# FDA recall Z-2458-2019

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

## Product

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.

## 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-2458-2019
- **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-2458-2019

## Citation

> AI Analytics. FDA recall Z-2458-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2458-2019. Source: US FDA. Licensed CC0.

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