FDA Recall of CPX 4 US Breast Tissue Expanders

Source: FDA · United States

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

Mentor Texas, LP. is voluntarily recalling specific CPX 4 US Breast Tissue Expanders due to potential issues with infusion sets that may have dull or blunt needle tips.

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.

For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, cpsc, Devices) map to related alerts in the same area of risk - browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.

What Happened

Mentor Texas, LP. is recalling certain breast tissue expanders because the infusion sets may contain dull or blunt needle tips, which may be difficult to advance and/or break.

Which Products Are Affected

The affected products are CPX 4 US Breast Tissue Expanders with Suture Tabs, with reference numbers 354-9113, 3549313, and 354-9314. These include SILTEX Low Height Tissue Expander styles (9100, 450cc), (9300, 450cc), and (9300, 550cc). The codes associated are 00081317006671, 00081317006794, and 00081317006800. The recall involves worldwide distribution, including US nationwide and countries such as 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 official recall number is Z-1681-2026.

What You Should Do

Consumers who have received a letter from the firm should follow the instructions provided in that notification, as this was the initial firm notification method.

Why This Matters

This recall involves medical devices used in procedures, potentially affecting patient safety due to the risk of complications from faulty infusion sets.

Source

FDA recall notice Z-1681-2026, attributed to the FDA.

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 voluntarily recalling specific CPX 4 US Breast Tissue Expanders due to potential issues with infusion sets that may have dull or blunt needle tips.
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.