FDA Medical Device Recalls (openFDA)
Carbon Medical Technologies, Inc.: Mammotome MammoStar Biopsy Site Identified, REF STAR1401
- Recall number
- Z-1041-2023
- Recalling firm
- Carbon Medical Technologies, Inc.
- Product
- Mammotome MammoStar Biopsy Site Identified, REF STAR1401
- Status
- Terminated
- Initiated
- 2022-12-16
- Posted
- 2023-01-30
- Terminated
- 2023-08-09
- Reason
- The label incorrectly identifies the product as STAR1401, a 1x3mm Barbell shaped marker pre-loaded in a 14 gauge needle, while the packaging contains STAR1402, a 1x5mm Tribell shaped marker pre-loaded in a 14 gauge needle.
- Root cause
- Under Investigation by firm
- Action
- Carbon Medical Technologies sent an IMPORTANT: MEDICAL DEVICE RECALL notice by email to its sole consignee on 12/16/2022. The notice explained the issue and requested that the consignee perform the following actions: "Immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify you customers and notify them at once of this product recall." "Affected product should be returned to: Regulatory Affairs, Carbon Medical Technologies, Inc., 1290 Hammond Road, St. Paul, MN 55110-5959" "If you have any question, comments, or concerns please contact Customer Support at +1 888-207-2062. You may also email info@carbonmed.com."
- Quantity
- 550 devices
- Distribution
- US Nationwide distribution in the state of OHIO.
- Lot, serial or model codes
- UDI/DI 00858015005431, Lot Number 2201011A
- 510(k) numbers
- ["K100994"]
- PMA numbers
- not on file
- Product code
- NEU
- Firm FEI
- 3002619738
- Firm city
- Saint Paul
- Firm state
- MN
- 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