FDA DevicesClass II
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, ...
Published: April 8, 2026Recall ID: Z-1681-2026Category: 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: 354-9113, 3549313, 354-9314 SILTEX Low Height Tissue Expander Style (9100, 450cc), (9300, 450cc), (9300, 550cc)
Affected Products
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313, 354-9314 SILTEX Low Height Tissue Expander Style (9100, 450cc), (9300, 450cc), (9300, 550cc)
Additional Source Details
| Field | Value |
|---|---|
| City | Irving |
| State | TX |
| Event id | 98482 |
| Address 1 | 3041 Skyway Cir N |
| Code info | 00081317006671 00081317006794 00081317006800 |
| 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.