MammoStar recallZ-1041-2023 · Carbon Medical Technologies, Inc. · initiated Dec 16, 2022
Class II Terminated All recalls posted in January 2023
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Carbon Medical Technologies, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
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]."
Recall details
- Recall number
- Z-1041-2023
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Dec 16, 2022
- Posted by the FDA
- Jan 30, 2023
- Recalling firm
- Carbon Medical Technologies, Inc.
- Quantity
- 550 devices
- Product code
- NEU
- FDA submissions
- K100994
- Distribution
- US Nationwide distribution in the state of OHIO.
Product description
Mammotome MammoStar Biopsy Site Identified, REF STAR1401
Code information (models, lots, serial numbers)
UDI/DI 00858015005431, Lot Number 2201011A
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- MammoStar™ STAR1402Carbon Medical Technologies, Inc. · Marker, Radiographic, Implantable1 recall1 report
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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