Z-1694-2024 Class II Ongoing
FDA device recall Z-1694-2024 was initiated by Allergan Sales, LLC on Mar 14, 2024 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 10837.
Recall details
- Product Type
- Devices
- Report Date
- May 8, 2024
- Initiation Date
- Mar 14, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10837
Product description
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 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.
Code information
UDI: 10888628043725 / Lot #: 23B35C, 23B41C, 23B42C, 23C05C, 23C06C, 23D01C, 24C12C
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1694-2024
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026