FDA DevicesClass II
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-157LH...
Published: April 8, 2026Recall ID: Z-1682-2026Category: 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
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-157LH Smooth Low Height Tissue Expander, 650cc
Affected Products
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-157LH Smooth Low Height Tissue Expander, 650cc
Additional Source Details
| Field | Value |
|---|---|
| City | Irving |
| State | TX |
| Event id | 98482 |
| Address 1 | 3041 Skyway Cir N |
| Code info | 10081317028335 |
| 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.