# FDA recall Z-2452-2019

> **Allergan PLC** · Class I · device recall initiated 2019-07-24.

## Product

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-4

## 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.

## 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.

## Key facts

- **Recall number:** Z-2452-2019
- **Recalling firm:** Allergan PLC
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-07-24
- **Report date:** 2019-09-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irvine, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2452-2019

## Citation

> AI Analytics. FDA recall Z-2452-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2452-2019. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*