FDA Medical Device Recalls (openFDA)
Rubicor Medical: Rubicor EnCapsule Breast Biopsy Device, Part Number 31358, Product is manufactured and distributed by Rubicor Medical, Inc., 600 Chesapeake Dr., Redwood City, CA 94063
- Recall number
- Z-0715-06
- Recalling firm
- Rubicor Medical
- Product
- Rubicor EnCapsule Breast Biopsy Device, Part Number 31358, Product is manufactured and distributed by Rubicor Medical, Inc., 600 Chesapeake Dr., Redwood City, CA 94063
- Status
- Terminated
- Initiated
- 2006-02-17
- Posted
- 2006-04-11
- Terminated
- 2006-05-11
- Reason
- Devices' sterility may be compromised due to lack of adequate sterilization.
- Root cause
- Other
- Action
- On 2/17/06, the firm initiated the recall and its notification was via sales rep retrieval and follow-up letter dated 3/13/06 explaining the reason for the recall and requesting the product be returned.
- Quantity
- 19 units
- Distribution
- Nationwide. The product was released for distribution to 19 consignees in US. The firm''s sales force were able to retrieve 18 units, only one (1) was used by a consignee. The recall was appropriately extended to the consumer/user level; i.e., the wholesalers/distributors, pharmacists, physicians who received the recalled product. There were no shipments to U.S. Government facilities or foreign or Canadian distribution.
- Lot, serial or model codes
- Lot number: 06011817
- 510(k) numbers
- ["K020047","K023601","K030049","K032584","K052506"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 3004014191
- Firm city
- Redwood City
- Firm state
- CA
- 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