CLASS II Device recall · Reported 10 Sep 2014 · FDA Enforcement Report

EN Mentor Round High Profile Single Use Saline Breast recalled

Mentor Texas is recalling EN Mentor Round High Profile Single Use Saline Breast Implant Sizer Single Use Saline, distributed nationwide in the US. The recall was initiated on 2 Jul 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart Number (PN) 351-3380SZ Lot Number 6830722

Quantity recalled34 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-2591-2014
FDA event ID: 69022
Recalling firm: Mentor Texas, Irving, TX
Classification: Class II
Status: Terminated
Recall initiated: 2 Jul 2014
FDA classified: 4 Sep 2014
Reported: 10 Sep 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Breast Implants

Timeline

2 Jul 2014	Recall initiated by company
4 Sep 2014	Classified by FDA	+64 days
10 Sep 2014	Published in enforcement report	+6 days

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

Reason for recall

The device labeling is stamped with 330cc and the device is actually 380cc device.

Product as listed by the FDA

EN MENTOR Round High Profile Single Use Saline Breast Implant Sizer Single Use Saline Breast Implant Sizer REF 351-3380SZ 380 cc LOT 6830722. Product Usage: This product is indicated for single use for temporary insertion intraoperatively to evaluate the volume of the breast implant to be implanted.

Where it was distributed

U.S Nationwide Distribution in the states of Michigan, Maryland, Texas, New Jersey, Indiana, Nevada, Florida, California, New York, Tennessee, Pennsylvania, and Colorado.

Nationwide California Colorado Florida Indiana Maryland Michigan New Jersey Nevada New York Pennsylvania Tennessee Texas

Questions about this recall

Why was it recalled?

The device labeling is stamped with 330cc and the device is actually 380cc device.

Which lots are affected?

Part Number (PN) 351-3380SZ Lot Number 6830722

Where was it sold?

U.S Nationwide Distribution in the states of Michigan, Maryland, Texas, New Jersey, Indiana, Nevada, Florida, California, New York, Tennessee, Pennsylvania, and Colorado.

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.

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8 Apr 2026Device	CLASS II	CPX 4 US Breast Tissue Expanders recalled by Mentor Texas, LP	Mentor Texas	Device Malfunction	Nationwide
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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