FDA Recall of Artoura Breast Tissue Expanders Due to Needle Issues
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The FDA has announced a voluntary recall of 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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FDA Recall of Artoura Breast Tissue Expanders
What Happened
Mentor Texas, LP. is 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: TEXP110RH, TEXP120RH, TEXP120RUH, TEXP130RH, TEXP135RH, TEXP140RH, and TEXP150RH. These are textured, high and ultra high profile devices with an integral injection dome, available in sizes including 300cc, 375cc, 535cc, 475cc, 500cc, 600cc, and 750cc. The products are identified by UDI codes: 00081317009450, 00081317009467, 00081317009542, 00081317009474, 00081317009481, 00081317009498, and 00081317009504. The recall involves products distributed nationwide in the United States and internationally, including 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 product quantity is not specified, and the official recall number is Z-1685-2026.
What You Should Do
Consumers who have these products should follow the initial firm notification, which was issued via letter, and contact the recalling firm, Mentor Texas, LP., at their address: 3041 Skyway Cir N, Irving, TX 75038-3524, for further instructions regarding returns or refunds.
Why This Matters
This recall highlights potential risks associated with medical devices that could affect procedures, emphasizing the need for proper device functionality in healthcare settings.
Source
Information from the FDA recall notice, recall number Z-1685-2026. For more details, visit the FDA website.
Original source: FDA Official Notice ↗
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