Recall Record

New York, NY, United States

OCULOGICA recalls

1 recall recorded since 2018, most recently on 16 April 2019. None are listed as ongoing. Status and classification are as published by the FDA.

Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0

Terminated Class II Medical devices

Recall started
16 April 2019
Terminated
10 April 2020
Reason
A review of the user manual revealed that two precaution statements were missing.
Distribution
The products were distributed to the following US states: MD and NY
Initiated
Voluntary: Firm initiated
Recall number
Z-2398-2019

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.