RecallRadar

FDA Device recall Z-0571-2023

GEO-MED OPTHALMOLOGY CSTM PCK, REF 89-6387.08

On 2022-12-21 the FDA classified a Class II recall of GEO-MED OPTHALMOLOGY CSTM PCK, REF 89-6387.08 by Deroyal Industries, citing deRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0571-2023
ClassificationClass II
Statusongoing
Initiated2022-11-03
Published2022-12-21
Last updated2026-09-13 11:56 UTC
CompanyDeroyal Industries
DistributionAL, AZ, CT, FL, GA, IL, IN, KS, LA, MA, MI, MN, MO, MS, NC, NJ, NY, OH, PA, TN, TX, VA, WI

Product

GEO-MED OPTHALMOLOGY CSTM PCK, REF 89-6387.08

Reason

DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

Identifiers

code_infoLot Numbers: Lot 56065591 exp 8/1/1024; Lot 56618230 exp 9/1/2024

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0571-2023%22

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