FDA Device recall Z-0799-2025
Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model Number: Q604237
- FDA Device
- Class II
- ongoing
- Published 2025-01-08
On 2025-01-08 the FDA classified a Class II recall of Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model Number: Q604237 by Carwild, citing potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0799-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-10-22 |
| Published | 2025-01-08 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Carwild |
| Distribution | AL, FL, IL, PA, SC |
Product
Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model Number: Q604237
Reason
Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product.
Identifiers
| code_info | LOT NUMBER: 24G1739 |
|---|
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-0799-2025%22
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