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Artoura Breast Tissue Expanders
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MEDICAL DEVICE RECALLMODERATE

Artoura Breast Tissue Expanders

Mentor Texas is recalling 10+ models of Artoura Breast Tissue Expanders due to a risk of needle tip breakage during use.

What to do

Contact your healthcare provider if you experience difficulty during the tissue expansion process or if you have concerns regarding your implant. Surgeons should inspect infusion sets for damage prior to use and have a backup set available.

Posted
Updated
Recall No.
Z-1685-2026
Agency
Firm
Mentor Texas, LP.
Recall ID
98482
Status
ONGOING

Why it was recalled

Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.

How to identify it

UPC 00081317009450 00081317009467 00081317009542 00081317009474 00081317009481 00081317009498 00081317009504

Artoura Breast Tissue Expanders

Where it was sold

Distributed in US.

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Editorial summary by Recall Canary · last updated 2026-06-05 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification