Recall of Artoura Breast Tissue Expanders Due to Needle Issue

Source: FDA · United States

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Mentor Texas, LP. is recalling certain Artoura Breast Tissue Expanders because infusion sets may have dull or blunt needle tips that could be difficult to advance or break.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on April 15, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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What Happened

Mentor Texas, LP. is voluntarily recalling Artoura Breast Tissue Expanders due to potential issues with infusion sets that may contain dull or blunt needle tips, which could be difficult to advance and/or break.

Which Products Are Affected

The affected products are Artoura Breast Tissue Expanders with the following reference numbers: SDC-100UH, SDC-110UH, SDC-120UH, SDC-130UH, SDC-135UH, and SDC-140UH. These are Smooth Ultra High Profile Tissue Expanders in sizes 350cc, 455cc, 535cc, 650cc, 700cc, and 850cc. The recall includes UDI codes: 10081317028182, 10081317028205, 10081317028212, 10081317028229, 10081317028236, and 10081317028281. The distribution is nationwide in the United States and worldwide to countries including Canada, Albania, Australia, Austria, Belgium, Bulgaria, Croatia, Denmark, Finland, France, Germany, Iceland, Ireland, Italy, Norway, Pakistan, Poland, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, United Kingdom, and Czech Republic. The recall number is Z-1687-2026, and the product quantity is not specified.

What You Should Do

Consumers should follow the initial firm notification, which was issued via letter, and contact Mentor Texas, LP. for further instructions regarding this voluntary recall.

Why This Matters

This recall addresses potential risks associated with medical devices, classified as Class II, which may lead to temporary or reversible health issues if the needle tips fail during use.

Source

Information is from the FDA recall database, attributed to the U.S. Food and Drug Administration (FDA). For details, refer to the FDA website using the event ID 98482 or recall number Z-1687-2026.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Mentor Texas, LP. is recalling certain Artoura Breast Tissue Expanders because infusion sets may have dull or blunt needle tips that could be difficult to advance or break.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.