FDA Device recall Z-0307-2026
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-0307-2026 |
| 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' 8065000252 UNITY 27 GA CHANDELIER 8065000253 UNITY 27+DS WIDE ANGLE LIGHT PROBE 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: 8065000252 UDI-DI code: 00380650002525 Lot/Batch Numbers: 17CMKR 17D417 Catalog Number: 8065000253 UDI…Catalog Number: 8065000252 UDI-DI code: 00380650002525 Lot/Batch Numbers: 17CMKR 17D417 Catalog Number: 8065000253 UDI-DI code: 00380650002532 Lot/Batch Number: 17CDMX |
|---|
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-0307-2026%22
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