FDA Device recall Z-0800-2025
Ivalon Anatomical Nasal Packing with Airway Tube and String, 8.0 cm x 1.5cmx 3.0 cm- Intended To Be Used During Ophthalmic Surgical Procedu…
- FDA Device
- Class II
- ongoing
- Published 2025-01-08
On 2025-01-08 the FDA classified a Class II recall of Ivalon Anatomical Nasal Packing with Airway Tube and String, 8.0 cm x 1.5cmx 3.0 cm- Intended To Be Used During Ophthalmic Surgical Procedu… 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-0800-2025 |
| 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 Anatomical Nasal Packing with Airway Tube and String, 8.0 cm x 1.5cmx 3.0 cm- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model Number: Q770410
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: 24F1638 |
|---|
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-0800-2025%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.