Mentor Texas, LP.

Complete recall history across all FDA and CPSC categories — 9 total recalls

Mentor Texas, LP. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (9)

FDA medical device enforcement actions by Mentor Texas, LP.

Date Product Reason Class
Feb 18, 2026 Artoura Breast Tissue Expanders Reference Numbers: SDC-100UH SDC-110UH SDC-1... Infusion sets may contain dull/blunt needle tip, which may be difficult to ad... Class II
Feb 18, 2026 CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-10... Infusion sets may contain dull/blunt needle tip, which may be difficult to ad... Class II
Feb 18, 2026 Artoura Breast Tissue Expanders Reference Numbers: SDC-100H SDC-110H SDC-120... Infusion sets may contain dull/blunt needle tip, which may be difficult to ad... Class II
Feb 18, 2026 CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-15... Infusion sets may contain dull/blunt needle tip, which may be difficult to ad... Class II
Feb 18, 2026 CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-911... Infusion sets may contain dull/blunt needle tip, which may be difficult to ad... Class II
Feb 18, 2026 CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-11... Infusion sets may contain dull/blunt needle tip, which may be difficult to ad... Class II
Feb 18, 2026 Artoura Breast Tissue Expanders Reference Numbers: TEXP110RH TEXP120RH TEXP1... Infusion sets may contain dull/blunt needle tip, which may be difficult to ad... Class II
Sep 30, 2021 MENTOR Saline-Filled Breast Implants are constructed from room temperature v... Due to a manufacturing issue, Implant may have a potentially weakened area on... Class II
Mar 27, 2017 Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Impl... Missing Dome Pack accessory. Class II
Aug 9, 2016 Artoura Breast Tissue Expander 700 cc Product Usage: Tissue expanders can... The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expande... Class II
Aug 9, 2016 MENTOR 2" Tall Height TE With Sutures 350cc PN: 354-9312 The MENTOR CPX4 a... Tissue expander product mix found: CPX4 350cc was placed in a carton for the ... Class II
Aug 9, 2016 MENTOR 2" Tall Height TE With Sutures 450cc PN: 354-9313 The MENTOR CPX4 a... Tissue expander product mix found: CPX4 350cc was placed in a carton for the ... Class II
Aug 9, 2016 CPX4 Breast Tissue Expander 650 cc : Product Usage: Tissue expanders can b... The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expande... Class II
Jul 1, 2016 Mentor MemoryGel Breast Implant; Indicated for females for breast augmentatio... The box of 300cc MemoryGel Breast Implant was labeled with null manufacturing... Class II
Dec 11, 2014 MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Bre... The IFU provided in the affected units of the MENTOR MemoryGel Resterilizable... Class II
Jul 2, 2014 EN MENTOR Round High Profile Single Use Saline Breast Implant Sizer Single Us... The device labeling is stamped with 330cc and the device is actually 380cc de... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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