RegWardenFDA facility compliance records
Recall

Class II — Carwild Corporation

Recalling firmCARWILD CORPORATION
Registered facilityCARWILD CORP. (the firm's only registered facility)
ClassificationClass II
StatusOngoing
ReasonPotential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product.
ProductIvalon Eye Wick 20cm- Intended to be used for the removal and collection of fluids from the Opthalmic surgical site. Model Number: Q604206
Quantity120 units
DistributionIL, FL, SC. PA, AL Foreign: Netherlands
Initiated2024-10-22
Classified2025-01-02
Recall numberZ-0798-2025
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Carwild Corporation (Z-0798-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95909/

Not open yet

Alerts for CARWILD CORPORATION

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.