Carbon Medical recalls Mammotome MammoStar Biopsy Site Identified (REF STAR1401) due to incorrect labeling between product models. Affected units have a specific UDI/DI and lot number.
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.
Carbon Medical is recalling a specific Mammotome biopsy device because its label incorrectly identifies it as a different model. This could lead to confusion with a similar but distinct product, potentially causing incorrect use.
The device label incorrectly states it is STAR1401 (a 1x3mm Barbell marker), but the packaging shows it is STAR1402 (a 1x5mm Tribell marker). This labeling error could cause confusion between two similar but distinct products, potentially leading to incorrect use.
Medical professionals using the Mammotome MammoStar Biopsy Site Identified device are likely affected. Those who purchased the product with the specific UDI/DI 0085801:15005431 and lot number 2201011A are most at risk.
Check the label on the device for the model number. Affected units have a UDI/DI of 00858015005431 and lot number 2201011A.
Look for the model number on the device label to confirm it matches STAR1401.
The label incorrectly identifies the product as STAR1401, while the packaging shows it is STAR1402. This labeling error could cause confusion with a similar but distinct product.
Check the device label for the model number. If it matches STAR1401 with UDI/DI 00858015005431 and lot number 2201011A, it is affected.
The recall record does not mention a remedy or fix for this labeling error.
We’ve drafted a message you can send Carbon Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1041-2023 — Carbon Medical Carbon Medical Hello, I own a Carbon Medical that is covered by recall Z-1041-2023 from Carbon Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
