Carbon Medical Technologies, Inc. Mammotome MammoStar Biopsy Site Identified, REF STAR1401 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Mammotome MammoStar Biopsy Site Identified, REF STAR1401
Brand
Carbon Medical Technologies, Inc.
Lot Codes / Batch Numbers
UDI/DI 00858015005431, Lot Number 2201011A
Products Sold
UDI/DI 00858015005431, Lot Number 2201011A
Carbon Medical Technologies, Inc. is recalling Mammotome MammoStar Biopsy Site Identified, REF STAR1401 due to The label incorrectly identifies the product as STAR1401, a 1x3mm Barbell shaped marker pre-loaded in a 14 gauge needle, while the packaging contains . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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."
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