Z-1041-2023Class II

Mammotome MammoStar Biopsy Site Identified, REF STAR1401

Name: Z-1041-2023 Mammotome MammoStar Biopsy Site Identified, REF STAR1401
Creator: Carbon Medical Technologies, Inc.
Published: 2022-12-16
License: https://open.fda.gov/license/

Carbon Medical Technologies, Inc. / initiated 2022-12-16 / Terminated / root cause: labeling and UDI

FDA source

Carbon Medical Technologies, Inc. began a recall of Mammotome MammoStar Biopsy Site Identified, REF STAR1401 on 2022-12-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1041-2023
Classification: Class II
Status: Terminated
Initiated: 2022-12-16
Posted: 2023-01-30
Terminated: 2023-08-09
Recalling firm: Carbon Medical Technologies, Inc.
Product: Mammotome MammoStar Biopsy Site Identified, REF STAR1401
Product code: NEU Marker, Radiographic, Implantable
Reason for recall: 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 tag: labeling and UDI
FDA 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 [email protected]."
Quantity in commerce: 550 devices
Distribution: US Nationwide distribution in the state of OHIO.
Product codes and lots: UDI/DI 00858015005431, Lot Number 2201011A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1041-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1041-2023	Class II	Terminated	Voluntary: Firm initiated	2023-02-08	2023-01-30

Product code NEU

K100994Class IIPreloaded Tissue Marker DeviceCarbon Medical Technologies, Inc. / cleared 2010-04-30

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)