Mentor Texas, LP.
Medical device manufacturer in Coppell, TX.
0510(k) clearances
0PMA approvals
29recalls
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2614-2026 Class II | SYRINGE LUER LOK 10CC-200/BOX BD Product Code: 302995 Mentor Product Code: B9604…A single lot of expired syringes were distributed due to a distribution system control failure. | 04/28/2026Open, Classified |
| Z-1687-2026 Class II | Artoura Breast Tissue Expanders Reference Numbers: SDC-100UH SDC-110UH SDC-120UH…Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. | 02/18/2026Open, Classified |
| Z-1686-2026 Class II | Artoura Breast Tissue Expanders Reference Numbers: SDC-100H SDC-110H SDC-120H SDC-130H…Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. | 02/18/2026Open, Classified |
| Z-1685-2026 Class II | Artoura Breast Tissue Expanders Reference Numbers: TEXP110RH TEXP120RH TEXP120RUH…Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. | 02/18/2026Open, Classified |
| Z-1684-2026 Class II | CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-113TH…Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. | 02/18/2026Open, Classified |
| Z-1683-2026 Class II | CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-107MH…Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. | 02/18/2026Open, Classified |
| Z-1682-2026 Class II | CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-157LH Smooth…Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. | 02/18/2026Open, Classified |
| Z-1681-2026 Class II | CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313…Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. | 02/18/2026Open, Classified |
| Z-0367-2022 Class II | MENTOR Saline-Filled Breast Implants are constructed from room temperature vulcanized…Due to a manufacturing issue, Implant may have a potentially weakened area on the base patch portion of the… | 09/30/2021Open, Classified |
| Z-2070-2017 Class II | Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product…Missing Dome Pack accessory. | 03/27/2017Terminated |
| Z-2781-2016 Class II | CPX4 Breast Tissue Expander 650 cc : Product Usage: Tissue expanders can be used for…The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box. | 08/09/2016Terminated |
| Z-2780-2016 Class II | Artoura Breast Tissue Expander 700 cc Product Usage: Tissue expanders can be used for…The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box. | 08/09/2016Terminated |
| Z-2748-2016 Class II | MENTOR 2" Tall Height TE With Sutures 450cc PN: 354-9313 The MENTOR CPX4 and CPX4 with…Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc | 08/09/2016Terminated |
| Z-2747-2016 Class II | MENTOR 2" Tall Height TE With Sutures 350cc PN: 354-9312 The MENTOR CPX4 and CPX4 with…Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc | 08/09/2016Terminated |
| Z-2326-2016 Class II | Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and…The box of 300cc MemoryGel Breast Implant was labeled with null manufacturing and expiration dates. | 07/01/2016Terminated |
| Z-0964-2015 Class II | MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Breast…The IFU provided in the affected units of the MENTOR MemoryGel Resterilizable Sizer is incorrect. Those… | 12/11/2014Terminated |
| Z-2591-2014 Class II | EN MENTOR Round High Profile Single Use Saline Breast Implant Sizer Single Use Saline…The device labeling is stamped with 330cc and the device is actually 380cc device. | 07/02/2014Terminated |
| Z-0407-2009 | Mentor Aseptic Transfer Set, Cat. #350-8400 (contains BD 60mL Luer-Lok Syringe). Aseptic…The Mentor Aseptic Transfer Set contains a component, the BD 60mL Luer-Lok Syringe, which is under recall by… | 08/22/2008Terminated |
| Z-1799-2008 | Contour Genesis Aspiration Tubing, 12'; Part Number CG-PT-5558; distributed by Mentor…During packaging integrity validation, it was found that various product packages could fail, compromising… | 04/21/2008Terminated |
| Z-1798-2008 | Contour Genesis Inf/IR Tubing; Part Number CG-UT; distributed by Mentor Texas, LP…During packaging integrity validation, it was found that various product packages could fail, compromising… | 04/21/2008Terminated |
| Z-1797-2008 | Contour Genesis Infiltration Tubing, 13'; Part Number CG-INF-T; distributed by Mentor…During packaging integrity validation, it was found that various product packages could fail, compromising… | 04/21/2008Terminated |
| Z-1796-2008 | Psi-Tec Syringe Pump Infiltration Tubing, 10'; 10/box; Part Number PT-INF-T; distributed…During packaging integrity validation, it was found that various product packages could fail, compromising… | 04/21/2008Terminated |
| Z-1795-2008 | Irrigation Tubing, 25'; Part Number 5120-25; distributed by Mentor Texas, LP, Irving, TX…During packaging integrity validation, it was found that various product packages could fail, compromising… | 04/21/2008Terminated |
| Z-1794-2008 | Y Tubing Set, 9'; 10/box; Part Number LAM-Y; distributed by Mentor Texas, LP, Irving, TX…During packaging integrity validation, it was found that various product packages could fail, compromising… | 04/21/2008Terminated |
| Z-1793-2008 | Lamis Tubing Set, 9'; 10/box; Part Number LAM-TUBING; distributed by Mentor Texas, LP…During packaging integrity validation, it was found that various product packages could fail, compromising… | 04/21/2008Terminated |
| Z-1792-2008 | Hi-Vac Tubing, 8'; 10/box; Part Number B-5558; distributed by Mentor Texas, LP, Irving…During packaging integrity validation, it was found that various product packages could fail, compromising… | 04/21/2008Terminated |
| Z-1791-2008 | Autofuse Tubing, DIS SI; Part Number AFTU-DS; distributed by Mentor Texas, LP, Irving…During packaging integrity validation, it was found that various product packages could fail, compromising… | 04/21/2008Terminated |
| Z-1790-2008 | Psi-Tec Tubing, 12'; 10/box; Part Number PT-5558; distributed by Mentor Texas, LP…During packaging integrity validation, it was found that various product packages could fail, compromising… | 04/21/2008Terminated |
| Z-1230-2007 | 5mm x 30cm Hollow "Golf" Tip Ultrasonic Aspiration Probe, Model 5620-530, Catalog Number…Mis-identified and mis-labeled surgical probes were distributed. 5mm x 30cm Hollow "Golf" Tip Ultrasonic… | 07/27/2007Terminated |