Carwild Corporation recalls Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgical Proced…

Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product.

Carwild Corp issued letter On Behalf Of First Aid Bandage Company (Fabco) Recall Notice Urgent via email 12/22/24. Letter states reason for recall, health risk and action to take; Cease Further Distribution Or Use Of Any Remaining Product Immediately . Distributors are responsible to notify all your customers who may have received this product. Please provide shipment history. Call for questions or additional information: Regulatory 1-860-442-4914 x111 Customer Service 1-860-442-4914 x110 .

• FDA enforcement recordOfficial FDA database entry for Z-0799-2025
• FDA 510(k) clearance · K971832The device's official FDA premarket clearance record
• FDA device classification · HOZOfficial FDA classification for this device type
• CFR regulation · 21 CFR 886.4790The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Carwild CorporationSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.