FDA DevicesClass II
Artoura Breast Tissue Expanders Reference Numbers: TEXP110RH TEXP120RH TEXP120R...
Published: April 8, 2026Recall ID: Z-1685-2026Category: 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: TEXP110RH TEXP120RH TEXP120RUH TEXP130RH TEXP135RH TEXP140RH TEXP150RH Textured, High & Ultra High Profile, Integral Injection Dome, 300cc, 375cc, 535cc, 475cc, 500cc, 600cc, 750cc,
Affected Products
Artoura Breast Tissue Expanders Reference Numbers: TEXP110RH TEXP120RH TEXP120RUH TEXP130RH TEXP135RH TEXP140RH TEXP150RH Textured, High & Ultra High Profile, Integral Injection Dome, 300cc, 375cc, 535cc, 475cc, 500cc, 600cc, 750cc,
Additional Source Details
| Field | Value |
|---|---|
| City | Irving |
| State | TX |
| Event id | 98482 |
| Address 1 | 3041 Skyway Cir N |
| Code info | UDI(s): 00081317009450 00081317009467 00081317009542 00081317009474 00081317009481 00081317009498 00081317009504 |
| 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.