Use caution Medical device recall · FDA · Published July 24, 2019

Allergan Natrelle Breast Implants Recall: Risk of BIA-ALCL

Allergan recalls specific saline-filled breast implants due to higher risk of anaplastic large cell lymphoma (BIA-ALCL) in patients with textured implants.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2451-2019Medical device Allergan ›

Use caution until it’s fixed

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.

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Contact the company

Recalling firmAllergan PLC2525 Dupont Dr · Irvine, CA 92612-1531

✎ GovInfoNow plain-language explainer

Allergan is recalling certain saline-filled breast implants (Natrelle Biocell Full Height) that have a textured surface. These implants may carry a higher risk of a rare type of lymphoma called BIA-ALCL, which requires medical attention if the implant is still in place. Read more at govinfonow.com/recall/67340-allergan-natrelle-breast-implants-recall-risk-of-bia-alcl.

Source Summary by GovInfoNow · govinfonow.com/recall/67340-allergan-natrelle-breast-implants-recall-risk-of-bia-alcl · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2451-2019

Cite this page

“Allergan Natrelle Breast Implants Recall: Risk of BIA-ALCL.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/67340-allergan-natrelle-breast-implants-recall-risk-of-bia-alcl. Based on FDA recall #Z-2451-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2451-2019%22&limit=1).

Allergan PLC recalled saline-filled breast implants worldwide on July 24, 2019, according to the FDA. The agency cited updated safety information regarding a higher incidence of anaplastic large cell lymphoma (BIA-ALCL) associated with textured implants.

How to tell if you have it

Brand: Allergan (also McGhan, Inamed, NATRELLE)
Product: Natrelle Saline-Filled Breast Implant Biocell Full Height with Fill Tube
Style 163: 163-360CC, 163-440CC, 163-530CC, 163-655CC, 163-780CC
Style 168: 168-120, 168-150, 168-180, 168-210, 168-240, 168-270, 168-300, 168-330, 168-360, 168-390, 168-420, 168-450, 168-480, 168-510, 168-550, 168-600, 168-650, 168-700, 168-750, 168-800
Style 363: 363LF-170, 363LF-200, 363LF-230, 363LF-260, 363LF-300, 363LF-330, 363LF-370, 363LF-410, 363LF-450, 363LF-510, 363LF-560, 363LF-620, 363LF-690
Style 468: 468-195, 468-230, 468-270, 468-300, 468-350, 468-380, 468-450, 468-495, 468-560, 468-620
Units: 4,026,287 breast implants and tissue expanders combined
Distribution: Worldwide, including all 50 U.S. states, U.S. Virgin Islands, Puerto Rico, Bermuda, Canada, Chile, Japan, Korea, Thailand, Taiwan, and Vietnam

The hazard

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

Context

GovInfoNow's records show Allergan, PLC. has 7 other recalls on record since May 24, 2018. Other recent recalls include the Dec. 30, 2020, Refresh Relieva Eye Drops recall for missing instructions and the July 6, 2020, Skin Medica Acne System recall due to subpotent drug content. Similar product recalls include the Aug. 10, 2026, AVID Medical Haylard Basic Biopsy Tray recall for sterility risk and the Dec. 15, 2025, Hologic Brevera Breast Biopsy Needle recall for particulates risk.

How to tell if you have this one

Check if your implant has a textured surface and matches the listed style numbers (e.g., 163-360CC, 168-120, 363LF-170, 468-195). Products may be sold under the Natrelle, McGhan, or Inamed brands.

Brand
Allergan
Category
Medical device

FDA recall event · 15 products

All 15 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class I
Status
Ongoing
Distribution
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.

Recall number	Product, codes & lots
Z-2451-2019	Natrelle, Saline-Filled Breast Implant Biocell Full Height with Fill Tube, Sterile, for the following style numbers: Style 163:163-360CC, 163-440CC, 163-530CC, 163-655CC, 163-780CC; Style 168:168-120,168-150,168-180,168-210,168-240,168-270,168-300,168-330,168-360,168-390,168-420,168-450,168-480,168-510,168-550,168-600, 168-650,168-700,168-750, 168-800; Style 363: 363LF-170, 363LF-200, 363LF-230, 363LF-260, 363LF-300, 363LF-330, 363LF-370, 363LF-410, 363LF-450, 363LF-510, 363LF-560, 363LF-620, 363LF-690; Syle 468: 468-195, 468-230, 468-270, 468-300, 468-350, 468-380, 468-450, 468-495, 468-560, 468-620 These products may have been sold under the McGhan, Inamed or NATRELLE brands. Product Usage: Breast augmentation and Breast reconstruction; ALL LOTS Product Code/UDI Product Style 163: 163-360/10888628000704;163-440/10888628000711;163-530/10888628000728;163-655/10888628000735;163-780/10888628000742 Product Style 168: 168-120/10888628000759;168-150/10888628000766;168-180/10888628000773;168-210/10888628000780;168-240/10888628000797;168-270/10888628000803;168-300/10888628000810;168-330/10888628000827;168-360/10888628000834;168-390/10888628000841;168-420/10888628000858;168-450/10888628000865;168-480/10888628000872;168-510/10888628000889;168-550/10888628000896;168-600/10888628000902;168-650/10888628000919;168-700/10888628000926;168-750/10888628000933;168-800/10888628000940 Style 363: 363LF-170/10888628000957;363LF-200/10888628000964;363LF-230/10888628000971;363LF-260/10888628000988;363LF-300/10888628000995;363LF-330/10888628001008;363LF-370/10888628001015;363LF-410/10888628001022;363LF-450/10888628001039;363LF-510/10888628001046; 363LF-560/10888628001053;363LF-620/10888628001060;363LF-690/10888628001077; Style 468: 468-195/10888628001084;468-230/10888628001091;468-270/10888628001107;468-300/10888628001114;468-350/10888628001121;468-380/10888628001138;468-450/10888628001145;468-495/10888628001152;468-560/10888628001169;468-620/10888628001176
Z-2452-2019	Natrelle 410, Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implant Biocell Low Height Low Projection, Sterile, for the following style numbers: Syle LL: LL-410135,LL-410180,LL-410210,LL-410240,LL-410300; Style LM: LM-410140, LM-410190, LM-410220, LM-410250, LM-410320; Style LF: LF-410125, LF-410150,LF-410175,LF-410205,LF-410240,LF-410270,LF-410310,LF-410390,LF-410440,LF-410490,LF-410540,LF-410595,LL-410135,LL-410180,LL-410210,LL-410240,LL-410300; style LX: LX-410145,LX-410175,LX-410195,LX-410225,LX-410255,LX-410290,LX-410330,LX-410365,LX-410405,LX-410455,LX-410515,LX-410570,LX-410625; Style ML: ML-410125,ML-410170,ML-410195,ML-410220,ML-410285; Style MM: MM-410160,MM-410185,MM-410215,MM-410245,MM-410280,MM-410320,MM-410360,MM-410400,MM-410450; Style MF: MF-410140MF-410165,MF-410195,MF-410225,MF-410255,MF-410295,MF-410335,MF-410375,MF-410420,MF-410470,MF-410525,MF-410580,MF-410640; Style MX: MX-410165,MX-410195,MX-410225,MX-410255,MX-410290,MX-410325,MX-410370,MX-410410,MX-410445,MX-410520,MX-410550,MX-410620,MX-410685; Style FL: FL-410140,FL-410190,FL-410220,FL-410250,FL-410320; Style FM:FM-410155,FM-410180,FM-410205,FM-410235,FM-410270,FM-410310,FM-410350,FM-410395,FM-410440,FM-410500,FM-410550,FM-410605,FM-410670; Style FF: FF-410160,FF-410185,FF-410220,FF-410255,FX-410290,FF-410335,FF-410375,FF-410425,FF-410475,FF-410535,FF-410595,FF-410655,FF-410740; Style FX: FX-410185FX-410215,FX-410245,FX-410280,FX-410315,FX-410360,FX-410410,FX-410450,FX-410495,FX-410560,FX-410615,FX-410690,FX-410775 These products may have been sold under the McGhan, Inamed or NATRELLE brands. Product Usage: Breast augmentation and Breast reconstruction; ALL LOTS Product Code/UDI Style LL: LL-410135/10888628003170,LL-410180/10888628003187,LL-410210/10888628003194,LL-410240/10888628003200,LL-410300/10888628003217; Style LM: LM-410140/10888628003224,LM-410190/10888628003231,LM-410220/10888628003248,LM-410250/10888628003255,LM-410320/10888628003262; Style LF: LF-410125/10888628003057,LF-410150/10888628003064,LF-410175/10888628003071,LF-410205/10888628003088,LF-410240/10888628003095,LF-410270/10888628003101,LF-410310/10888628003118,LF-410390/10888628003125,LF-410440/10888628003132,LF-410490/10888628003149,LF-410540/10888628003156,LF-410595/10888628003163; Style LX: LX-410145/10888628003279,LX-410175/10888628003286,LX-410195/10888628003293,LX-410225/10888628003309,LX-410255/10888628003316,LX-410290/10888628003323,LX-410330/10888628003330,LX-410365/10888628003347,LX-410405/10888628003354,LX-410455/10888628003361,LX-410515/10888628003378,LX-410570/10888628003385,LX-410625/10888628003392; Style ML: ML-410125/10888628003538,ML-410170/10888628003545,ML-410195/10888628003552,ML-410220/10888628003569,ML-410285/10888628003576; Style MM: MM-410160 10888628003583,MM-410185/10888628003590,MM-410215/10888628003606,MM-410245/10888628003613,MM-410280/10888628003620,MM-410320/10888628003637,MM-410360/10888628003644,MM-410400/10888628003651,MM-410450/10888628003668; Style MF:MF-410140/10888628003408,MF-410165/10888628003415,MF-410195/10888628003422,MF-410225/10888628003439,MF-410255/10888628003446,MF-410295/10888628003453,MF-410335/10888628003460,MF-410375/10888628003477,MF-410420/10888628003484,MF-410470/10888628003491,MF-410525/10888628003507,MF-410580/10888628003514,MF-410640/10888628003521; Style MX:MX-410165/10888628003675,MX-410195/10888628003682,MX-410225/10888628003699,MX-410255/10888628003705,MX-410290/10888628003712,MX-410325/10888628003729,MX-410370/10888628003736,MX-410410/10888628003743,MX-410445/10888628003750,MX-410520/10888628003767,MX-410550/10888628003774,MX-410620/10888628003781,MX-410685/10888628003798; Style FL: FL-410140/10888628002746,FL-410190/10888628002753,FL-410220/10888628002760,FL-410250/10888628002777,FL-410320/10888628002784; Style FM:FM-410155/10888628002791,FM-410180/10888628002807,FM-410205/10888628002814,FM-410235/10888628002821,FM-410270/10888628002838,FM-410310/10888628002845,FM-410350/10888628002852,FM-410395/10888628002869,FM-410440/10888628002876,FM-410500/10888628002883,FM-410550/10888628002890,FM-410605/10888628002906,FM-410670/10888628002913; Style FF: FF-410160/10888628002616,FF-410185/10888628002623,FF-410220/10888628002630,FF-410255/10888628002647,FF-410290/10888628002654,FF-410335/10888628002661,FF-410375/10888628002678,FF-410425/10888628002685,FF-410475/10888628002692,FF-410535/10888628002708,FF-410595/10888628002715,FF-410655/10888628002722,FF-410740/10888628002739; Style FX: FX-410185/10888628002920,FX-410215/10888628002937,FX-410245/10888628002944,FX-410280/10888628002951,FX-410315/10888628002968,FX-410360/10888628002975,FX-410410/10888628002982,FX-410450/10888628002999,FX-410495/10888628003002,FX-410560/10888628003019,FX-410615/10888628003026,FX-410690/10888628003033,FX-410775/10888628003040;
Z-2453-2019	Natrelle Inspira, Silicone-Filled Breast Implants, Sterile, for the following style numbers: Style TRL: TRL-110TRL-125,TRL-140,TRL-170,TRL-200,TRL-230,TRL-260,TRL-290,TRL-320,TRL-350,TRL-380,TRL-410,TRL-460,TRL-510,TRL-560,TRL-610; Style TRLP: TRLP-125TRLP-145,TRLP-165,TRLP-190,TRLP-205,TRLP-220,TRLP-235,TRLP-250, TRLP-265,TRLP-280,TRLP-300,TRLP-320,TRLP-340,TRLP-360,TRLP-400,TRLP-440,TRLP-490,TRLP-540,TRLP-590,TRLP-640; Style TRM: TRM-140,TRM-175,TRM-195,TRM-210,TRM-240,TRM-255,TRM-275,TRM-295,TRM-310,TRM-330,TRM-345,TRM-360,TRM-375TRM-405,TRM-445,TRM-485,TRM-520,TRM-560,TRM-600,TRM-640,TRM-685,TRM-755 Style TRF: TRF-180TRF-200,TRF-220,TRF-240,TRF-265,TRF-295,TRF-325,TRF-335,TRF-345,TRF-365,TRF-385,TRF-415,TRF-450,TRF-485,TRF-520,TRF-560,TRF-605,TRF-650,TRF-695,TRF-745,TRF-770; Style TRX: TRX-205,TRX-225,TRX-255,TRX-285,TRX-310,TRX-340,TRX-375,TRX-400,TRX-420,TRX-445,TRX-470,TRX-495,TRX-525,TRX-545,TRX-560,TRX-580,TRX-615,TRX-650,TRX-700,TRX-750,TRX-800; Style TSL: TSL-110, TSL-125, TSL-140, TSL-170, TSL-200, TSL-230, TSL-260, TSL-290, TSL-320, TSL-350, TSL-380, TSL-410, TSL-460, TSL-510, TSL-560, TSL-610; Style TSLP: TSLP-125, TSLP-145, TSLP-165, TSLP-190, TSLP-205, TSLP-220, TSLP-235, TSLP-250, TSLP-265, TSLP-280, TSLP-300, TSLP-320, TSLP-340, TSLP-360, TSLP-400, TSLP-440, TSLP-490, TSLP-540, TSLP-590, TSLP-640; Style TSM: TSM-140, TSM-175, TSM-195, TSM-210, TSM-240, TSM-255, TSM-275, TSM-295, TSM-310, TSM-330, TSM-345, TSM-360, TSM-375, TSM-405, TSM-445, TSM-485, TSM-520, TSM-560, TSM-600, TSM-640, TSM-685, TSM-755; Style TSF: TSF-180 TSF-200 TSF-220 TSF-240 TSF-265 TSF-295 TSF-325 TSF-335 TSF-345 TSF-365 TSF-385 TSF-415 TSF-450 TSF-485 TSF-520 TSF-560 TSF-605 TSF-650 TSF-695 TSF-745 TSF-770 Style TSX: TSX-205, TSX-225, TSX-255, TSX-285, TSX-310, TSX-340, TSX-375, TSX-400, TSX-420, TSX-445, TSX-470, TSX-495, TSX-525, TSX-545, TSX-560, TSX-580, TSX-615, TSX-650, TSX-700, TSX-750, TSX-800; Style TCL: TCL-110, TCL-125, TCL-140, TCL-170, TCL-200, TCL-230, TCL-260, TCL-290, TCL-320, TCL-350, TCL-380, TCL-410, TCL-460, TCL-510, TCL-560, TCL-610; Style TCLP: TCLP-125, TCLP-145, TCLP-165, TCLP-190, TCLP-205, TCLP-220, TCLP-235, TCLP-250, TCLP-265, TCLP-280, TCLP-300, TCLP-320, TCLP-340, TCLP-360, TCLP-400, TCLP-440, TCLP-490, TCLP-540, TCLP-590, TCLP-640; Style TCM: TCM-140, TCM-175, TCM-195, TCM-210, TCM-240, TCM-255, TCM-275 TCM-295 TCM-310, TCM-330, TCM-345, TCM-360, TCM-375, TCM-405, TCM-445, TCM-485, TCM-520, TCM-560, TCM-600, TCM-640, TCM-685, TCM-755; Style TCF: TCF-180 TCF-200 TCF-220 TCF-240 TCF-265 TCF-295 TCF-325 TCF-335 TCF-345 TCF-365 TCF-385 TCF-415 TCF-450 TCF-485 TCF-520 TCF-560 TCF-605 TCF-650 TCF-695 TCF-745 TCF-770 Style TCX: TCX-205, TCX-225, TCX-255, TCX-285, TCX-310, TCX-340, TCX-375, TCX-400 TCX-420, TCX-445, TCX-470, TCX-495, TCX-525, TCX-545, TCX-560, TCX-580, TCX-615, TCX-650, TCX-700, TCX-750, TCX-800; These products may have been sold under the McGhan, Inamed or NATRELLE brands. Product Usage: Breast augmentation and Breast reconstruction; ALL LOTS Product Code/UDI Style TRL: TRL-125 10888628007659, TRL-140 10888628007666, TRL-170 10888628007673, TRL-200 10888628007680, TRL-230 10888628007697, TRL-260 10888628007703, TRL-290 10888628007710, TRL-320 10888628007727, TRL-350 10888628007734, TRL-380 10888628007741, TRL-410 10888628007758, TRL-460 10888628007765, TRL-510 10888628007772, TRL-560 10888628007789, TRL-610 10888628007796; Style TRLP:TRLP-125 10888628007802, TRLP-145 10888628007819, TRLP-165 10888628007826, TRLP-190 10888628007833, TRLP-205 10888628007840, TRLP-220 10888628007857, TRLP-235 10888628007864, TRLP-250 10888628007871, TRLP-265 10888628007888, TRLP-280 10888628007895, TRLP-300 10888628007901, TRLP-320 10888628007918, TRLP-340 10888628007925, TRLP-360 10888628007932, TRLP-400 10888628007949, TRLP-440 10888628007956, TRLP-490 10888628007963, TRLP-540 10888628007970, TRLP-590 10888628007987, TRLP-640 10888628007994; Style TRM TRM-140 10888628008007, TRM-175 10888628008014, TRM-195 10888628008021, TRM-210 10888628008038, TRM-240 10888628008045, TRM-255 10888628008052, TRM-275 10888628008069, TRM-295 10888628008076, TRM-310 10888628008083, TRM-330 10888628008090, TRM-345 10888628008106, TRM-360 10888628008113, TRM-375 10888628008120, TRM-405 10888628008137, TRM-445 10888628008144, TRM-485 10888628008151, TRM-520 10888628008168, TRM-560 10888628008175, TRM-600 10888628008182, TRM-640 10888628008199, TRM-685 10888628008205, TRM-755 10888628008212; Style TRF: TRF-180 10888628008229, TRF-200 10888628008236, TRF-220 10888628008243, TRF-240 10888628008250, TRF-265 10888628008267, TRF-295 10888628008274, TRF-325 10888628008281, TRF-335 10888628008298, TRF-345 10888628008304, TRF-365 10888628008311, TRF-385 10888628008328, TRF-415 10888628008335, TRF-450 10888628008342, TRF-485 10888628008359, TRF-520 10888628008366, TRF-560 10888628008373, TRF-605 10888628008380, TRF-650 10888628008397, TRF-695 10888628008403, TRF-745 10888628008410, TRF-770 10888628008427; Style TRX: TRX-205 10888628008434, TRX-225 10888628008441, TRX-255 10888628008458, TRX-285 10888628008465, TRX-310 10888628008472, TRX-340 10888628008489, TRX-375 10888628008496, TRX-400 10888628008502, TRX-420 10888628008519, TRX-445 10888628008526, TRX-470 10888628008533, TRX-495 10888628008540, TRX-525 10888628008557, TRX-545 10888628008564, TRX-560 10888628008571, TRX-580 10888628008588, TRX-615 10888628008595, TRX-650 10888628008601, TRX-700 10888628008618, TRX-750 10888628008625, TRX-800 10888628008632; Style TSL: TSL-110 10888628033474, TSL-125 10888628033481, TSL-140 10888628033498, TSL-170 10888628033504, TSL-200 10888628033511, TSL-230 10888628033528, TSL-260 10888628033535, TSL-290 10888628033542, TSL-320 10888628033559, TSL-350 10888628033566, TSL-380 10888628033573, TSL-410 10888628033580, TSL-460 10888628033597, TSL-510 10888628033603, TSL-560 10888628033610, TSL-610 10888628033627; Style TSLP: TSLP-125 10888628033634, TSLP-145 10888628033641, TSLP-165 10888628033658, TSLP-190 10888628033665, TSLP-205 10888628033672, TSLP-220 10888628033689, TSLP-235 10888628033696, TSLP-250 10888628033702, TSLP-265 10888628033719, TSLP-280 10888628033726, TSLP-300 10888628033733, TSLP-320 10888628033740, TSLP-340 10888628033757, TSLP-360 10888628033764 TSLP-400 10888628033771, TSLP-440 10888628033788, TSLP-490 10888628033795, TSLP-540 10888628033801, TSLP-590 10888628033818, TSLP-640 10888628033825; Style TSM: TSM-140 10888628033832, TSM-175 10888628033849, TSM-195 10888628033856, TSM-210 10888628033863, TSM-240 10888628033870, TSM-255 10888628033887, TSM-275 10888628033894, TSM-295 10888628033900, TSM-310 10888628033917, TSM-330 10888628033924, TSM-345 10888628033931, TSM-360 10888628033948, TSM-375 10888628033955, TSM-405 10888628033962, TSM-445 10888628033979, TSM-485 10888628033986, TSM-520 10888628033993, TSM-560 10888628034006, TSM-600 10888628034013, TSM-640 10888628034020, TSM-685 10888628034037, TSM-755 10888628034044; Style TSF: TSF-180 10888628034051, TSF-200 10888628034068, TSF-220 10888628034075, TSF-240 10888628034082, TSF-265 10888628034099, TSF-295 10888628034105, TSF-325 10888628034112, TSF-335 10888628034129, TSF-345 10888628034136, TSF-365 10888628034143, TSF-385 10888628034150, TSF-415 10888628034167, TSF-450 10888628034174, TSF-485 10888628034181, TSF-520 10888628034198, TSF-560 10888628034204, TSF-605 10888628034211, TSF-650 10888628034228, TSF-695 10888628034235, TSF-745 10888628034242, TSF-770 10888628034259; Style TSX: TSX-205 10888628034266, TSX-225 10888628034273, TSX-255 10888628034280, TSX-285 10888628034297, TSX-310 10888628034303, TSX-340 10888628034310, TSX-375 10888628034327, TSX-400 10888628034334, TSX-420 10888628034341, TSX-445 10888628034358, TSX-470 10888628034365, TSX-495 10888628034372, TSX-525 10888628034389, TSX-545 10888628034396, TSX-560 10888628034402, TSX-580 10888628034419, TSX-615 10888628034426, TSX-650 10888628034433, TSX-700 10888628034440, TSX-750 10888628034457, TSX-800 10888628034464; Style TCL: TCL-110 10888628030435, TCL-125 10888628030442, TCL-140 10888628030459, TCL-170 10888628030466, TCL-200 10888628030473, TCL-230 10888628030480, TCL-260 10888628030497, TCL-290 10888628030503, TCL-320 10888628030510, TCL-350 10888628030527, TCL-380 10888628030534, TCL-410 10888628030541, TCL-460 10888628030558, TCL-510 10888628030565, TCL-560 10888628030572, TCL-610 10888628030589; Style TCLP: TCLP-125 10888628030596, TCLP-145 10888628030602, TCLP-165 10888628030619, TCLP-190 10888628030626, TCLP-205 10888628030633, TCLP-220 10888628030640, TCLP-235 10888628030657, TCLP-250 10888628030664, TCLP-265 10888628030671, TCLP-280 10888628030688, TCLP-300 10888628030695, TCLP-320 10888628030701, TCLP-340 10888628030718, TCLP-360 10888628030725, TCLP-400 10888628030732, TCLP-440 10888628030749, TCLP-490 10888628030756, TCLP-540 10888628030763, TCLP-590 10888628030770, TCLP-640 10888628030787; Style TCM: TCM-140 10888628030794, TCM-175 10888628030800, TCM-195 10888628030817, TCM-210 10888628030824, TCM-240 10888628030831, TCM-255 10888628030848, TCM-275 10888628030855, TCM-295 10888628030862, TCM-310 10888628030879, TCM-330 10888628030886, TCM-345 10888628030893, TCM-360 10888628030909 TCM-375 10888628030916, TCM-405 10888628030923, TCM-445 10888628030930, TCM-485 10888628030947, TCM-520 10888628030954, TCM-560 10888628030961, TCM-600 10888628030978, TCM-640 10888628030985, TCM-685 10888628030992, TCM-755 10888628031005; Style TCF: TCF-180 10888628031012, TCF-200 10888628031029, TCF-220 10888628031036, TCF-240 10888628031043, TCF-265 10888628031050, TCF-295 10888628031067, TCF-325 10888628031074, TCF-335 10888628031081, TCF-345 10888628031098, TCF-365 10888628031104, TCF-385 10888628031111, TCF-415 10888628031128, TCF-450 10888628031135, TCF-485 10888628031142, TCF-520 10888628031159, TCF-560 10888628031166, TCF-605 10888628031173, TCF-650 10888628031180, TCF-695 10888628031197, TCF-745 10888628031203, TCF-770 10888628031210; Style TCX: TCX-205 10888628031227, TCX-225 10888628031234, TCX-255 10888628031241, TCX-285 10888628031258, TCX-310 10888628031265, TCX-340 10888628031272, TCX-375 10888628031289, TCX-400 10888628031296, TCX-420 10888628031302, TCX-445 10888628031319, TCX-470 10888628031326, TCX-495 10888628031333, TCX-525 10888628031340, TCX-545 10888628031357, TCX-560 10888628031364, TCX-580 10888628031371, TCX-615 10888628031388, TCX-650 10888628031395, TCX-700 10888628031401, TCX-750 10888628031418, TCX-800 10888628031425
Z-2454-2019	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; 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;
Z-2455-2019	Natrelle 133 Tissue Expanders (also named style 133 BIOSPAN Tissue Expander and Mcghan Magna-Site Tissue Expander) BioCell Full Height Variable Projection with Magna-Fider Xact & 21G Needle Infusion Set, Sterile, for the following style numbers: STYLE 133FV: 133FV-11, 133FV-12, 133FV-13, 133FV-14, 133FV-15, 133FV-16; STYLE 133MV: 133MV-11, 133MV-12, 133MV-13, 133MV-14, 133MV-15, 133MV-16; STYLE 133LV: 133LV-11, 133LV-12, 133LV-13, 133LV-14, 133LV-15, 133LV-16; STYLE 133FX: 133FX-11 133FX-12 133FX-13 133FX-14 133FX-15 133FX-16 STYLE 133MX: 133MX-11, 133MX-12, 133MX-13, 133MX-14, 133MX-15, 133MX-16; STYLE 133SX: 133SX-11, 133SX-12, 133SX-13, 133SX-14, 133SX-15, 133SX-16; STYLE 133SV: 133SV-11, 133SV-12, 133SV-13, 133SV-14, 133SV-15, 133SV-16; These products may have been sold under the McGhan, Inamed or NATRELLE brands. Product Usage: intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline for injection until the desired amount of tissue is developed.; ALL LOTS Product Code/UDI STYLE 133FV: 133FV-11 10888628003927, 133FV-12 10888628003934, 133FV-13 10888628003941, 133FV-14 10888628003958, 133FV-15 10888628003965, 133FV-16 10888628003972; STYLE 133MV: 133MV-11 10888628004108, 133MV-12 10888628004115, 133MV-13 10888628004122, 133MV-14 10888628004139, 133MV-15 10888628004146, 133MV-16 10888628004153; STYLE 133LV: 133LV-11 10888628004047, 133LV-12 10888628004054, 133LV-13 10888628004061, 133LV-14 10888628004078, 133LV-15 10888628004085, 133LV-16 10888628004092; STYLE 133FX: 133FX-11 10888628003989, 133FX-12 10888628003996, 133FX-13 10888628004009, 133FX-14 10888628004016, 133FX-15 10888628004023, 133FX-16 10888628004030; STYLE 133MX: 133MX-11 10888628004160, 133MX-12 10888628004177, 133MX-13 10888628004184, 133MX-14 10888628004191, 133MX-15 10888628004207, 133MX-16 10888628004214; STYLE 133SX: 133SX-11 10888628003804, 133SX-12 10888628003811, 133SX-13 10888628003828, 133SX-14 10888628003835, 133SX-15 10888628003842, 133SX-16 10888628003859; STYLE 133SV: 133SV-11 10888628003866, 133SV-12 10888628003873, 133SV-13 10888628003880, 133SV-14 10888628003897, 133SV-15 10888628003903, 133SV-16 10888628003910;
Z-2456-2019	Natrelle133 Plus Tissue Expander With/Without Suture Tabs, BioCell Full Height Variable Projection with Magna-Fider Xact & 21G Needle Infusion Set, Sterile, for the following style numbers: STYLE 133P-FV: 133P-FV-11, 133P-FV-12, 133P-FV-13, 133P-FV-14, 133P-FV-15, 133P-FV-16; STYLE 133P-MV: 133P-MV-11, 133P-MV-12, 133P-MV-13, 133P-MV-14, 133P-MV-15, 133P-MV-16; STYLE 133P-LV: 133P-LV-11, 133P-LV-12, 133P-LV-13, 133P-LV-14, 133P-LV-15, 133P-LV-16; STYLE 133P-FX: 133P-FX-11, 133P-FX-12, 133P-FX-13, 133P-FX-14, 133P-FX-15, 133P-FX-16; STYLE 133P-MX:133P-MX-11,133P-MX-12, 133P-MX-13, 133P-MX-14, 133P-MX-15, 133P-MX-16; STYLE 133P-SX: 133P-SX-11, 133P-SX-12, 133P-SX-13, 133P-SX-14, 133P-SX-15, 133P-SX-16; STYLE 133P-SV: 133P-SV-11,133P-SV-12, 133P-SV-13, 133P-SV-14, 133P-SV-15, 133P-SV-16; STYLE 133P-FV-T:133P-FV-11-T, 133P-FV-12-T, 133P-FV-13-T, 133P-FV-14-T, 133P-FV-15-T, 133P-FV-16-T; STYLE 133P-MV-T: 133P-MV-11-T, 133P-MV-12-T, 133P-MV-13-T, 133P-MV-14-T, 133P-MV-15-T, 133P-MV-16-T; STYLE 133P-LV-T: 133P-LV-11-T, 133P-LV-12-T, 133P-LV-13-T, 133P-LV-14-T, 133P-LV-15-T, 133P-LV-16-T; STYLE 133P-FX-T: 133P-FX-11-T, 133P-FX-12-T, 133P-FX-13-T, 133P-FX-14-T, 133P-FX-15-T, 133P-FX-16-T; STYLE 133P-MX-T: 133P-MX-11-T, 133P-MX-12-T, 133P-MX-13-T, 133P-MX-14-T, 133P-MX-15-T, 133P-MX-16-T; STYLE 133P-SX-T: 133P-SX-11-T, 133P-SX-12-T, 133P-SX-13-T, 133P-SX-14-T, 133P-SX-15-T, 133P-SX-16-T; STYLE 133P-SV-T: 133P-SV-11-T, 133P-SV-12-T, 133P-SV-13-T, 133P-SV-14-T, 133P-SV-15-T, 133P-SV-16-T These products may have been sold under the McGhan, Inamed or NATRELLE brands. Product Usage: intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline for injection until the desired amount of tissue is developed; ALL LOTS; Product Code/UDI STYLE 133P-FV:133P-FV-11 10888628009646, 133P-FV-11-T 10888628009653, 133P-FV-12 10888628009660, 133P-FV-12-T 10888628009677, 133P-FV-13 10888628009684, 133P-FV-13-T 10888628009691, 133P-FV-14 10888628009707, 133P-FV-14-T 10888628009714, 133P-FV-15 10888628009721, 133P-FV-15-T 10888628009738, 133P-FV-16 10888628009745; STYLE 133P-MV: 133P-MV-11 10888628010000, 133P-MV-12 10888628010024, 133P-MV-13 10888628010048, 133P-MV-14 10888628010062, 133P-MV-15 10888628010086, 133P-MV-16 10888628010109; STYLE 133P-LV: 133P-LV-11 10888628009882, 133P-LV-12 10888628009905, 133P-LV-13 10888628009929, 133P-LV-14 10888628009943, 133P-LV-15 10888628009967, 133P-LV-16 10888628009981; STYLE 133P-FX: 133P-FX-11 10888628009769, 133P-FX-12 10888628009783, 133P-FX-13 10888628009806, 133P-FX-14 10888628009820, 133P-FX-15 10888628009844, 133P-FX-16 10888628009868; STYLE 133P-MX: 133P-MX-11 10888628010123, 133P-MX-12 10888628010147, 133P-MX-13 10888628010161, 133P-MX-14 10888628010185, 133P-MX-15 10888628010208, 133P-MX-16 10888628010222; STYLE 133P-SX: 133P-SX-11 10888628010369, 133P-SX-12 10888628010383, 133P-SX-13 10888628010406, 133P-SX-14 10888628010420, 133P-SX-15 10888628010444, 133P-SX-16 10888628010468; STYLE 133P-SV: 133P-SV-11 10888628010246, 133P-SV-12 10888628010260, 133P-SV-13 10888628010284, 133P-SV-14 10888628010307, 133P-SV-15 10888628010321, 133P-SV-16 10888628010345; STYLE 133P-FV-T: 133P-FV-11-T 10888628009653, 133P-FV-12-T 10888628009677, 133P-FV-13-T 10888628009691, 133P-FV-14-T 10888628009714, 133P-FV-15-T 10888628009738, 133P-FV-16-T 10888628009752; STYLE 133P-MV-T: 133P-MV-11-T 10888628010017, 133P-MV-12-T 10888628010031, 133P-MV-13-T 10888628010055, 133P-MV-14-T 10888628010079, 133P-MV-15-T 10888628010093, 133P-MV-16-T 10888628010116; STYLE 133P-LV-T: 133P-LV-11-T 10888628009899, 133P-LV-12-T 10888628009912, 133P-LV-13-T 10888628009936, 133P-LV-14-T 10888628009950, 133P-LV-15-T 10888628009974, 133P-LV-16-T 10888628009998; STYLE 133P-FX-T: 133P-FX-11-T 10888628009776, 133P-FX-12-T 10888628009790, 133P-FX-13-T 10888628009813, 133P-FX-14-T 10888628009837, 133P-FX-15-T 10888628009851, 133P-FX-16-T 10888628009875; STYLE 133P-MX-T: 133P-MX-11-T 10888628010130, 133P-MX-12-T 10888628010154, 133P-MX-13-T 10888628010178, 133P-MX-14-T 10888628010192, 133P-MX-15-T 10888628010215, 133P-MX-16-T 10888628010239; STYLE 133P-SX-T: 133P-SX-11-T 10888628010376, 133P-SX-12-T 10888628010390, 133P-SX-13-T 10888628010413, 133P-SX-14-T 10888628010437, 133P-SX-15-T 10888628010451, 133P-SX-16-T 10888628010475; STYLE 133P-SV-T: 133P-SV-11-T 10888628010253, 133P-SV-12-T 10888628010277, 133P-SV-13-T 10888628010291, 133P-SV-14-T 10888628010314, 133P-SV-15-T 10888628010338, 133P-SV-16-T 10888628010352
Z-2457-2019	Natrelle 133 Tissue Expanders w/Suture Tabs BIOCELL Full Height Variable Projection with MAGNA-FINDEr Xact & 21G Needle Infusion Set STYLE 133FV-T: 133FV-11-T, 133FV-12-T, 133FV-13-T, 133FV-14-T, 133FV-15-T, 133FV-16-T; STYLE 133MV-T: 133MV-11-T, 133MV-12-T, 133MV-13-T, 133MV-14-T, 133MV-15-T, 133MV-16-T; STYLE 133LV-T: 133LV-11-T, 133LV-12-T, 133LV-13-T, 133LV-14-T, 133LV-15-T, 133LV-16-T; STYLE 133SV-T: 133SV-11-T, 133SV-12-T, 133SV-13-T, 133SV-14-T, 133SV-15-T, 133SV-16-T STYLE 133FX-T: 133FX-11-T, 133FX-12-T, 133FX-13-T, 133FX-14-T, 133FX-15-T, 133FX-16-T; STYLE 133MX-T: 133MX-11-T, 133MX-12-T, 133MX-13-T, 133MX-14-T, 133MX-15-T, 133MX-16-T; STYLE 133SX-T: 133SX-11-T, 133SX-12-T, 133SX-13-T, 133SX-14-T, 133SX-15-T, 133SX-16-T; Product Usage: intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline for injection until the desired amount of tissue is developed.; ALL LOTS; Product Code/UDI STYLE 133FV-T: 133FV-11-T 10888628004221, 133FV-12-T 10888628004238, 133FV-13-T 10888628004245, 133FV-14-T 10888628004252, 133FV-15-T 10888628004269, 133FV-16-T 10888628004276; STYLE 133MV-T: 133MV-11-T 10888628004405, 133MV-12-T 10888628004412, 133MV-13-T 10888628004429, 133MV-14-T 10888628004436, 133MV-15-T 10888628004443, 133MV-16-T 10888628004450; STYLE 133LV-T: 133LV-11-T 10888628004344, 133LV-12-T 10888628004351, 133LV-13-T 10888628004368, 133LV-14-T 10888628004375, 133LV-15-T 10888628004382, 133LV-16-T 10888628004399; STYLE 133FX-T: 133FX-11-T 10888628004283, 133FX-12-T 10888628004290, 133FX-13-T 10888628004306, 133FX-14-T 10888628004313, 133FX-15-T 10888628004320, 133FX-16-T 10888628004337; STYLE 133MX-T: 133MX-11-T 10888628004467, 133MX-12-T 10888628004474, 133MX-13-T 10888628004481, 133MX-14-T 10888628004498, 133MX-15-T 10888628004504, 133MX-16-T 10888628004511; STYLE 133SX-T: 133SX-11-T 10888628004580, 133SX-12-T 10888628004597, 133SX-13-T 10888628004603, 133SX-14-T 10888628004610, 133SX-15-T 10888628004627, 133SX-16-T 10888628004634; STYLE 133SV-T: 133SV-11-T 10888628004528, 133SV-12-T 10888628004535, 133SV-13-T 10888628004542, 133SV-14-T 10888628004559, 133SV-15-T 10888628004566 133SV-16-T 10888628004573
Z-2458-2019	McGhan Croissant-Shaped Tissue Expanders, Style 134 Product Usage: intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline for injection until the desired amount of tissue is developed.; ALL LOTS;
Z-2459-2019	McGhan BioDIMENSIONAL silicone-Filled Breast Implants, style 153 Product Usage: Breast augmentation and Breast reconstruction; ALL LOTS;
Z-2460-2019	Natrelle and McGhan 410 TruForm 2 (Soft Touch) BIOCELL breast implant, Styles LL, LM, LF, ML, MM, MF, FL, FM, FF Product Usage: Breast augmentation and Breast reconstruction; All Lots: Note:This product was not distributed within the US
Z-2461-2019	Natrelle 510, TruForm, Dual-Gel, BIOCELL, Styles LX, MX, FX Product Usage: Breast augmentation and Breast reconstruction; All Lots: Note:This product was not distributed within the US
Z-2462-2019	Natrelle and McGhan Silicone-Filled Breast Implants, TruForm 2 (Soft Touch), BIOCELL, Styles 110 Soft Touch and 120 Soft Touch Product Usage : Breast augmentation and Breast reconstruction; All Lots: Note:This product was not distributed within the US
Z-2463-2019	Komuro, Soft Touch, BIOCELL, INTRASHIEL, BioDIMENSIONAL breast implants, Styles KML, KMM, KLL, KLM Product Usage: Breast augmentation and Breast reconstruction; All Lots: Note:This product was not distributed within the US
Z-2464-2019	RITZ PRINCESS, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast Implant, Styles RML, RMM, RFL, RFM Product Usage: Breast augmentation and Breast reconstruction; All Lots: Note:This product was not distributed within the US
Z-2465-2019	Natrelle 150 Full Height and Short Height Implants, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast Implant, Styles 150 FH and 150 SH. Product Usage: Breast augmentation and Breast reconstruction; All Lots: Note:This product was not distributed within the US

Based on the official FDA remedy

What to do — step by step

Check Implant Style
Identify your implant's style number (e.g., 163-360CC, 168-120) to confirm if it's recalled.
Contact Your Surgeon
Reach out to your surgeon or implant specialist to discuss potential removal or monitoring options.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 49 states.

FDA distribution: “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,…” 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, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 56 days after the firm started it.

Jul 24, 2019Firm started the recall
Sep 11, 2019FDA classified it Class I
Sep 18, 2019Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to remove my implant?

The recall does not require immediate removal; consult your surgeon to determine if monitoring or removal is needed.

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Link to this recall

<a href="https://govinfonow.com/recall/67340-allergan-natrelle-breast-implants-recall-risk-of-bia-alcl">Allergan Natrelle Breast Implants Recall: Risk of BIA-ALCL (GovInfoNow)</a>

Where this comes from

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-2451-2019 (July 24, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2451-2019 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.