FDA Device recall Z-0306-2026
Brand Name: Alcon Laboratories, Inc
- FDA Device
- Class II
- ongoing
- Published 2025-11-05
On 2025-11-05 the FDA classified a Class II recall of Brand Name: Alcon Laboratories, Inc by Alcon Research, citing due to incomplete seals in the pouch which provide the sterile barrier.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0306-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-08-05 |
| Published | 2025-11-05 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Alcon Research |
| Distribution | US |
Product
Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000393 UNITY HP VISCOUS FLUID CONTROL VFC PACK Software Version: N/A Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console. Component: N/A
Reason
Due to incomplete seals in the pouch which provide the sterile barrier.
Identifiers
| code_info | Catalog Number: 8065000393 UDI-DI code: 00380650003935 Lot/Batch Number: 17CDKX |
|---|
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 Alcon Research
- GenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl oz), Distributed by: Alcon Laboratories, Inc., Fort Worth, Texas 76134, USA, NDC: 0…
FDA Drug · Class II · 2026-05-06 · Alcon Research - Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in France for: Alcon Laboratiroes, Inc., Fort Worth, TX 76134, USA…
FDA Drug · Class II · 2026-05-06 · Alcon Research - Brand Name: Alcon Laboratories, Inc
FDA Device · Class I · 2025-12-31 · Alcon Research - CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: 25+ TOTALPLUS CP PAK 20K CPM BWV .9 IU/ 8065000093
FDA Device · Class II · 2025-12-03 · Alcon Research - Brand Name: Alcon Laboratories, Inc
FDA Device · Class II · 2025-11-05 · Alcon Research
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0306-2026%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.