Mentor Texas recalls
Mentor Texas appears in 17 official U.S. recall notices indexed by RecallRadar, most recently on 2026-07-08.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 17 |
|---|---|
| Published | 2014-09-10 to 2026-07-08 |
| By agency | FDA Device (17) |
| By classification | Class II (17) |
| By status | ongoing (9), terminated (8) |
| Distribution named in notices | CA, CO, CT, FL, GA, IL, IN, KS, MA, ME, MI, NC, NJ, NY, OH, OK, OR, PA, RI, TN, TX, US, WA, WI, WV |
Recalls
- SYRINGE LUER LOK 10CC-200/BOX BD Product Code: 302995 Mentor Product Code: B9604 Syringe, Piston
FDA Device · Class II · 2026-07-08 · Mentor Texas
Reason: A single lot of expired syringes were distributed due to a distribution system control failure. - Artoura Breast Tissue Expanders Reference Numbers: TEXP110RH TEXP120RH TEXP120RUH TEXP130RH TEXP135RH TEXP140RH TEXP150RH Textured, High &…
FDA Device · Class II · 2026-04-08 · Mentor Texas
Reason: Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. - CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-157LH Smooth Low Height Tissue Expander, 650cc
FDA Device · Class II · 2026-04-08 · Mentor Texas
Reason: Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. - CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-113TH, SCPX-123TH, SCPX-140TH, SCPX-146TH Smooth Tall Height Tiss…
FDA Device · Class II · 2026-04-08 · Mentor Texas
Reason: Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. - Artoura Breast Tissue Expanders Reference Numbers: SDC-100H SDC-110H SDC-120H SDC-130H SDC-135H SDC-140H SDC-150H SDC-155H Smooth High Prof…
FDA Device · Class II · 2026-04-08 · Mentor Texas
Reason: Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. - CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313, 354-9314 SILTEX Low Height Tissue Expander Style (9…
FDA Device · Class II · 2026-04-08 · Mentor Texas
Reason: Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. - Artoura Breast Tissue Expanders Reference Numbers: SDC-100UH SDC-110UH SDC-120UH SDC-130UH SDC-135UH SDC-140UH Smooth Ultra High Profile Ti…
FDA Device · Class II · 2026-04-08 · Mentor Texas
Reason: Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. - CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-107MH, SCPX-117MH,SCPX-127MH, SCPX-135MH, SCPX-146MH, SCPX-156MH…
FDA Device · Class II · 2026-04-08 · Mentor Texas
Reason: Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. - MENTOR Saline-Filled Breast Implants are constructed from room temperature vulcanized silicone elastomer, made of polydimethylsiloxane
FDA Device · Class II · 2021-12-22 · Mentor Texas
Reason: Due to a manufacturing issue, Implant may have a potentially weakened area on the base patch portion of the implant which may cause leakage/deflation of the affected device. - Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048
FDA Device · Class II · 2017-05-17 · Mentor Texas
Reason: Missing Dome Pack accessory. - Artoura Breast Tissue Expander 700 cc Product Usage: Tissue expanders can be used for breast reconstruction after mastectomy, correction of…
FDA Device · Class II · 2016-09-21 · Mentor Texas
Reason: The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box. - CPX4 Breast Tissue Expander 650 cc : Product Usage: Tissue expanders can be used for breast reconstruction after mastectomy, correction of…
FDA Device · Class II · 2016-09-21 · Mentor Texas
Reason: The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box. - MENTOR 2" Tall Height TE With Sutures 450cc PN: 354-9313 The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expanders are used for bre…
FDA Device · Class II · 2016-09-14 · Mentor Texas
Reason: Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc - MENTOR 2" Tall Height TE With Sutures 350cc PN: 354-9312 The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expanders are used for bre…
FDA Device · Class II · 2016-09-14 · Mentor Texas
Reason: Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc - Mentor MemoryGel Breast Implant
FDA Device · Class II · 2016-08-10 · Mentor Texas
Reason: The box of 300cc MemoryGel Breast Implant was labeled with null manufacturing and expiration dates. - MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Breast prosthesis sizer
FDA Device · Class II · 2015-01-21 · Mentor Texas
Reason: The IFU provided in the affected units of the MENTOR MemoryGel Resterilizable Sizer is incorrect. Those units include the IFU for the MENTOR MemoryShape Resterilizable Sizer. - EN MENTOR Round High Profile Single Use Saline Breast Implant Sizer Single Use Saline Breast Implant Sizer REF 351-3380SZ 380 cc LOT 6830722
FDA Device · Class II · 2014-09-10 · Mentor Texas
Reason: The device labeling is stamped with 330cc and the device is actually 380cc device.