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Rubicor Medical, Inc.

United StatesFDA applicant, unverified

Devices
8
FDA recalls
1

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

Catalogue8

Newest first, rows 1-8 of 8

FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

  • 2006

    • 17 Feb 2006 Z-0715-06 Unclassified (pre-2012) Terminated Devices' sterility may be compromised due to lack of adequate sterilization. Distribution: Nationwide. The product was released for distribution to 19 consignees in US. The firm''s sales force were able to…
      Full distribution text 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.
      Submission numbers: K020047, K023601, K030049, K032584, K052506

Frequently asked questions

How many devices does Rubicor Medical, Inc. have in the registry?

The registry currently lists 8 devices for Rubicor Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Rubicor Medical, Inc.'s devices?

Among its 8 most recently registered devices, Rubicor Medical, Inc. has devices listed in FDA 510(k) (8 devices).

What risk classes do Rubicor Medical, Inc.'s devices fall under?

Among its 8 most recently registered devices, the classes recorded for Rubicor Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Rubicor Medical, Inc.?

FDA recall records list 1 recall initiated by Rubicor Medical, Inc., the most recent initiated on 17 Feb 2006. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Rubicor Medical, Inc. in the registry?

The most recently registered devices listed for Rubicor Medical, Inc. include RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30629, RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30086, RUBICOR MAGIC BREAST BIOPSY DEVICE, MODEL 31537 and RUBICOR BREAST BIOPSY DEVICE.

Generated automatically from registry data and not verified by a human reviewer.