medical MODERATE Updated 2026-04-08

Mentor Texas, LP. recalls Artoura Breast Tissue Expanders Reference Numbers: SDC-100U

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Recalled Product

Artoura Breast Tissue Expanders Reference Numbers: SDC-100UH SDC-110UH SDC-120UH SDC-130UH SDC-135UH SDC-140UH Smooth Ultra High Profile Tissue Expander, 350cc, 455cc, 535cc, 650cc, 700cc, 850cc

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Hazard / Issue

Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI(s): 10081317028182 10081317028205 10081317028212 10081317028229 10081317028236 10081317028281

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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View official government recall

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