Recall Record

Wheat Ridge, CO, United States

PReye LLC recalls

1 recall recorded since 2018, most recently on 18 May 2026. 1 is listed as ongoing. Status and classification are as published by the FDA.

Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0

Ongoing Class II Drugs

Recall started
18 May 2026
Reason
Lack of Assurance of Sterility
Distribution
CO
Initiated
Voluntary: Firm initiated
Recall number
D-0621-2026

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.