FDA Medical Device Recalls (openFDA)
Angiodynamics, INC: Habib, 4x Kit, Bipolar Resection Device RITA (Radiofrequency Ablation Devices). AngioDynamics, Inc., One Horizon Way, Manchester, GA 30816. Intended to be used to assist in coagulation of tissue during intraoperative surgical procedures.
- Recall number
- Z-3073-2011
- Recalling firm
- Angiodynamics, INC
- Product
- Habib, 4x Kit, Bipolar Resection Device RITA (Radiofrequency Ablation Devices). AngioDynamics, Inc., One Horizon Way, Manchester, GA 30816. Intended to be used to assist in coagulation of tissue during intraoperative surgical procedures.
- Status
- Terminated
- Initiated
- 2010-08-30
- Posted
- 2011-08-24
- Terminated
- 2012-03-12
- Reason
- The labeling contains errors which result in the products being misbranded
- Root cause
- Labeling False and Misleading
- Action
- AngioDynamics, Inc. sent out a "Medical Device Recall" letter dated August 30, 2010 to all affected customers. The letter included; products affected, problem and asked them to return the product back to AngioDynamics. Customers were asked to fill out and return the included Recall Reply Form. For question on this recall contact AngioDynamics at (800) 772-6446.
- Quantity
- 527 units
- Distribution
- Worldwide Distribution: (USA) Nationwide distribution and the countries of Austria, China, Denmark, Egypt, France Germany, India, Italy, Latvia, Netherlands, Poland, Russian Federation, South Africa, Switzerland and the United Kingdom
- Lot, serial or model codes
- Catalog number: 4401, Batch number: 511828, 511831, 511833, 513066, 513788, 513999, 514624, 515274, and 516914.
- 510(k) numbers
- ["K051420"]
- 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