Drug recall
Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical…
FDA recall event 97415 · Class II · Alcon Research LLC
Key facts
| Event ID | 97415 |
|---|---|
| Recall numbers | Z-0304-2026, Z-0305-2026, Z-0306-2026, Z-0307-2026, Z-0308-2026 |
| Recalling firm | Alcon Research LLC |
| Product type | Devices |
| Products | 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' 8065000250…, 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…, 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' 8065000356…, 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…, 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' 8065750918… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Due to incomplete seals in the pouch which provide the sterile barrier. |
| Initiation date | Aug 5, 2025 |
| Report date | Nov 5, 2025 |
| City | Fort Worth |
| State | TX |
| Country | United States |
| FEI number | 1610287 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: