FDA Device recall Z-1694-2024
Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only
- FDA Device
- Class II
- ongoing
- Published 2024-05-08
On 2024-05-08 the FDA classified a Class II recall of Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only by Allergan Sales, citing their is a potential that breast implants lack the lubricious coating that allows them to slide through the funnels during the implantation procedure.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1694-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-03-14 |
| Published | 2024-05-08 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Allergan Sales |
| Distribution | US |
Product
Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only,
Reason
Their is a potential that breast implants lack the lubricious coating that allows them to slide through the funnels during the implantation procedure.
Identifiers
| code_info | UDI: 10888628043725 / Lot #: 23B35C, 23B41C, 23B42C, 23C05C, 23C06C, 23D01C, 24C12C |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1694-2024%22
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