Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During… — Class II medical device recall Z-0799-2025
Ongoing recall by Carwild Corporation, reported 2025-01-08, distributed in AL, FL, IL, PA, SC. Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the lif
| Recall number | Z-0799-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Carwild Corporation, New London, CT, United States |
| Recall initiated | 2024-10-22 |
| Classified | 2025-01-02 |
| Reported by FDA | 2025-01-08 |
| Distributed | AL, FL, IL, PA, SC |
| Countries outside the US | NL |
| Quantity | 300 units |
| Reason classes | sterility, specification failure, packaging |
| Lot numbers | 24G1739 |
| Model numbers | Q604237 |
Product
Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model Number: Q604237
Reason for recall
Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0799-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.