Z-1694-2024Class II

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

Name: Z-1694-2024 Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only
Creator: Allergan Sales, LLC
Published: 2024-03-14
License: https://open.fda.gov/license/

Allergan / initiated 2024-03-14 / Open, Classified / root cause: manufacturing process

FDA source

Allergan Sales, LLC began a recall of Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only on 2024-03-14. FDA classified it as Class II and gives the reason as "Their is a potential that breast implants lack the lubricious coating that allows them to slide through the funnels during the implantation procedure". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1694-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-03-14
Posted: 2024-04-29
Recalling firm: Allergan
Product: Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only,
Product code: KDD Kit, Surgical Instrument, Disposable
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.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: 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.
Quantity in commerce: 10837
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.
Product codes and lots: UDI: 10888628043725 / Lot #: 23B35C, 23B41C, 23B42C, 23C05C, 23C06C, 23D01C, 24C12C

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1694-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1694-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-08	2024-04-29

Product code KDD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)