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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Rubicor Medical
Lot Codes / Batch Numbers
Lot number: 06011817
Products Sold
Lot number: 06011817
Rubicor Medical is recalling Rubicor EnCapsule Breast Biopsy Device, Part Number 31358, Product is manufactured and distributed due to Devices' sterility may be compromised due to lack of adequate sterilization.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Devices' sterility may be compromised due to lack of adequate sterilization.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026