CLASS I ONGOING Device recall · Reported 18 Sep 2019 · FDA Enforcement Report

Natrelle and McGhan Silicone-Filled Breast Implant BioCell recalled

Allergan is recalling Natrelle and McGhan Silicone-Filled Breast Implant BioCell Round Moderate Profile, distributed nationwide in the US. The recall was initiated on 24 Jul 2019 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesALL LOTS Product Code/UDI STYLE 110:110-090 10888628002159, 110-120 10888628002166, 110-150 10888628002173, 110-180 10888628002180, 110-210 10888628002197, 110-240 10888628002203, 110-270 10888628002210, 110-300 10888628002227, 110-330 10888628002234, 110-360 10888628002241, 110-390 10888628002258, 110-420 10888628002265, 110-450 10888628002272, 110-480 10888628002289, 110-510 10888628002296; STYLE 115:115-150 10888628002302, 115-167 10888628002319, 115-185 10888628002326, 115-203 10888628002333, 115-222 10888628002340, 115-253 10888628002357, 115-272 10888628002364, 115-290 10888628002371, 115-322 10888628002388, 115-354 10888628002395, 115-378 10888628002401, 115-401 10888628002418, 115-435 10888628002425, 115-469 10888628002432, 115-507 10888628002449, 115-547 10888628002456, 115-586 10888628002463, 115-627 10888628002470, 115-666 10888628002487, 115-716 10888628002494; STYLE 120:120-180 10888628002500, 120-220 10888628002517, 120-260 10888628002524, 120-300 10888628002531, 120-340 10888628002548, 120-400 10888628002555, 120-440 10888628002562, 120-500 10888628002579, 120-550 10888628002586, 120-600 10888628002593, 120-650 10888628002609;

Quantity recalled4,026,287 Breast Implants and Tissue Expanders Combined in total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2454-2019
FDA event ID: 83500
Recalling firm: Allergan, Irvine, CA
Classification: Class I
Status: Ongoing
Recall initiated: 24 Jul 2019
FDA classified: 11 Sep 2019
Reported: 18 Sep 2019
Type: Voluntary: Firm initiated
Customers notified by: Press Release
Reason category: Foreign Material
Device type: Breast Implants

Timeline

24 Jul 2019	Recall initiated by company
11 Sep 2019	Classified by FDA	+49 days
18 Sep 2019	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

Natrelle and McGhan Silicone-Filled Breast Implant BioCell Round Moderate Profile, Sterile, for the following style numbers: Style 110:110-090, 110-120, 110-150, 110-180, 110-210, 110-240, 110-270, 110-300, 110-330, 110-360, 110-390, 110-420, 110-450, 110-480, 110-510; Style 115 :115-150, 115-167, 115-185, 115-203, 115-222, 115-253, 115-272, 115-290, 115-322, 115-354, 115-378, 115-401, 115-435, 115-469, 115-507, 115-547, 115-586, 115-627, 115-666, 115-716; Style 120: 120-180, 120-220, 120-260, 120-300, 120-340, 120-400, 120-440, 120-500, 120-550, 120-600, 120-650; These products may have been sold under the McGhan, Inamed or NATRELLE brands. Product Usage: Breast augmentation and Breast reconstruction

Where it was distributed

Worldwide Distribution and US Nationwide All fifty (50) US States, the US Virgin Islands and Puerto Rico. (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, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY). OUS: Bermuda, Canada, Chile, Japan, Korea, Thailand, Taiwan and Vietnam.

Nationwide Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts

Questions about this recall

Why was it recalled?

Which lots are affected?

ALL LOTS Product Code/UDI STYLE 110:110-090 10888628002159, 110-120 10888628002166, 110-150 10888628002173, 110-180 10888628002180, 110-210 10888628002197, 110-240 10888628002203, 110-270 10888628002210, 110-300 10888628002227, 110-330 10888628002234, 110-360 10888628002241, 110-390 10888628002258, 110-420 10888628002265, 110-450 10888628002272, 110-480 10888628002289, 110-510 10888628002296; STYLE 115:115-150 10888628002302, 115-167 10888628002319, 115-185 10888628002326, 115-203 10888628002333, 115-222 10888628002340, 115-253 10888628002357, 115-272 10888628002364, 115-290 10888628002371, 115-322 10888628002388, 115-354 10888628002395, 115-378 10888628002401, 115-401 10888628002418, 115-435 10888628002425, 115-469 10888628002432, 115-507 10888628002449, 115-547 10888628002456, 115-586 10888628002463, 115-627 10888628002470, 115-666 10888628002487, 115-716 10888628002494; STYLE 120:120-180 10888628002500, 120-220 10888628002517, 120-260 10888628002524, 120-300 10888628002531, 120-340 10888628002548, 120-400 10888628002555, 120-440 10888628002562, 120-500 10888628002579, 120-550 10888628002586, 120-600 10888628002593, 120-650 10888628002609;

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

14 other products · FDA event 83500

This product is part of a recall event; the main page for the event is Natrelle, Saline-Filled Breast Implant Biocell Full Height recalled.

Reported	Class	Recall	Company	Reason	Where
18 Sep 2019	CLASS I	Natrelle, Saline-Filled Breast Implant Biocell Full Height recalled	Allergan	Foreign Material	Nationwide
18 Sep 2019	CLASS I	Natrelle133 Plus Tissue Expander With/Without Suture Tabs recalled	Allergan	Foreign Material	Nationwide
18 Sep 2019	CLASS I	Komuro, Soft Touch, Biocell, Intrashiel recalled by Allergan	Allergan	Foreign Material	Nationwide
18 Sep 2019	CLASS I	Natrelle 150 Full Height and Short Height Implants, Biocell recalled	Allergan	Foreign Material	Nationwide
18 Sep 2019	CLASS I	Natrelle and McGhan 410 TruForm recalled by Allergan	Allergan	Foreign Material	Nationwide
18 Sep 2019	CLASS I	Natrelle Inspira, Silicone-Filled Breast Implants, Sterile recalled	Allergan	Foreign Material	Nationwide
18 Sep 2019	CLASS I	Natrelle and McGhan Silicone-Filled Breast Implants recalled by Allergan	Allergan	Foreign Material	Nationwide
18 Sep 2019	CLASS I	McGhan Croissant-Shaped Tissue Expanders, Style recalled by Allergan	Allergan	Foreign Material	Nationwide
18 Sep 2019	CLASS I	Natrelle 133 Tissue Expanders w/Suture Tabs Biocell Full recalled	Allergan	Foreign Material	Nationwide
18 Sep 2019	CLASS I	Natrelle 133 Tissue Expanders recalled by Allergan	Allergan	Foreign Material	Nationwide
18 Sep 2019	CLASS I	Natrelle 410, Highly Cohesive Anatomically Shaped recalled by Allergan	Allergan	Foreign Material	Nationwide
18 Sep 2019	CLASS I	Natrelle 510, TruForm, Dual-Gel, Biocell, Styles LX, MX, FX recalled	Allergan	Foreign Material	Nationwide
18 Sep 2019	CLASS I	McGhan BioDIMENSIONAL silicone-Filled Breast Implants, style recalled	Allergan	Foreign Material	Nationwide
18 Sep 2019	CLASS I	Ritz Princess, Biocell, Intrashiel recalled by Allergan	Allergan	Foreign Material	Nationwide

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Other Breast Implants recalls

All 29

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