Keller Funnel 2 (Allergan) – Implant Coating Issue (2024)
Breast implant funnels may potentially lack proper lubricious coating for insertion.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only,
Brand
Allergan Sales, LLC
Lot Codes / Batch Numbers
UDI: 10888628043725 / Lot #: 23B35C, 23B41C, 23B42C, 23C05C, 23C06C, 23D01C, 24C12C
Products Sold
UDI: 10888628043725 / Lot #: 23B35C, 23B41C, 23B42C, 23C05C, 23C06C, 23D01C, 24C12C
Allergan Sales, LLC is recalling Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only, due to Their is a potential that breast implants lack the lubricious coating that allows them to slide through the funnels during the implantation procedure. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Their is a potential that breast implants lack the lubricious coating that allows them to slide through the funnels during the implantation procedure.
Recommended Action
Per FDA guidance
Between the dates of March 28, 2024 - April 1, 2024, Allergan Aesthetics (Allergan Sales LLC) issued a "Urgent Medical Device Recall" notification to affected consignees via FedEx. Allergan asked consignees to take the following actions: 1. If you have the affected product, discontinue further use and quarantine products prior to return. 2. Conduct a physical count of the affected product in your possession and record the count on the enclosed Business Response Form. 3. Send the Business Response Form to Qualanex LLC, AbbVie s third-party recall processor, via email within five (5) business days of receipt. To ensure we are able to account for all recalled product, it is imperative that you return the form. Please return the Business Response Form even if you have no recalled product to return. 4. Upon receipt of your Business Response Form, Qualanex LLC will issue a Return Authorization Form. When returning the recalled products, include the Return Authorization form and attach the prepaid Authorized Return shipping label to the outside of the return carton. Return the recalled product to: Qualanex, LLC 1410 Harris Rd. Libertyville, IL 60048 5. Please do not return any products that are not the subject of this recall. On 7/15/2025, updated recall notices were emailed to customers informing them of an additional impacted lot.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026