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.
Other recalls by Allergan Sales
- Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5% 5 mL bottles, Rx only, Allergan, Inc
FDA Drug · Class II · 2019-04-03 · Allergan Sales - Lumigan (bimatoprost ophthalmic solution) 0.01%, 2.5 mL bottle, Rx only, Allergan, Irvine, CA 92612
FDA Drug · Class III · 2017-11-22 · Allergan Sales - Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%, Rx only, packaged in a) 2.5 mL NDC# 0023-9211-03
FDA Drug · Class III · 2017-11-22 · Allergan Sales - Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2% sterile, 3.5 g tube, RX only, Manufactured by…
FDA Drug · Class II · 2017-07-05 · Allergan Sales - Lumigan (bimatoprost ophthalmic solution) 0.01%, 7.5 mL bottle, Rx only, Allergan Irvine, CA 92612, NDC 0023-3205-08
FDA Drug · Class III · 2017-04-19 · Allergan Sales
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1694-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.