FDA Medical Device Recalls (openFDA)
Rita Medical Systems, Inc.: RITA StarBurst (2-3cm Diameter/25cm Length), Electro-surgical Device, Manufactured by: RITA Medical Systems, Inc., One Horizon Way, Manchester, GA 31816
- Recall number
- Z-0753-2007
- Recalling firm
- Rita Medical Systems, Inc.
- Product
- RITA StarBurst (2-3cm Diameter/25cm Length), Electro-surgical Device, Manufactured by: RITA Medical Systems, Inc., One Horizon Way, Manchester, GA 31816
- Status
- Terminated
- Initiated
- 2007-04-03
- Posted
- 2007-04-19
- Terminated
- 2010-01-20
- Reason
- The product may have a cracked tray which can compromise the sterility of the product.
- Root cause
- Other
- Action
- Notification by letter of the AngioDynamics, Inc. sales force and the domestic and international distributors began on April 2, 2007. They were asked to return all affected devices to the Manchester, GA division of AngioDynamics, Inc. A reply form was attached to be completed and returned via fax to AngioDynamics.
- Quantity
- 751 devices
- Distribution
- Worldwide, including USA, Austria, Canada, Croatia, Denmark, Egypt, Estonia, France, Finland, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Latvia, Netherlands, Norway, Poland, Republic of Ireland, Romania, Russia, Saudi Arabia, Singapore, Solomon Islands, South Africa, Spain, Switzerland, UK, and United Arab Emirates.
- Lot, serial or model codes
- Product number: 700-101493, Lot number: 22442, 25551, 26583, 26937, 27439, 27807 & 29778 and Product number: 700-101493J (Japanese distribution), Lot number: 25599, 25640, 25641, 25642, 25982, 26718, 26719, 26805, 26806, 27045, 27177, 27716, 27717, 27808, 27809, 27941, 27959, 27960, 27975, 27976, 27977, 28436, 28437, 28438, 28518, 28519, 28520, 28521, 28522, 28523, 28524, 28558, 28582, 28583 & 28584
- 510(k) numbers
- ["K983871"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 3017892510
- Firm city
- Manchester
- Firm state
- GA
- 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