Breast Implants recalls

29 medical device recalls in the breast implants category are on file with the FDA, from 2014 to 8 Apr 2026. The leading reason is foreign material.

Total recalls29since 2014

Last 12 months7reported

Class I1138% of total

Ongoing20latest 8 Apr 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 1Feb 3 3 0May 0 0 0Aug 0 0

Severity split

Class I 11 38%Class II 18 62%Class III 0 0%

Why breast implants is recalled

Companies

By year

2026724%
202313%
202113%
20191241%
201713%
2016310%
2015310%
201413%

Ongoing breast implants recalls

20 active

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
11 Mar 2026Device	CLASS II	B. Braun Winged INF SET recalled by B Braun Medical	B Braun Medical	Device Malfunction	Nationwide

All breast implants recalls, newest first

29 total

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
11 Mar 2026Device	CLASS II	B. Braun Winged INF SET recalled by B Braun Medical	B Braun Medical	Device Malfunction	Nationwide
25 Feb 2026Device	CLASS II	Medline Convenience Kits: Plastic Bin W/Misc Kits recalled	Medline Industries	Sterility	Nationwide
15 Nov 2023Device	CLASS II	Allergan Universal Fill Kit recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
22 Dec 2021Device	CLASS II	Mentor Saline-Filled Breast Implants are constructed recalled	Mentor Texas	Packaging Defects	Nationwide
18 Sep 2019Device	CLASS I	Ritz Princess, Biocell, Intrashiel recalled by Allergan	Allergan	Foreign Material	Nationwide
18 Sep 2019Device	CLASS I	McGhan BioDIMENSIONAL silicone-Filled Breast Implants, style recalled	Allergan	Foreign Material	Nationwide
18 Sep 2019Device	CLASS I	Natrelle 410, Highly Cohesive Anatomically Shaped recalled by Allergan	Allergan	Foreign Material	Nationwide
18 Sep 2019Device	CLASS I	Natrelle and McGhan Silicone-Filled Breast Implant BioCell recalled	Allergan	Foreign Material	Nationwide
18 Sep 2019Device	CLASS I	McGhan Croissant-Shaped Tissue Expanders, Style recalled by Allergan	Allergan	Foreign Material	Nationwide
18 Sep 2019Device	CLASS I	Natrelle and McGhan Silicone-Filled Breast Implants recalled by Allergan	Allergan	Foreign Material	Nationwide
18 Sep 2019Device	CLASS I	Natrelle Inspira, Silicone-Filled Breast Implants, Sterile recalled	Allergan	Foreign Material	Nationwide
18 Sep 2019Device	CLASS I	Natrelle and McGhan 410 TruForm recalled by Allergan	Allergan	Foreign Material	Nationwide
18 Sep 2019Device	CLASS I	Natrelle 150 Full Height and Short Height Implants, Biocell recalled	Allergan	Foreign Material	Nationwide
18 Sep 2019Device	CLASS I	Komuro, Soft Touch, Biocell, Intrashiel recalled by Allergan	Allergan	Foreign Material	Nationwide
18 Sep 2019Device	CLASS I	Natrelle, Saline-Filled Breast Implant Biocell Full Height recalled	Allergan	Foreign Material	Nationwide
14 Aug 2019Device	CLASS II	Structured Breast Implant, saline breast implant recalled	Ideal Implant	Packaging Defects	Nationwide
17 May 2017Device	CLASS II	Mentor Smooth Round Spectrum Post- Operatively Adjustable recalled	Mentor Texas	Other	9 states
21 Sep 2016Device	CLASS II	Artoura Breast Tissue Expander 700 cc recalled by Mentor Texas, LP	Mentor Texas	Packaging Defects	Nationwide
21 Sep 2016Device	CLASS II	CPX4 Breast Tissue Expander 650 cc recalled by Mentor Texas, LP	Mentor Texas	Packaging Defects	Nationwide
10 Aug 2016Device	CLASS II	Mentor MemoryGel Breast Implant recalled by Mentor Texas, LP	Mentor Texas	Other	11 states
29 Jul 2015Device	CLASS II	Natrelle CUI Series Tissue Expanders recalled by Allergan	Allergan	Device Malfunction	CA
29 Jul 2015Device	CLASS II	Natrelle 133 Series Tissue Expanders recalled by Allergan	Allergan	Other	CA
15 Jul 2015Device	CLASS II	Natrelle Re-sterilizable Breast Implant Sizer, Size: 410 cc recalled	Allergan	Packaging Defects	5 states
10 Sep 2014Device	CLASS II	EN Mentor Round High Profile Single Use Saline Breast recalled	Mentor Texas	Other	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.