Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
EN MENTOR Round High Profile Single Use Saline Breast Implant Recalled by Mentor Texas, LP. Due to The device labeling is stamped with 330cc and...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Mentor Texas, LP. directly.
Affected Products
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.
Quantity: 34 units
Why Was This Recalled?
The device labeling is stamped with 330cc and the device is actually 380cc device.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Mentor Texas, LP.
Mentor Texas, LP. has 9 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report