Allergan PLC: Medical Device Recall in 2019 - (Recall #: Z-2460-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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

Product Classification:

Class I

Date Initiated: July 24, 2019

Date Posted: September 18, 2019

Recall Number: Z-2460-2019

Event ID: 83500

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.

Status: Ongoing

Product Quantity: 4,026,287 Breast Implants and Tissue Expanders Combined in total

Code Information:

All Lots: Note:This product was not distributed within the US

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated