XLie with Tubing, 12 cm, Electrosurgical Device-RITA *… recallZ-0888-06 · Rita Medical Systems, Inc. · initiated May 2, 2006
Terminated All recalls posted in May 2006
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Rita Medical Systems, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Misbranding; Product may have the wrong device handle which incorrectly identifies the product and also has incorrect deployment depth marker
FDA root cause category: Other
What the company is doing
Consignees were first notified by telephone on 05/02/2006. A follow up letter was sent on 05/03/2006. The European Medical Device Agency, the Italian Competent Authority and British Standards Institution were notified by email on 05/03/2006.
Recall details
- Recall number
- Z-0888-06
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- May 2, 2006
- Posted by the FDA
- May 31, 2006
- Recalling firm
- Rita Medical Systems, Inc.
- Quantity
- 19 units
- Product code
- GEI
- FDA submissions
- K010060
- Distribution
- AL, AR, FL, LA, MA, NJ, NY, PA, TN, TX, UT and Italy
Product description
XLie with Tubing, 12 cm, Electrosurgical Device-RITA * Medical Systems, Inc. * StarBurst Xli enhanced with tubing set * * REF/Catalog: 700-103027 * 4-7 cm Diameter * 12cm Length * Sterile/R * RITA * Manufactured by: Rita Medical Systems, Inc., One Horizon Way, Manchester, Georgia 31816, USA
Code information (models, lots, serial numbers)
Catalog number: 700-103027, Lot number 25952
Other devices under the same FDA submission
3 devices cleared under K010060 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- StarBurst Talon 700-102847Navilyst Medical, Inc. · ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES11 reports
- StarBurst Talon 700-102845Navilyst Medical, Inc. · ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES10 reports
- StarBurst Talon 700-102846Navilyst Medical, Inc. · ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 35342).
- Z-0887-06 · TerminatedTalon Straight, 25 cm--Electrosurgical Device--RITA * Medical Systems, Inc. * StarBurst Talon * * REF: 700-102846 * 4 cm Diameter * 25 cm Length * Sterile/R * Catalog # 700-102846-…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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