Allergan Sales, LLC: Medical Device Recall in 2024 - (Recall #: Z-1694-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only,

Product Classification:

Class II

Date Initiated: March 14, 2024

Date Posted: May 8, 2024

Recall Number: Z-1694-2024

Event ID: 94287

Reason for Recall:

Their is a potential that breast implants lack the lubricious coating that allows them to slide through the funnels during the implantation procedure.

Status: Ongoing

Product Quantity: 10837

Code Information:

UDI: 10888628043725 / Lot #: 23B35C, 23B41C, 23B42C, 23C05C, 23C06C, 23D01C, 24C12C

Distribution Pattern:

US Nationwide distribution including in the states of 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, VT, WA, WI, WV, WY.

Voluntary or Mandated:

Voluntary: Firm initiated