MENTOR Texas, LP
9 recall(s) on record — most severe on record: Class II.
Recalls by year
- Recalls (9)
Registered facilities (2)
- Mentor Texas LP FEI 3006165545 · TX
- MENTOR FEI 1000118360 · TX
Recalls & enforcement
- Class IIOngoing2026-04-28A single lot of expired syringes were distributed due to a distribution system control failure.
- Class IIOngoing2026-02-18Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
- Class IIOngoing2021-09-30Due 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 IITerminated2017-03-27Missing Dome Pack accessory.
- Class IITerminated2016-08-09Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc
- Class IITerminated2016-08-09The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box.
- Class IITerminated2016-07-01The box of 300cc MemoryGel Breast Implant was labeled with null manufacturing and expiration dates.
- Class IITerminated2014-12-11The 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 IITerminated2014-07-02The 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. We restate the public record only — measured facts, never risk verdicts.
Cite this record
RegWarden. “MENTOR Texas, LP — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-2125050-mentor-texas-lp/
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