Facility

MENTOR

9 recall(s) on record — most severe on record: Class II.

Key facts

9recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	1000118360
Establishment type	Manufacture Medical Device
Location	3041 SKYWAY CIRCLE NORTH IRVING, TX, US 75038
Registration status	Active · expires 2026
Parent company	MENTOR Texas, LP (owner-operator 2125050)
Brand names	MENTOR MemoryGel Resterilizable Gel Breast Implant Sizer; MENTOR MemoryGel Enhance Single Use Gel Sizer; MENTOR MemoryShape Resterilizable Gel Breast Implant Sizer

Activity by year

Recalls (9)

Devices registered here (1)

Mammary Sizer
Product code MRD (opens in a new tab) · Unclassified · Unknown

Recalls & enforcement

Class IIOngoing2026-04-28
A single lot of expired syringes were distributed due to a distribution system control failure.
Class IIOngoing2026-02-18
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Class IIOngoing2021-09-30
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.
Class IITerminated2017-03-27
Missing Dome Pack accessory.
Class IITerminated2016-08-09
Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc
Class IITerminated2016-08-09
The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box.
Class IITerminated2016-07-01
The box of 300cc MemoryGel Breast Implant was labeled with null manufacturing and expiration dates.
Class IITerminated2014-12-11
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.
Class IITerminated2014-07-02
The device labeling is stamped with 330cc and the device is actually 380cc device.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “MENTOR (FEI 1000118360) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000118360-mentor/

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