FDA DevicesClass II
Artoura Breast Tissue Expanders Reference Numbers: SDC-100UH SDC-110UH SDC-120U...
Published: April 8, 2026Recall ID: Z-1687-2026Category: devicesCountry: US
Reason for Recall / Hazard
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Product Description & Identification
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
Affected Products
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
Additional Source Details
| Field | Value |
|---|---|
| City | Irving |
| State | TX |
| Event id | 98482 |
| Address 1 | 3041 Skyway Cir N |
| Code info | UDI(s): 10081317028182 10081317028205 10081317028212 10081317028229 10081317028236 10081317028281 |
| Postal code | 75038-3524 |
| Report date | 20260408 |
| Product type | Devices |
| Reason for recall | Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260218 |
| Initial firm notification | Letter |
| Center classification date | 20260327 |
Overview
- Recalling FirmMentor Texas, LP.
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide 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.