CLASS II Device recall · Reported 10 Aug 2016 · FDA Enforcement Report

Mentor MemoryGel Breast Implant recalled by Mentor Texas, LP

Mentor Texas is recalling Mentor MemoryGel Breast Implant, distributed in 11 states. The recall was initiated on 1 Jul 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes7316994

Quantity recalled35 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2326-2016
FDA event ID: 74565
Recalling firm: Mentor Texas, Irving, TX
Classification: Class II
Status: Terminated
Recall initiated: 1 Jul 2016
FDA classified: 3 Aug 2016
Reported: 10 Aug 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Breast Implants

Timeline

1 Jul 2016	Recall initiated by company
3 Aug 2016	Classified by FDA	+33 days
10 Aug 2016	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The box of 300cc MemoryGel Breast Implant was labeled with null manufacturing and expiration dates.

Product as listed by the FDA

Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction.

Where it was distributed

Distributed in the states of NY, WI, CA, TX, CO, NC, NJ, OH, TN, RI, and IL.

California Colorado Illinois North Carolina New Jersey New York Ohio Rhode Island Tennessee Texas Wisconsin

Questions about this recall

Why was it recalled?

The box of 300cc MemoryGel Breast Implant was labeled with null manufacturing and expiration dates.

Which lots are affected?

7316994

Where was it sold?

Distributed in the states of NY, WI, CA, TX, CO, NC, NJ, OH, TN, RI, and IL.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Mentor Texas

All 17

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8 Jul 2026Device	CLASS II	Syringe Luer Lok 10cc-200/box Bd recalled by Mentor Texas	Mentor Texas	Device Malfunction	CA, FL, PA
8 Apr 2026Device	CLASS II	Artoura Breast Tissue Expanders Reference Numbers recalled	Mentor Texas	Device Malfunction	Nationwide
8 Apr 2026Device	CLASS II	CPX 4 US Breast Tissue Expanders recalled by Mentor Texas, LP	Mentor Texas	Device Malfunction	Nationwide
8 Apr 2026Device	CLASS II	Artoura Breast Tissue Expanders Reference Numbers recalled	Mentor Texas	Device Malfunction	Nationwide
8 Apr 2026Device	CLASS II	CPX 4 US Breast Tissue Expanders recalled by Mentor Texas, LP	Mentor Texas	Device Malfunction	Nationwide

Other Breast Implants recalls

All 29

Reported	Class	Recall	Company	Reason	Where
8 Apr 2026Device	CLASS II	Artoura Breast Tissue Expanders Reference Numbers recalled	Mentor Texas	Device Malfunction	Nationwide
8 Apr 2026Device	CLASS II	Artoura Breast Tissue Expanders Reference Numbers recalled	Mentor Texas	Device Malfunction	Nationwide
8 Apr 2026Device	CLASS II	Artoura Breast Tissue Expanders Reference Numbers recalled	Mentor Texas	Device Malfunction	Nationwide
11 Mar 2026Device	CLASS II	BBraun Medical Winged INF recalled	B Braun Medical	Device Malfunction	Nationwide
11 Mar 2026Device	CLASS II	B. Braun Winged Infusion, Single PK recalled by B Braun Medical	B Braun Medical	Device Malfunction	Nationwide