RecallRadar

FDA Device recall Z-2398-2019

EyeBOX Model OCL 02

On 2019-09-04 the FDA classified a Class II recall of EyeBOX Model OCL 02 by Oculogica, citing A review of the user manual revealed that two precaution statements were missing.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2398-2019
ClassificationClass II
Statusterminated
Initiated2019-04-16
Published2019-09-04
Last updated2026-09-13 11:55 UTC
CompanyOculogica
DistributionMD, NY

Product

EyeBOX Model OCL 02

Reason

A review of the user manual revealed that two precaution statements were missing.

Identifiers

code_infoSerial Numbers TT003, TT004, TT005

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2398-2019%22

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