FDA Medical Device Recalls (openFDA)
C.R. Bard, Inc.: Bard Dimension Stone Basket Product Usage: The Bard Dimension Stone basket is a teardrop-shaped basket with the ability to capture stones by, opening and closing the basket and articulating or moving the basket from side to side. The device consists of 3 main parts; handle, shaft and basket. It is intended to use in the endoscopic removal of renal and ureteral stones.
- Recall number
- Z-0163-2015
- Recalling firm
- C.R. Bard, Inc.
- Product
- Bard Dimension Stone Basket Product Usage: The Bard Dimension Stone basket is a teardrop-shaped basket with the ability to capture stones by, opening and closing the basket and articulating or moving the basket from side to side. The device consists of 3 main parts; handle, shaft and basket. It is intended to use in the endoscopic removal of renal and ureteral stones.
- Status
- Terminated
- Initiated
- 2014-10-07
- Posted
- 2014-10-31
- Terminated
- 2015-06-12
- Reason
- The product is non-sterile.
- Root cause
- Release of Material/Component prior to receiving test results
- Action
- Bard sent an Urgent: Medical Device Recall letter to each customer on 10/7/2014 with proof of delivery notice. Wholesalers were asked to conduct a sub-recall. Letter identify the affected product, problem and actions to be taken. Customers were instructed to examine their inventory and quarantine product subject to recall, do not use or further distribute any of the affected product, remove and return affected product to Bard Medical Division, and if the product have been further distributed identify your customers and notify them at once of the product recall. Customers were instructed to complete the enclosed Recall & Effectiveness Check Form and fax to 1-770-784-6469. For questions call 1-770-784-6471.
- Quantity
- 86 units
- Distribution
- Worldwide Distribution in the states of AL, FL, NJ, NY, NC, PA, SC, TX, WI, and countries of Germany, Italy, Kuwait, and Luxembourg.
- Lot, serial or model codes
- Product code: 042316, Lot number: BMXJM031
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FFL
- 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