Allergan Sales, LLC: Keller Funnel 2 Recalled for Potential Lack of Lubricious Coating

Agency Publication Date: April 29, 2024

Summary

Allergan Sales, LLC has recalled 10,837 units of the Keller Funnel 2, a surgical device used during breast implant procedures. The recall was initiated because some of these funnels may lack the necessary lubricious coating that allows breast implants to slide through the device smoothly. This manufacturing defect can lead to difficulty during surgery and potential complications for the patient. Consumers should contact their healthcare provider or the manufacturer to confirm if their device is part of the affected batches.

Risk

If the funnel lacks its lubricious coating, the breast implant may not slide through the device correctly during implantation. This friction can result in surgical delays, damage to the implant, or the need for additional surgical maneuvers, which increases the risk of patient injury or infection.

What You Should Do

Identify if you have the affected Keller Funnel 2 (REF: HA-001) by checking the lot number on the sterile packaging or your medical records. The affected lot numbers are 23B35C, 23B41C, 23B42C, 23C05C, 23C06C, 23D01C, and 24C12C.
Verify the UDI (Unique Device Identifier) number 10888628043725 printed on the product label to ensure it matches the recalled units.
Immediately stop using any units from the affected lots and set them aside to ensure they are not used in future surgical procedures.
Contact your healthcare provider or Allergan Sales, LLC directly at their Irvine, California office to receive further instructions on how to return or handle the affected products and to discuss potential refunds or replacements.
For additional information or to report any issues, contact the FDA's medical device recall line at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer Notification and Device Instruction

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Keller Funnel 2, REF: HA-001, STERILEEO

Model / REF:

HA-001

Lot Numbers:

23B35C

23B41C

23B42C

23C05C

23C06C

23D01C

24C12C

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94287

Status: Active

Manufacturer: Allergan Sales, LLC

Sold By: Authorized medical distributors; Healthcare facilities

Manufactured In: United States

Units Affected: 10837

Distributed To: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia, Wyoming

Agency Last Updated: July 23, 2025

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify if you have the affected Keller Funnel 2 (REF: HA-001) by checking the lot number on the sterile packaging or your medical records. The affected lot numbers are 23B35C, 23B41C, 23B42C, 23C05C, 23C06C, 23D01C, and 24C12C.

Verify the UDI (Unique Device Identifier) number 10888628043725 printed on the product label to ensure it matches the recalled units.

Immediately stop using any units from the affected lots and set them aside to ensure they are not used in future surgical procedures.

Contact your healthcare provider or Allergan Sales, LLC directly at their Irvine, California office to receive further instructions on how to return or handle the affected products and to discuss potential refunds or replacements.

For additional information or to report any issues, contact the FDA's medical device recall line at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.