Mentor Texas LP
United Statesfrom the FDA registration address FDA establishment FEI 3006165545
Mentor Texas LP is a medical device manufacturer, with 1,280 devices listed in FDA GUDID and EUDAMED (FDA Unclassified, Class III, Class II and Class I) and 17 FDA recalls as of 12 Nov 2026.
- Devices
- 1,280
- Registrations
- FDA
- FDA recalls
- 179 ongoing
Registry facts
- Registries
- FDA GUDID 1,280
- EUDAMED 84
- Device classes
- FDA Unclassified 569
- FDA Class III 565
- FDA Class II 130
- FDA Class I 16
- FDA recalls
- Identifiers
- FDA FEI 3006165545
What Mentor Texas LP makes
Mentor Texas LP manufactures breast implants, including silicone gel-filled and saline-filled varieties with smooth or textured surfaces, as well as reusable and single-use breast implant sizers. The company also produces tissue expanders, liposuction system cannulas, and surgical irrigation/aspiration tubing sets.
The devices in Mentor Texas LP's portfolio are classified as Class I, Class II, and Class III medical devices and are listed in the FDA's Global Unique Device Identification Database (FDA UDI).
Catalogue
Search and filter all 1,280 devicesShowing 1-50 of 1,280
Company details
- FDA FEI number
- 3006165545
- Address
- 555 Airline Drive, Coppell, TX, 75019
FDA recalls
FDA recall records list 17 recalls initiated by Mentor Texas LP, the earliest on 2014-07-02 and the most recent on 2026-04-28. By recorded status: 9 ongoing and 8 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination, packaging, mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 1
- 2018 0
- 2019 0
- 2020 0
- 2021 1
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 8
2026
- 28 Apr 2026 Z-2614-2026 Class II Ongoing A single lot of expired syringes were distributed due to a distribution system control failure.
- 18 Feb 2026 Z-1681-2026 Class II Ongoing Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
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- 18 Feb 2026 Z-1682-2026 Class II Ongoing Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
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- 18 Feb 2026 Z-1683-2026 Class II Ongoing Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
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- 18 Feb 2026 Z-1684-2026 Class II Ongoing Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
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- 18 Feb 2026 Z-1685-2026 Class II Ongoing Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
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- 18 Feb 2026 Z-1686-2026 Class II Ongoing Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
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- 18 Feb 2026 Z-1687-2026 Class II Ongoing Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
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2021
- 30 Sep 2021 Z-0367-2022 Class II Ongoing 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.
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- 30 Sep 2021 Z-0367-2022 Class II Ongoing 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.
2017
- 27 Mar 2017 Z-2070-2017 Class II Terminated Missing Dome Pack accessory.
Show all 17 recalls
2016
- 9 Aug 2016 Z-2747-2016 Class II Terminated Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc
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- 9 Aug 2016 Z-2748-2016 Class II Terminated Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc
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- 9 Aug 2016 Z-2780-2016 Class II Terminated The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box.
- 9 Aug 2016 Z-2781-2016 Class II Terminated The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box.
- 1 Jul 2016 Z-2326-2016 Class II Terminated The box of 300cc MemoryGel Breast Implant was labeled with null manufacturing and expiration dates.
- 9 Aug 2016 Z-2747-2016 Class II Terminated Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc
2014
- 11 Dec 2014 Z-0964-2015 Class II Terminated 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.
- 2 Jul 2014 Z-2591-2014 Class II Terminated The device labeling is stamped with 330cc and the device is actually 380cc device.
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Frequently asked questions
How many devices does Mentor Texas LP have in the registry?
The registry currently lists 1280 devices for Mentor Texas LP. Devices recorded under merged duplicate company entries are counted once.
Which registries list Mentor Texas LP's devices?
Among its 50 most recently registered devices, Mentor Texas LP has devices listed in FDA GUDID (50 devices).
What risk classes do Mentor Texas LP's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Mentor Texas LP's devices are Class II and Class III. Each device page shows its own class and authorisation.
Are there FDA recall records for Mentor Texas LP?
FDA recall records list 17 recalls initiated by Mentor Texas LP, the most recent initiated on 28 Apr 2026. 9 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Mentor Texas LP in the registry?
The most recently registered devices listed for Mentor Texas LP include MENTOR Tissue Expander 350-4309MD, MENTOR Tissue Expander 350-4301MD, MENTOR Tissue Expander 350-4302MD and MENTOR Tissue Expander 350-4303MD.