Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Mammotome MammoStar Biopsy Site Identified Recalled by Carbon Medical Technologies, Inc. Due to The label incorrectly identifies the product as STAR1401,...

Date: December 16, 2022
Company: Carbon Medical Technologies, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Carbon Medical Technologies, Inc. directly.

Affected Products

Mammotome MammoStar Biopsy Site Identified, REF STAR1401

Quantity: 550 devices

Why Was This 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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Carbon Medical Technologies, Inc.

Carbon Medical Technologies, Inc. has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report