Use cautionMedical device recall · FDA · Published September 30, 2021
Mentor Saline-Filled Breast Implants Recall: Potential Leakage Due to Manufacturing Issue
Mentor recalls certain saline-filled breast implants due to a potential weakened area that may cause leakage. Affected products include specific model codes and lot numbers listed in the recall notice.
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.
“Mentor Saline-Filled Breast Implants Recall: Potential Leakage Due to Manufacturing Issue.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61731-mentor-saline-filled-breast-implants-recall-potential-leakage-due-to. Based on FDA recall #Z-0367-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0367-2022%22&limit=1).
The FDA announced on September 30, 2021, that Mentor Texas LP is recalling MENTOR Saline-Filled Breast Implants due to a manufacturing issue that may cause leakage or deflation. The recall affects 28,348 implants distributed worldwide and in the United States.
How to tell if you have it
Brand: Mentor
Product: MENTOR Saline-Filled Breast Implants
UPC: 1317001171
UPC: 8131700117
The hazard
According to the FDA, a manufacturing issue may create a potentially weakened area on the base patch portion of the implant. This defect could cause the affected device to leak or deflate.
Context
GovInfoNow's records show Mentor Texas LP has two other recalls on record since February 18, 2026. Other recent recalls of similar products include ConvaTec EsteemBody Drainable Pouch Recall: Leak Risk Due to Manufacturing Issue (February 16, 2026) and Becton Dickinson Swan-Ganz Jr Catheter Recall: Leaking Hub Risk (April 8, 2026).
How to tell if you have this one
Check the product code and lot number on your implant. Affected products include specific model codes (e.g., 3501610/81317001171) and the listed lot numbers provided in the recall notice.
Brand
Mentor
Product
Mentor Texas, LP. recalls MENTOR Saline-Filled Breast Implants are constructed from room temperature vulcanized silicone elastomer, made of
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Identify your implant's model code and lot number to determine if it is affected by this recall.
Contact Mentor
Reach out to Mentor Texas LP for guidance on next steps if your implant is affected.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 49 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - U.S. Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA published this recall 3 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Is there a risk of serious injury from this recall?
The recall states a potential leakage risk, but no specific injuries have been reported. The hazard is described as a possible deflation, which may require surgical intervention.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0367-2022 (September 30, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0367-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.