Natrelle Inspira, Silicone-Filled Breast Implants, Sterile, for the following style numbers: Style TRL:…
Medical device recall Z-2453-2019. Published in FDA’s Enforcement Report on Sep 18, 2019.
- FDA Class I
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Sep 18, 2019. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 52 states named
- 4,026,287 Breast Implants and Tissue Expanders Combined in total how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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
4,026,287 Breast Implants and Tissue Expanders Combined in total, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,996 characters
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,…
FDA’s list runs to 7,424 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
The states and territories these words name
52 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Puerto Rico
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- US Virgin Islands
- Washington
- Wisconsin
- West Virginia
- Wyoming
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jul 24, 2019.
- FDA classified it on Sep 11, 2019.
- FDA’s Enforcement Report published it on Sep 18, 2019.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Allergan PLC, of Irvine, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Press Release.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 7,424 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.