NATRELLE Resterilizable Sizers for the styles and sizes: Style 15, Style 20, Inspira X (responsive gel),…
Medical device recall Z-0702-2020. Published in FDA’s Enforcement Report on Dec 25, 2019.
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 Dec 25, 2019. Copied from openFDA on Oct 20, 2026.
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 III, the least serious of FDA’s three classes.
“Products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing laws. Examples include: a minor container defect and lack of English labeling in a retail food.”
openFDA, in plain words, its enforcement report fields.
“Class III is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.”
FDA’s rule, 21 CFR 7.3(m)(3), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-1 configured scanners. These 2D barcodes contain a group separators between fixed-length element string in the UDI data chain of the 2D barcode, which is not formatted to the GS1 standard.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
NATRELLE Resterilizable Sizers for the styles and sizes: Style 15, Style 20, Inspira X (responsive gel), Inspira F (responsive gel), Inspira LP (responsive gel), Inspira M (responsive gel), Inspira L (responsive gel), Inspira ST L (Soft Touch gel), Inspira ST LP (Soft Touch Gel), Inspira ST M (Soft Touch Gel), Inspira ST F (Soft Touch Gel), Inspira ST X (Soft Touch Gel) Style 10/UDI: NATRELLE Sty 10-360 Rstrl Sizer Gel Mod 10888628005587 NATRELLE Sty 10-390 Rstrl Sizer Gel Mod 10888628005594 NATRELLE Sty 10-420 Rstrl Sizer Gel Mod 10888628005600 NATRELLE Sty 10-450 Rstrl Sizer Gel Mod 10888628005617 NATRELLE Sty 10-480 Rstrl Sizer Gel Mod 10888628005624 NATRELLE Sty 10-510 Rstrl Sizer Gel Mod 10888628005631 NATRELLE Sty 10-700 Rstrl Sizer Gel Mod 10888628005679 NATRELLE Sty 10-750 Rstrl Sizer Gel Mod 10888628005686 NATRELLE Sty 10-800 Rstrl Sizer Gel Mod 10888628005693 Style 15/UDI: NATRELLE Sty 15-304 Rstrl Sizer Gel Mid 10888628005778 NATRELLE Sty 15-339 Rstrl Sizer Gel Mid 10888628005785 NATRELLE Sty 15-371 Rstrl Sizer Gel Mid 10888628005792 NATRELLE Sty 15-397 Rstrl Sizer Gel Mid 10888628005808 NATRELLE Sty 15-421 Rstrl Sizer Gel Mid 10888628005815 NATRELLE Sty 15-457 Rstrl Sizer Gel Mid 10888628005822 NATRELLE Sty 15-492 Rstrl Sizer Gel Mid 10888628005839 NATRELLE Sty 15-533 Rstrl Sizer Gel Mid 10888628005846 NATRELLE Sty 15-575 Rstrl Sizer Gel Mid 10888628005853 NATRELLE Sty 15-616 Rstrl Sizer Gel Mid 10888628005860 Style 20/UDI: NATRELLE Sty 20-350 Rstrl Sizer Gel High 10888628006003 NATRELLE Sty 20-700 Rstrl Sizer Gel High 10888628006102 NATRELLE Sty 20-750 Rstrl Sizer Gel High 10888628006119 Inspira X (responsive Gel)/UDI: Natrelle Inspira X-Full 205cc Sizer (US) 10888628009431 Natrelle Inspira X-Full 225cc Sizer (US) 10888628009448 Natrelle Inspira X-Full 255cc Sizer (US) 10888628009455 Natrelle Inspira X-Full 285cc Sizer (US) 10888628009462 Natrelle Inspira X-Full 310cc Sizer (US) 10888628009479 Natrelle Inspira X-Full 340cc Sizer (US) 10888628009486 Natrelle Inspira X-Full 375cc Sizer (US) 10888628009493 Natrelle Inspira X-Full 400cc Sizer (US) 10888628009509 Natrelle Inspira X-Full 420cc Sizer (US) 10888628009516 Natrelle Inspira X-Full 445cc Sizer (US) 10888628009523 Natrelle Inspira X-Full 470cc Sizer (US) 10888628009530 Natrelle Inspira X-Full 495cc Sizer (US) 10888628009547 Natrelle Inspira X-Full 525cc Sizer (US) 10888628009554 Natrelle Inspira X-Full 545cc Sizer (US) 10888628009561 Natrelle Inspira X-Full 560cc Sizer (US) 10888628009578 Natrelle Inspira X-Full 580cc Sizer (US) 10888628009585 Natrelle Inspira X-Full 615cc Sizer (US) 10888628009592 Natrelle Inspira X-Full 650cc Sizer (US) 10888628009608 Natrelle Inspira X-Full 700cc Sizer (US) 10888628009615 Natrelle Inspira X-Full 750cc Sizer (US) 10888628009622 Natrelle Inspira X-Full 800cc Sizer (US) 10888628009639 Inspira F (responsive Gel)/UDI: MSZ-F180 Natrelle Inspira FullProf 180cc Sizer US 10888628009226 MSZ-F200 Natrelle Inspira FullProf 200cc Sizer US 10888628009233 MSZ-F220 Natrelle Inspira FullProf 220cc Sizer US 10888628009240 MSZ-F240 Natrelle Inspira FullProf 240cc Sizer US 10888628009257 MSZ-F265 Natrelle Inspira FullProf 265cc Sizer US 10888628009264 MSZ-F295 Natrelle Inspira FullProf 295cc Sizer US 10888628009271 MSZ-F325 Natrelle Inspira FullProf 325cc Sizer US 10888628009288 MSZ-F335 Natrelle Inspira FullProf 335cc Sizer US 10888628009295 MSZ-F345 Natrelle Inspira FullProf 345cc Sizer US 10888628009301 MSZ-F365 Natrelle Inspira FullProf 365cc Sizer US 10888628009318 MSZ-F385 Natrelle Inspira FullProf 385cc Sizer US 10888628009325 MSZ-F415 Natrelle Inspira FullProf 415cc Sizer US 10888628009332 MSZ-F450 Natrelle Inspira FullProf 450cc Sizer US 10888628009349 MSZ-F485 Natrelle Inspira FullProf 485cc Sizer US 10888628009356 MSZ-F520 Natrelle Inspira FullProf 520cc Sizer US 10888628009363 MSZ-F560 Natrelle Inspira FullProf 560cc Sizer US 10888628009370 MSZ-F605 Natrelle
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
MFG BATCHES: 2805096 2836786 2884422 2889999 2871740 2878486 2797264 2884426 3036126 3059070 3076451 3124452 3131479 3139882 3154328 3157493 3173220 3176664 3213097 3228743 2776706 2884427 2909055 2921210 3008017 3022733 3035530 3059463…
Every code shown here, 1,997 characters
MFG BATCHES: 2805096 2836786 2884422 2889999 2871740 2878486 2797264 2884426 3036126 3059070 3076451 3124452 3131479 3139882 3154328 3157493 3173220 3176664 3213097 3228743 2776706 2884427 2909055 2921210 3008017 3022733 3035530 3059463 3081093 3096446 3124773 3127774 3142976 3154566 3157086 3157779 3160817 3164079 3167339 3173664 3176918 3182507 3203867 3208283 3211090 3226125 2830860 2868178 2884428 2917776 2958518 2961802 3016093 3019001 3036261 3059268 3076606 3091713 3094037 3124627 3127656 3142812 3148324 3160679 3167175 3189825 3192733 3195360 3210981 3222913 3225690 3228367 2776708 2836794 2884429 2889922 2946579 2954640 2969639 2984574 2996667 3022702 3033348 3036318 3048122 3054598 3059270 3072727 3086874 3094041 3111501 3122044 3124633 3127660 3148328 3157024 3160683 3182357 3185283 3187738 3192736 3194955 3195363 3201094 3210983 3213144 3218861 3220208 3222917 2857336 2861149 2885103 2889923 2930931 2938820 2942044 2947325 2961631 2978758 3033774 3039663 3048103 3059258 3061979 3076599 3086861 3089420 3094030 3096326 3109045 3114260 3122038 3124620 3142805 3150489 3163894 3167170 3170299 3176782 3182348 3189822 3195356 3194950 3201091 3203719 3220198 3222907 3225687 2776710 2780920 2868180 2885104 2920849 2949477 2966841 2978889 2993586 3003249 3025633 3036756 3052473 3059075 3068639 3076456 3093894 3114095 3124453 3127551 3139626 3145481 3148173 3156943 3156819 3157496 3166974 3173225 3176668 3179679 3182211 3187690 3189712 3189474 3208036 3210856 3210531 3210532 2776711 2857338 2868182 2868181 2881296 2880809 2884433 2884432 2908823 2909354 2911816 2964385 2973964 3003294 3016089 3033302 3036337 3047857 3058980 3061727 3072625 3076364 3086598 3093556 3098673 3108882 3111280 3114013 3127484 3131437 3136877 3139820 3148089 3154250 3157421 3160491 3163650 3173123 3176622 3182142 3185096 3189657 3192583 3210808 3213057 3218674 3220001 3222732 2780921 2783860 2790896 2857339 2864408 2868183 2868184 2880812 2881300 2884434 2885106 2895628 2895862 2967070…
FDA’s list runs to 244,285 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.
US:AL, AR,AZ,CA,CO,DC,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,PR,RI,SC,SD,TN,TX,UT,VA,WA,WI,WY
The states and territories these words name
47 states and territories.
Every one of them
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- District of Columbia
- 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
- Washington
- Wisconsin
- Wyoming
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, 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 Nov 6, 2019.
- FDA classified it on Dec 18, 2019.
- FDA’s Enforcement Report published it on Dec 25, 2019.
- FDA terminated it on Jul 9, 2021.
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: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
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 244,285 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
-
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.