FDA Recall of CPX 4 US Breast Tissue Expanders Due to Needle Issue
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
The FDA has announced a voluntary recall of specific CPX 4 US Breast Tissue Expanders because their 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 14, 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
The recall involves CPX 4 US Breast Tissue Expanders due to potential issues with infusion sets that may contain a dull or blunt needle tip, which could make them difficult to advance and/or cause them to break.
Which Products Are Affected
The affected products are CPX 4 US Breast Tissue Expanders with Suture Tabs, specifically the following reference numbers: SCPX-113TH (350cc), SCPX-123TH (450cc), SCPX-140TH (650cc), and SCPX-146TH (750cc). These are Smooth Tall Height Tissue Expanders. The associated UDI codes are: 10081317028427, 10081317028434, 10081317028458, and 10081317028465. The products were distributed worldwide, 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 recall number is Z-1684-2026, and it is a Class II classification.
What You Should Do
Consumers should follow the initial firm notification, which was issued via letter, and contact the recalling firm, Mentor Texas, LP., located at 3041 Skyway Cir N, Irving, TX 75038-3524, for further instructions on the voluntary recall.
Why This Matters
This recall affects medical devices used in procedures, potentially impacting patient safety due to the risk of needle issues during use. It highlights the importance of ensuring the reliability of medical equipment distributed worldwide.
Source
Attribution: FDA. For more information, refer to the FDA recall database using recall number Z-1684-2026.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Frequently Asked Questions
Common questions about this FDA recall.