FDA Recall of CPX 4 US Breast Tissue Expanders
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 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, cpsc, Devices.
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 ↗
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 (1,369 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.