McGhan Round Breast Implant, Saline-Filled BIOCELL textured. McGhan Shaped Breast Implant Saline Filled BIOCELL textured. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
McGhan Round Breast Implant, Saline-Filled BIOCELL textured. McGhan Shaped Breast Implant Saline Filled BIOCELL textured.
Lot Codes / Batch Numbers
27-168391 27-363170LF
Products Sold
27-168391 27-363170LF
A medical device manufacturer is recalling McGhan Round Breast Implant, Saline-Filled BIOCELL textured. McGhan Shaped Breast Implant Saline Fi due to Labeling mixup.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Labeling mixup.
Recommended Action
Per FDA guidance
Implants were requested back by telephone. They were returned at the firm''s expense. Recall is complete.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026