Recall of CPX 4 US Breast Tissue Expanders Issued by FDA
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 recalling CPX 4 US Breast Tissue Expanders due to potential issues with infusion sets that may have dull or blunt needle tips, making them difficult to advance or prone to breaking.
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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Mentor Texas, LP. is recalling the product because infusion sets may contain dull or blunt needle tips, which may be difficult to advance and/or break.
Which Products Are Affected
The affected product is CPX 4 US Breast Tissue Expanders with Suture Tabs, specifically the Reference Number SCPX-157LH Smooth Low Height Tissue Expander, 650cc. The recall number is Z-1682-2026. Distribution was 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. No specific quantities or UPCs were provided.
What You Should Do
Consumers should refer to the initial firm notification, which was a letter, and contact the recalling firm, Mentor Texas, LP., for further instructions regarding this voluntary recall.
Why This Matters
This recall involves a Class II classification, indicating potential temporary or reversible health consequences due to the needle issue, affecting medical devices distributed nationwide and internationally.
Source
This information is from the FDA recall notice with event ID 98482, available through the FDA's official resources.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,358 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to April 15, 2026.
Frequently Asked Questions
Common questions about this FDA recall.