# FDA recall Z-1694-2024

> **Allergan Sales, LLC** · Class II · device recall initiated 2024-03-14.

## Product

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

## 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.

## Distribution

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.

## Key facts

- **Recall number:** Z-1694-2024
- **Recalling firm:** Allergan Sales, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-03-14
- **Report date:** 2024-05-08

- **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-1694-2024

## Citation

> AI Analytics. FDA recall Z-1694-2024. Retrieved 2026-07-17 from https://api.ai-analytics.org/recall/Z-1694-2024. Source: US FDA. Licensed CC0.

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