"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 1000517638
- Firm city
- Dover
- Firm state
- NH
- 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