Z-0715-06

Rubicor EnCapsule Breast Biopsy Device, Part Number 31358, Product is manufactured and distributed by Rubicor...

Name: Z-0715-06 Rubicor EnCapsule Breast Biopsy Device, Part Number 31358, Product is manufactured and distributed by Rubicor...
Creator: Rubicor Medical
Published: 2006-02-17
License: https://open.fda.gov/license/

Rubicor Medical, Inc. / initiated 2006-02-17 / Terminated / root cause: sterility

FDA source

Rubicor Medical began a recall of Rubicor EnCapsule Breast Biopsy Device, Part Number 31358, Product is manufactured and distributed by Rubicor Medical, Inc., 600 Chesapeake Dr., Redwood City... on 2006-02-17. The reason FDA records is "Devices' sterility may be compromised due to lack of adequate sterilization". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0715-06
Status: Terminated
Initiated: 2006-02-17
Posted: 2006-04-11
Terminated: 2006-05-11
Recalling firm: Rubicor Medical, Inc.
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
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Devices' sterility may be compromised due to lack of adequate sterilization.
Root cause tag: sterility
FDA 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 in commerce: 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.
Product codes and lots: Lot number: 06011817

Product code GEI

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)