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

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 1 3 3Apr 0 0 0Jul 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, LP	Device Malfunction	Nationwide
8 Apr 2026Device	CLASS II	Artoura Breast Tissue Expanders Reference Numbers recalled	Mentor Texas, LP	Device Malfunction	Nationwide
8 Apr 2026Device	CLASS II	Artoura Breast Tissue Expanders Reference Numbers recalled	Mentor Texas, LP	Device Malfunction	Nationwide
11 Mar 2026Device	CLASS II	B. Braun 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, LP	Device Malfunction	Nationwide
8 Apr 2026Device	CLASS II	Artoura Breast Tissue Expanders Reference Numbers recalled	Mentor Texas, LP	Device Malfunction	Nationwide
8 Apr 2026Device	CLASS II	Artoura Breast Tissue Expanders Reference Numbers recalled	Mentor Texas, LP	Device Malfunction	Nationwide
11 Mar 2026Device	CLASS II	B. Braun 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	E. coli	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 from recalled	Mentor Texas, LP	Sterility	Nationwide
18 Sep 2019Device	CLASS I	Ritz Princess, Biocell, Intrashiel recalled by Allergan	Allergan	Foreign Material	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.