FDA Medical Device Recalls (openFDA)
C.R. Bard, Inc., Urological Division: Bard UroForce Balloon Dilation Catheter with Glissando Coating * BARD * C.R. Bard, Inc. Covington, Georgia 30014 * 1-800-526-4455 * Sterile/EO
- Recall number
- Z-0268-06
- Recalling firm
- C.R. Bard, Inc., Urological Division
- Product
- Bard UroForce Balloon Dilation Catheter with Glissando Coating * BARD * C.R. Bard, Inc. Covington, Georgia 30014 * 1-800-526-4455 * Sterile/EO
- Status
- Terminated
- Initiated
- 2005-11-03
- Posted
- 2005-12-03
- Terminated
- 2006-01-24
- Reason
- There is a potential for the lumen to collapse and prevent passage over a guidewire.
- Root cause
- Other
- Action
- Consignees were notified via overnight courier on 11/7&8/2005
- Quantity
- 480 units
- Distribution
- Nationwide, Belgium, Canada
- Lot, serial or model codes
- Catalog #887504, Lot #GFPG2394; Catalog #887510, Lot #GFPG2399; Catalog #887604, GFPG2401, GFPG2402, GFPG2403, GFPG2404, GFPG2405, GFPG2424; Catalog #887610, Lot #GFPF3439, GFPG2406; Catalog #888404, Lot #GFPG2409, Catalog #888604, Lot #GFPG2411, GFPH1415; Catalog #888510, Lot #GFPG2415, GFPH2024; Catalog #888604, Lot #GFPG2417, GFPG2418; Catalog #888610, Lot #GFPF3451.
- 510(k) numbers
- ["K993840"]
- PMA numbers
- not on file
- Product code
- EZN
- Firm FEI
- 1018233
- Firm city
- Covington
- 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