FDA Enforcement
Class II
Ongoing
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
Recall: Z-1687-2026
·
Reported April 8, 2026
Enforcement
- Recall Number
- Z-1687-2026
- Event ID
- 98482
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Mentor Texas, LP.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 8, 2026
- Initiation Date
- February 18, 2026
- Classification Date
- March 27, 2026
- Address
- 3041 Skyway Cir N, Irving, TX, 75038-3524, United States
Description
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
Reason
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Code Info
UDI(s): 10081317028182 10081317028205 10081317028212 10081317028229 10081317028236 10081317028281
Distribution
Worldwide distribution - US Nationwide and the countries of 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, Czech Republic.