CLASS II ONGOING Device recall · Reported 21 Dec 2022 · FDA Enforcement Report

Geo-med Opthalmology Cstm Pck recalled by DeRoyal Industries

DeRoyal Industries is recalling Geo-med Opthalmology Cstm Pck, distributed in 23 states. The recall was initiated on 3 Nov 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers: Lot 56065591 exp 8/1/1024; Lot 56618230 exp 9/1/2024
Quantity recalled90 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-0571-2023
FDA event ID
91134
Recalling firm
DeRoyal Industries, Powell, TN
Classification
Class II
Status
Ongoing
Recall initiated
3 Nov 2022
FDA classified
15 Dec 2022
Reported
21 Dec 2022
Type
Voluntary: Firm initiated
Customers notified by
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category
Other Reasons

Timeline

3 Nov 2022Recall initiated by company
15 Dec 2022Classified by FDA+42 days
21 Dec 2022Published in enforcement report+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

GEO-MED OPTHALMOLOGY CSTM PCK, REF 89-6387.08

Where it was distributed

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

AlabamaArizonaConnecticutFloridaGeorgiaIllinoisIndianaKansasLouisianaMassachusettsMichiganMinnesotaMissouriMississippiNorth CarolinaNew JerseyNew YorkOhioPennsylvaniaTennessee

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

100 other products · FDA event 91134

This product is part of a recall event; the main page for the event is DeRoyal Myelogram Pack recalled by DeRoyal Industries.

ReportedClassRecallCompanyReasonWhere
CLASS IIDeRoyal Myelogram Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Lumbar/Cervical Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal VIT RD PACK 86ST recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Foot Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Pain Tray recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Shoulder KIT recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Cannulted Hip Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Trans Canal Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Facial Pack Pgybk recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Cataract Pack Csm recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Kit Heart B Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Tracecart Posteror Lumbar Fusion Tracecart recalledDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Shoulder Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Minor Oral / ENT Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Kit Extremity Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Shoulder Arthoscopy Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Retinal Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIGeo-med Plastic Hand Pack Rf recalled by DeRoyal IndustriesDeRoyal IndustriesForeign Material23 states
CLASS IIGeo-med Opthalmology Cstm Pck recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Laparoscopic Robotic Tray recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Cnrv Peripheral Vas Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIGeo-med Plastic Hand Pack Rf recalled by DeRoyal IndustriesDeRoyal IndustriesForeign Material23 states
CLASS IIDeRoyal Tracecart Posteror Lami Microdisc Tracecart recalledDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Hand Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIGeo-med Total Knee Pack A & B Pgyk recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Myelogram Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Pedi Ortho Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Basic Neuro Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Total Knee Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Tracecart Shoulder Arthroscopy Tracecart recalledDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Major Oral Pack RF recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIGeo-med Local Anesthesia Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal EYE TRAY recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Spinal Fusion Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Custom Neuro Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Emergent Trauma Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Laminectomy Spinal Fusion Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Cataract Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Crani Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Lapinectomy Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Total Hip Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Total Hip Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Pacemaker ICD Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Spine Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal KIT Total HIP recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Crani Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Lumbar Disc Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Spine Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Universal Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Posterior Lami Microdisc Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Cataract Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Posterior Lumbar Fusion Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Biopsy Packpack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Lumbar Disc Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Emergent Trauma Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Port Pack Pgybk recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIGeo-med Knee Arthroscopy Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Lumbar Fusion Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Lami/Crani Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Spinal Fusion Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Heart Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Crani Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Basic Neuro Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Shoulder Arthoscopy Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIGeo-med Upper Extermity Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIGeo-med Biopsy Tray recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Cataract Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Anterior Approach Total Hip A&b Pgybk recalledDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Total Knee Pack A & B Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Open Shoulder Procedure Pack RF recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal GU PACK recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Biopsy Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Endovascular Tracepack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Cataract Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Cataract Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Cnrv Spinal Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Heart Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Basic Neuro Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Acdf Pack Pgybk A Pack / B Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIGeo-med Cataract Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Shoulder Arthoscopy Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Tlif Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Acdf Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Ortho Spine Back Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Breast Augmentation Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Podiatry Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Laminectomy Spinal Fusion Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Foot Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Neuro Spine Back Pack Pgybk recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Laminectomy Spinal Fusion Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Neuro Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Hand Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Pain Tray recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal PICC Line Tray Pgybk recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIGeo-med Total Knee Pack A & B recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Cardiac Linen Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Shoulder Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Cannulted Hip Pack Csm recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Biopsy Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states
CLASS IIDeRoyal Foot Pack recalled by DeRoyal IndustriesDeRoyal IndustriesOther23 states

More recalls from DeRoyal Industries

All 226
ReportedClassRecallCompanyReasonWhere
DeviceCLASS IIDeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access recalledDeRoyal IndustriesSterilityNationwide
DeviceCLASS IIDeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF recalledDeRoyal IndustriesForeign Material5 states
DeviceCLASS IIDeRoyal AMG Suction Connector Tubing recalled by DeRoyal IndustriesDeRoyal IndustriesPackaging Defects21 states
DeviceCLASS IIDeRoyal C-section Tracepack recalled by DeRoyal IndustriesDeRoyal IndustriesOtherNationwide
DeviceCLASS IIDeRoyal Children's General Tracepack recalled by DeRoyal IndustriesDeRoyal IndustriesOtherNationwide

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