DeRoyal Industries Inc
Medical device manufacturer in Powell, TN.
92510(k) clearances
0PMA approvals
236recalls
Device types
- FMQ Restraint, Protective 15
- KKX Drape, Surgical, Antimicrobial 11
- FLL Continuous Measurement Thermometer 3
- KID Restraint, Wheelchair, Non-Protective 3
- FMT Warmer, Infant Radiant 3
- GEI Electrosurgical, Cutting & Coagulation &… 3
- BZT Stethoscope, Esophageal, With Electrical… 3
- GCJ Laparoscope, General & Plastic Surgery 3
- KGX Tape And Bandage, Adhesive 3
- MDM Instrument, Manual, Surgical, General Use 2
- HIF Insufflator, Laparoscopic 2
- EYC Catheter, Upper Urinary Tract 2
- DQO Catheter, Intravascular, Diagnostic 2
- OMP Negative Pressure Wound Therapy Powered… 2
- DXQ Blood Pressure Cuff 2
- HRS Plate, Fixation, Bone 2
- FRO Dressing, Wound, Drug 2
- MGO Closure, Wound, Adhesive 1
- GDT Staple, Removable (Skin) 1
- HNN Knife, Ophthalmic 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K250586 | Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam…OMP · Traditional | 11/21/2025SE |
| K230233 | Prospera Spectruum Negative Pressure Wound Therapy SystemOMP · Traditional | 04/18/2024SE |
| K200631 | DeRoyal Temperature Monitoring ProbeFLL · Traditional | 12/23/2020SE |
| K200757 | Foley Catheter with Temperature SensorEYC · Traditional | 10/15/2020SE |
| K200319 | HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface…FMT · Traditional | 04/02/2020SE |
| K193027 | Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal…BZT · Traditional | 04/02/2020SE |
| K191425 | Hydro-Temp Neonatal Skin Temperature Probe CoverFMT · Traditional | 01/21/2020SE |
| K173072 | Algidex Ag Silver Alginate Wound DressingFRO · Traditional | 04/04/2018SE |
| K171475 | DeRoyal Laprador Specimen Retrieval SystemGCJ · Traditional | 08/17/2017SE |
| K152978 | DeRoyal Angiography KitsDXT · Traditional | 03/25/2016SESK |
| K142962 | PROTOCOL Incision DressingFRO · Traditional | 07/23/2015SE |
| K131292 | Deroyal Spine Spacer SystemMAX · Traditional | 02/03/2014SE |
| K132199 | Deroyal Electrosurgical Pencil, Rocker Style Without Holster, Deroyal Electrosurgical…GEI · Traditional | 10/03/2013SE |
| K090975 | Deroyal Non-Locking Bone Fixation SystemHRS · Traditional | 04/12/2010SE |
| K092317 | Deroyal Non-Sterile Locking Compression Plate SystemHRS · Traditional | 11/02/2009SE |
| K023591 | Ultra High Pressure Injector LinesDQO · Traditional | 06/18/2003SE |
| K030365 | Deroyal Drapes, Sterile, Non-SterileKKX · Traditional | 04/29/2003SE |
| K030364 | Deroyal Gowns, Sterile, Non-SterileFYA · Traditional | 04/28/2003SE |
| K991525 | Deroyal Sterile Neonatal Blood Pressure CuffDXQ · Traditional | 07/20/1999SE |
| K983750 | Deroyal Industries, Inc Tracecart Sharps Collection ContainerFMI · Traditional | 11/30/1998SE |
| K982465 | Deroyal Industries, Inc. DefoggerOCT · Traditional | 08/11/1998SE |
| K974763 | Deroyal Industries Disposable Surgical Trocar/CannulaHET · Traditional | 07/10/1998SE |
| K980509 | Deroyal Industries, Inc. Infant Transport MattressIMD · Traditional | 02/26/1998SE |
| K972693 | Deroyal Industries, Inc. Surgical Eye SpearHOZ · Traditional | 09/30/1997SE |
| K970993 | Deroyal Industries, Inc. Disposable Bipolar Electrosurgical CableGEI · Traditional | 05/22/1997SE |
| K963466 | Pediatric Limb HolderFMQ · Traditional | 02/13/1997SE |
| K963479 | Wheelchair BeltKID · Traditional | 01/24/1997SE |
| K963480 | Multi-Purpose Utility Restraint/Body HolderKID · Traditional | 01/22/1997SE |
| K963476 | Disposable Limb HolderFMQ · Traditional | 01/22/1997SE |
| K963475 | Poncho Vest RestraintKID · Traditional | 01/22/1997SE |
| K963474 | Tuxedo Vest RestraintFMQ · Traditional | 01/22/1997SE |
| K963468 | Restrictive Limb HolderFMQ · Traditional | 01/22/1997SE |
| K963467 | Roll BeltsFMQ · Traditional | 01/03/1997SE |
| K963465 | Pelvic HolderFMQ · Traditional | 12/19/1996SE |
| K963478 | Sleeved/Sleeveless Vest RestraintFMQ · Traditional | 11/14/1996SE |
| K963473 | Reusable Limb HolderFMQ · Traditional | 11/14/1996SE |
| K963472 | Pediatric Vest RestraintFMQ · Traditional | 11/14/1996SE |
| K963471 | Super Security RestraintFMQ · Traditional | 11/14/1996SE |
| K963470 | Criss-Cross Vest RestraintFMQ · Traditional | 11/14/1996SE |
| K963469 | MittensFMQ · Traditional | 11/14/1996SE |
| K963477 | Pediatric MittensFMQ · Traditional | 11/12/1996SE |
| K963464 | Restraint NetFMQ · Traditional | 11/12/1996SE |
| K963463 | Strait JacketFMQ · Traditional | 10/16/1996SE |
| K961647 | Deroyal Industries, Inc. Electrosurgical Cautery PencilGEI · Traditional | 10/08/1996SE |
| K950565 | Deroyal Surgical Instrument DrapeKKX · Traditional | 12/13/1995SE |
| K953403 | Deroyal Industries, Inc. Polyderm & Polyderm Border Foam Wound DressingsKMF · Traditional | 10/06/1995SN |
| K952775 | Deroyal Wound Care Multidex Gel Wound DressingMGQ · Traditional | 10/06/1995SN |
| K953953 | Deroyal Industries, Inc. Pneumatic Tourniquet CuffKCY · Traditional | 09/29/1995SE |
| K953952 | Deroyal Industris, Inc. Blood Pressure CuffDXQ · Traditional | 09/28/1995SE |
| K951178 | Urological Catheter & AccessoriesFCM · Traditional | 04/21/1995SE |
| K945789 | Deroyal Disposable Insufflation Tubing FilterHIF · Traditional | 02/07/1995SE |
| K935985 | Deroyal Critical Care Disposable Waste StationDQO · Traditional | 12/21/1994SE |
| K944435 | Dosposable Enoscopic Hernia Surgical StaplerOCW · Traditional | 11/15/1994SE |
| K940169 | Debusk Temperature Systems Premier and Signature Series Multi-Purpose Esophageal…BZT · Traditional | 07/28/1994SE |
| K942879 | Deroyal Surgical's Endoscopic Specimen Retrieval PouchGCJ · Traditional | 07/19/1994SE |
| K941390 | Disposable Aspiration/Irrigation Trumpet Valve ProbeGCJ · Traditional | 06/09/1994SE |
| K925792 | Exac-Temp & Clini-Temp Tympanic & Myocardial ProbeFLL · Traditional | 04/08/1994SE |
| K934188 | Deroyal Surg Disp/Reusable Skin Stapler Handle/CartGAG · Traditional | 03/28/1994SE |
| K934131 | Deroyal Surgical Disposable Insufflation TubingHIF · Traditional | 03/07/1994SE |
| K925791 | Exac-Temp & Clini-Temp Probe W/Temperature SensorFLL · Traditional | 02/25/1994SE |
| K935725 | Episeal Adhesive Wound Closure StripsKGX · Traditional | 02/04/1994SE |
| K925006 | Hydro-Temp Nicu and Skin Surface Temperature SensoFMT · Traditional | 01/31/1994SE |
| K925789 | Debusk Temp. Syst. Esophageal StethoscopeBZT · Traditional | 07/13/1993SE |
| K925790 | Exac-Temp & Clini-Temp Foley Catheter'sEYC · Traditional | 05/17/1993SE |
| K923300 | Deroyal Eye DressingKGX · Traditional | 09/01/1992SE |
| K921350 | Qualtex Tube/Cord OrganizerKKX · Traditional | 08/04/1992SE |
| K920796 | Deroyal Transparent Film DressignMGP · Traditional | 07/23/1992SE |
| K921349 | Sterile,Disposable Eye DressingHMP · Traditional | 05/29/1992SE |
| K915182 | Deroyal Hydrogel DressingNAE · Traditional | 04/21/1992SE |
| K913486 | Qualtex Surgical Drape, ModificationKKX · Traditional | 02/05/1992SE |
| K914369 | Qualtex Magnetic Instrument DrapeKKX · Traditional | 12/02/1991SE |
| K912472 | Deroyal Wound DressingMGO · Traditional | 10/02/1991SE |
| K910657 | Qualtex Island DressingKGX · Traditional | 07/01/1991SE |
| K911369 | Qualtex Light Handle and Light Handle CoverMDM · Traditional | 05/13/1991SE |
| K911895 | Qualtex Suture BootiesMDM · Traditional | 05/08/1991SE |
| K911204 | Qualtex Skin Staple ExtractorGDT · Traditional | 05/08/1991SE |
| K910495 | Qualtex Surgical DrapeKKX · Traditional | 02/19/1991SE |
| K904960 | Qualtex Surgical DrapeKKX · Traditional | 12/13/1990SE |
| K903947 | Qualtex Needle CountersMMK · Traditional | 10/30/1990SE |
| K895427 | Mediseal Suction CanisterDWD · Traditional | 01/19/1990SE |
| K884790 | Qualtex Neurolok Surgical SpongeGDY · Traditional | 12/09/1988SE |
| K864388 | Modified Disposable Sterile Towel Used in SurgeryKKX · Traditional | 02/20/1987SE |
| K861969 | Sterile Towel W/Antimicrobial AgentKKX · Traditional | 06/04/1986SE |
| K861196 | Sterile Stockinette W/Antimicrobial AgentKKX · Traditional | 04/30/1986SE |
| K860326 | Tubular Ortho. Stockinette W/Antimicrobial AgentKKX · Traditional | 02/21/1986SE |
| K842647 | Cataract TrayHNN · Traditional | 05/09/1985SE |
| K842644 | Tpn/Hyperalimentation TrayFRG · Traditional | 11/08/1984SE |
| K842626 | Hip Prosthesis Pack · Traditional | 10/24/1984SE |
| K842627 | C-Section TrayKDD · Traditional | 09/26/1984SE |
| K842648 | General Surgery TrayLRO · Traditional | 09/20/1984SE |
| K842625 | Custom Neuro Tray · Traditional | 09/20/1984SE |
| K842645 | Cardiac Supply TrayDQY · Traditional | 08/27/1984SE |
Recalls (latest 200)
| Recall | Product | Initiated |
|---|---|---|
| Z-3256-2026 | REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 SeriesMyocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead… | 08/20/2026Open, Classified |
| Z-2305-2026 Class II | DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6"…Sterile wound dressing, lacks sterility assurance | 05/18/2026Open, Classified |
| Z-1291-2025 Class II | DeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF 71-C6100NS Tubing…Due to the inner diameter of the suction tubing connector being smaller than the suction canister lid port… | 01/31/2025Open, Classified |
| Z-1174-2025 Class II | DeRoyal AMG Suction Connector Tubing REF: 71-2083, 71-C506, 71-C510, 71-C512, 71-C520…The tubing may not ensure that the yankauer stays intact, and secure to the tubing / yankauer connection for… | 01/15/2025Open, Classified |
| Z-0309-2025 Class II | DeRoyal CHILDREN'S LAPTRACEPACK, 89-9362.06DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke… | 10/03/2024Open, Classified |
| Z-0308-2025 Class II | DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke… | 10/03/2024Open, Classified |
| Z-0307-2025 Class II | DeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-06DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke… | 10/03/2024Open, Classified |
| Z-0306-2025 Class II | DeRoyal C-SECTION TRACEPACK, REF 89-9338-06DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke… | 10/03/2024Open, Classified |
| Z-1382-2024 Class I | GeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECART, b)…DeRoyal manufactured and distributed Surgical Tracecarts that contain a Nurse Assist 16FR Silver Urine Meter… | 02/13/2024Open, Classified |
| Z-0622-2024 Class II | DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572Kit were manufactured and distributed with Edwards Life Sciences TruWave Disposable pressure transducers… | 11/22/2023Open, Classified |
| Z-0116-2024 Class II | DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kitDeRoyal is recalling certain lots of surgical procedure pack products that contain the B.Braun Medical… | 09/18/2023Open, Classified |
| Z-2090-2023 Class II | Custom medical procedure packs labeled as: a) CATH ANGIOGRAPHY DRAPE PACK, REF 89-7102…The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside. | 05/30/2023Open, Classified |
| Z-2089-2023 Class II | Custom medical procedure packs labeled as: a) PELVIC EXAM TRAY, REF 89-6219The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside. | 05/30/2023Open, Classified |
| Z-2088-2023 Class II | Custom medical procedure packs labeled as: a) STANDARD OB PACK ASCENSION WI, REF…The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside. | 05/30/2023Open, Classified |
| Z-2087-2023 Class II | Custom medical procedure packs labeled as: a) STURDI STRAINER TRAY STANDARD, REF '89-5014The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside. | 05/30/2023Open, Classified |
| Z-2086-2023 Class II | Custom medical procedure packs labeled as: a) OPEN HEART TRACECART, REF '53-1941; b)…The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside. | 05/30/2023Open, Classified |
| Z-1692-2023 Class II | Sterile custom surgical procedure packs (1) 89-10529.04, CNRV OR C-SECTION PACK, New…The custom procedure packs contain light handle covers that have been recalled by another firm. | 04/17/2023Open, Classified |
| Z-1691-2023 Class II | Sterile custom surgical procedure packs: (1) 89-10507.02, TOTAL KNEE PACK, Stonewall…The custom procedure packs contain light handle covers that have been recalled by another firm. | 04/17/2023Open, Classified |
| Z-1283-2023 Class II | DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000BThe reason for the voluntary recall is due to shrinkage of the canister lid. This shrinkage causes the lid… | 02/09/2023Open, Classified |
| Z-0927-2023 Class II | DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10DeRoyal is recalling certain lots of surgical procedure pack products that contain a Medtronic… | 12/12/2022Terminated |
| Z-0906-2023 Class II | DeRoyal Tonsillectomy Tray, REF 89-10698.01DeRoyal is recalling certain lots of surgical procedure pack products that contain a ConMed Foot Controlled… | 11/28/2022Terminated |
| Z-0715-2023 Class II | DeRoyal CATARACT PACK, REF 89-10086.05DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. | 11/03/2022Open, Classified |
| Z-0714-2023 Class II | DeRoyal CATARACT PACK, REF 89-10040.01XXX | 11/03/2022Open, Classified |
| Z-0713-2023 Class II | DeRoyal CATARACT PACK, REF 89-9241.04XXX | 11/03/2022Open, Classified |
| Z-0712-2023 Class II | DeRoyal CATARACT PACK, REF 89-9241.03XXX | 11/03/2022Open, Classified |
| Z-0711-2023 Class II | DeRoyal CATARACT PACK, REF 89-8859.08XXX | 11/03/2022Open, Classified |
| Z-0710-2023 Class II | DeRoyal CATARACT PACK, REF 89-8650.10XXX | 11/03/2022Open, Classified |
| Z-0709-2023 Class II | GEO-MED CATARACT PACK, REF 89-5790.08XXX | 11/03/2022Open, Classified |
| Z-0708-2023 Class II | DeRoyal TRACECART POSTEROR LAMI MICRODISC TRACECART, REF 53-1960.02XXX | 11/03/2022Open, Classified |
| Z-0707-2023 Class II | DeRoyal TRACECART POSTEROR LUMBAR FUSION TRACECART, REF 53-1961.02XXX | 11/03/2022Open, Classified |
| Z-0706-2023 Class II | DeRoyal TRACECART SHOULDER ARTHROSCOPY TRACECART, REF 53-1962.02XXX | 11/03/2022Open, Classified |
| Z-0705-2023 Class II | DeRoyal BIOPSY PACKPACK, REF 89-9756.05XXX | 11/03/2022Open, Classified |
| Z-0704-2023 Class II | DeRoyal TOTAL KNEE PACK A & B PACK, REF 89-6799.02XXX | 11/03/2022Open, Classified |
| Z-0703-2023 Class II | DeRoyal PACEMAKER ICD PACK, REF 89-10902.01XXX | 11/03/2022Open, Classified |
| Z-0702-2023 Class II | DeRoyal NEURO SPINE BACK PACK PGYBK, REF 89-10853.01XXX | 11/03/2022Open, Classified |
| Z-0701-2023 Class II | DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-10820.02XXX | 11/03/2022Open, Classified |
| Z-0700-2023 Class II | GEO-MED LOCAL ANESTHESIA PACK, REF 89-10800.01XXX | 11/03/2022Open, Classified |
| Z-0699-2023 Class II | DeRoyal LAMI/CRANI PACK, REF 89-10787.01XXX | 11/03/2022Open, Classified |
| Z-0698-2023 Class II | DeRoyal NEURO PACK, REF 89-10682.02XXX | 11/03/2022Open, Classified |
| Z-0697-2023 Class II | DeRoyal GU PACK, REF 89-10665.03XXX | 11/03/2022Open, Classified |
| Z-0696-2023 Class II | DeRoyal GU PACK, REF 89-10665.02XXX | 11/03/2022Open, Classified |
| Z-0695-2023 Class II | DeRoyal ANTERIOR APPROACH TOTAL HIP A&B PGYBK, REF 89-10612.01XXX | 11/03/2022Open, Classified |
| Z-0694-2023 Class II | DeRoyal LUMBAR DISC PACK, REF 89-10605.02XXX | 11/03/2022Open, Classified |
| Z-0693-2023 Class II | DeRoyal LUMBAR DISC PACK, REF 89-10590.02XXX | 11/03/2022Open, Classified |
| Z-0692-2023 Class II | DeRoyal CMC POSTERIOR SPINE PACK, REF 89-10570.01XXX | 11/03/2022Open, Classified |
| Z-0691-2023 Class II | DeRoyal CARDIAC LINEN PACK, REF 89-10543.02XXX | 11/03/2022Open, Classified |
| Z-0690-2023 Class II | DeRoyal CNRV SPINAL PACK, REF 89-10532.03XXX | 11/03/2022Open, Classified |
| Z-0689-2023 Class II | DeRoyal CNRV PERIPHERAL VAS PACK, REF 89-10530.03XXX | 11/03/2022Open, Classified |
| Z-0688-2023 Class II | DeRoyal PAIN TRAY, REF 89-10464.03XXX | 11/03/2022Open, Classified |
| Z-0687-2023 Class II | DeRoyal PAIN TRAY, REF 89-10464.02XXX | 11/03/2022Open, Classified |
| Z-0686-2023 Class II | DeRoyal HAND PACK, REF 89-10314.03XXX | 11/03/2022Open, Classified |
| Z-0685-2023 Class II | DeRoyal HAND PACK, REF 89-10314.02XXX | 11/03/2022Open, Classified |
| Z-0684-2023 Class II | DeRoyal CRANI PACK, REF 89-10242.04DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. | 11/03/2022Open, Classified |
| Z-0683-2023 Class II | DeRoyal CRANI PACK, REF 89-10242.02XXX | 11/03/2022Open, Classified |
| Z-0682-2023 Class II | DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-10240.03XXX | 11/03/2022Open, Classified |
| Z-0681-2023 Class II | DeRoyal PACEMAKER ICD PACK, REF 89-10216.06XXX | 11/03/2022Open, Classified |
| Z-0680-2023 Class II | DeRoyal PACEMAKER ICD PACK, REF 89-10216.03XXX | 11/03/2022Open, Classified |
| Z-0679-2023 Class II | DeRoyal LUMBAR FUSION PACK, REF 89-10211.05XXX | 11/03/2022Open, Classified |
| Z-0678-2023 Class II | DeRoyal LAMINECTOMY PACK, REF 89-10209.02XXX | 11/03/2022Open, Classified |
| Z-0677-2023 Class II | DeRoyal CRANI PACK, REF 89-10202.05XXX | 11/03/2022Open, Classified |
| Z-0676-2023 Class II | DeRoyal CRANI PACK, REF 89-10202.03XXX | 11/03/2022Open, Classified |
| Z-0675-2023 Class II | DeRoyal NEURO PACK, REF 89-10171.06XXX | 11/03/2022Open, Classified |
| Z-0674-2023 Class II | DeRoyal NEURO PACK, REF 89-10171.05XXX | 11/03/2022Open, Classified |
| Z-0673-2023 Class II | DeRoyal NEURO PACK, REF 89-10171.03XXX | 11/03/2022Open, Classified |
| Z-0672-2023 Class II | DeRoyal TOTAL SHOULDER PACK, REF 89-10151.05XXX | 11/03/2022Open, Classified |
| Z-0671-2023 Class II | DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-10061.02XXX | 11/03/2022Open, Classified |
| Z-0670-2023 Class II | DeRoyal POSTERIOR LUMBAR FUSION PACK, REF 89-10060.02XXX | 11/03/2022Open, Classified |
| Z-0669-2023 Class II | DeRoyal POSTERIOR LAMI MICRODISC PACK, REF 89-10059.02XXX | 11/03/2022Open, Classified |
| Z-0668-2023 Class II | DeRoyal FACIAL PACK PGYBK, REF 89-10007.03XXX | 11/03/2022Open, Classified |
| Z-0667-2023 Class II | DeRoyal ACDF PACK PGYBK A PACK / B PACK, REF 89-9997.06XXX | 11/03/2022Open, Classified |
| Z-0666-2023 Class II | DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-9946.04XXX | 11/03/2022Open, Classified |
| Z-0665-2023 Class II | DeRoyal BIOPSY PACK, REF 89-9739.06XXX | 11/03/2022Open, Classified |
| Z-0664-2023 Class II | DeRoyal BIOPSY PACK, REF 89-9739.05XXX | 11/03/2022Open, Classified |
| Z-0663-2023 Class II | DeRoyal BREAST AUGMENTATION PACK, REF 89-9618.05XXX | 11/03/2022Open, Classified |
| Z-0662-2023 Class II | DeRoyal BIOPSY PACK, REF 89-9614.07XXX | 11/03/2022Open, Classified |
| Z-0661-2023 Class II | DeRoyal UNIVERSAL PACK, REF 89-9558.03XXX | 11/03/2022Open, Classified |
| Z-0660-2023 Class II | DeRoyal ABDOMINOPLASTY W/LIPO PACK, REF 89-9557.03XXX | 11/03/2022Open, Classified |
| Z-0659-2023 Class II | DeRoyal LUMBAR/CERVICAL PACK, REF 89-9521.11XXX | 11/03/2022Open, Classified |
| Z-0658-2023 Class II | DeRoyal TOTAL HIP KIT, REF 89-9498.10XXX | 11/03/2022Open, Classified |
| Z-0657-2023 Class II | DeRoyal TOTAL HIP KIT, REF 89-9498.08XXX | 11/03/2022Open, Classified |
| Z-0656-2023 Class II | DeRoyal SHOULDER KIT, REF 89-9497.10XXX | 11/03/2022Open, Classified |
| Z-0655-2023 Class II | DeRoyal SHOULDER KIT, REF 89-9497.08XXX | 11/03/2022Open, Classified |
| Z-0654-2023 Class II | DeRoyal EMERGENT TRAUMA PACK, REF 89-9453.14XXX | 11/03/2022Open, Classified |
| Z-0653-2023 Class II | DeRoyal EMERGENT TRAUMA PACK, REF 89-9453.13XXX | 11/03/2022Open, Classified |
| Z-0652-2023 Class II | DeRoyal EMERGENT TRAUMA PACK, ref 89-9453.12XXX | 11/03/2022Open, Classified |
| Z-0651-2023 Class II | DeRoyal SHOULDER PACK, REF 89-9449.13XXX | 11/03/2022Open, Classified |
| Z-0650-2023 Class II | DeRoyal SHOULDER PACK, REF 89-9449.12XXX | 11/03/2022Open, Classified |
| Z-0649-2023 Class II | DeRoyal ENDOVASCULAR TRACEPACK, REF 89-9350.03XXX | 11/03/2022Open, Classified |
| Z-0648-2023 Class II | DeRoyal MYELOGRAM PACK, REF 89-9304.06DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. | 11/03/2022Open, Classified |
| Z-0647-2023 Class II | DeRoyal MYELOGRAM PACK, REF 89-9304.05XXX | 11/03/2022Open, Classified |
| Z-0646-2023 Class II | DeRoyal TOTAL HIP PACK, REF 89-9301.07XXX | 11/03/2022Open, Classified |
| Z-0645-2023 Class II | DeRoyal TOTAL KNEE PACK, REF 89-9300.08XXX | 11/03/2022Open, Classified |
| Z-0644-2023 Class II | DeRoyal BIOPSY PACK, REF 89-9270.05XXX | 11/03/2022Open, Classified |
| Z-0643-2023 Class II | DeRoyal BIOPSY PACK, REF 89-9270.04XXX | 11/03/2022Open, Classified |
| Z-0642-2023 Class II | DeRoyal NEURO PACK, REF 89-9253.09XXX | 11/03/2022Open, Classified |
| Z-0641-2023 Class II | DeRoyal NEURO PACK, REF 89-9253.07XXX | 11/03/2022Open, Classified |
| Z-0640-2023 Class II | DeRoyal FOOT PACK, REF 89-9252.08XXX | 11/03/2022Open, Classified |
| Z-0639-2023 Class II | DeRoyal FOOT PACK, REF 89-9252.07XXX | 11/03/2022Open, Classified |
| Z-0638-2023 Class II | DeRoyal FOOT PACK, REF 89-9252.06XXX | 11/03/2022Open, Classified |
| Z-0637-2023 Class II | DeRoyal MAJOR ORTHO PACK, REF 89-9250.07XXX | 11/03/2022Open, Classified |
| Z-0636-2023 Class II | DeRoyal BASIC EYE PACK, REF 89-9233.08XXX | 11/03/2022Open, Classified |
| Z-0635-2023 Class II | DeRoyal TOTAL HIP PACK, REF 89-9113.07XXX | 11/03/2022Open, Classified |
| Z-0634-2023 Class II | DeRoyal TOTAL HIP PACK, REF 89-9113.06XXX | 11/03/2022Open, Classified |
| Z-0633-2023 Class II | DeRoyal LAMINECTOMY SPINAL FUSION PACK, REF 89-9105.10XXX | 11/03/2022Open, Classified |
| Z-0632-2023 Class II | DeRoyal LAMINECTOMY SPINAL FUSION PACK, REF 89-9105.09XXX | 11/03/2022Open, Classified |
| Z-0631-2023 Class II | DeRoyal LAMINECTOMY SPINAL FUSION PACK, REF 89-9105.08XXX | 11/03/2022Open, Classified |
| Z-0630-2023 Class II | DeRoyal KIT HEART B PACK, REF 89-9042.08XXX | 11/03/2022Open, Classified |
| Z-0629-2023 Class II | DeRoyal KIT HEART B PACK, REF 89-9042.07XXX | 11/03/2022Open, Classified |
| Z-0628-2023 Class II | DeRoyal KIT EXTREMITY PACK, REF 89-8869.09XXX | 11/03/2022Open, Classified |
| Z-0627-2023 Class II | DeRoyal KIT TOTAL HIP, REF 89-8861.07DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. | 11/03/2022Open, Classified |
| Z-0626-2023 Class II | DeRoyal TLIF PACK, REF 89-8780.04DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. | 11/03/2022Open, Classified |
| Z-0625-2023 Class II | DeRoyal ACDF PACK, REF 89-8779.03XXX | 11/03/2022Open, Classified |
| Z-0624-2023 Class II | DeRoyal SHOULDER ARTHROSCOPY PACK, REF 89-8777.04XXX | 11/03/2022Open, Classified |
| Z-0623-2023 Class II | DeRoyal EYE PACK, REF 89-8756.03XXX | 11/03/2022Open, Classified |
| Z-0622-2023 Class II | GEO-MED BIOPSY TRAY, REF 89-8753.01XXX | 11/03/2022Open, Classified |
| Z-0621-2023 Class II | DeRoyal PORT PACK PGYBK, REF 89-8748.05XXX | 11/03/2022Open, Classified |
| Z-0620-2023 Class II | GEO-MED PODIATRY PACK PGYBK, REF 89-8700.02XXX | 11/03/2022Open, Classified |
| Z-0619-2023 Class II | GEO-MED PODIATRY PACK PGYBK, REF 89-8700.01XXX | 11/03/2022Open, Classified |
| Z-0618-2023 Class II | DeRoyal BASIC PACK, REF 89-8633.07XXX | 11/03/2022Open, Classified |
| Z-0617-2023 Class II | DeRoyal CUSTOM NEURO PACK, REF 89-8392.10XXX | 11/03/2022Open, Classified |
| Z-0616-2023 Class II | DeRoyal CUSTOM NEURO PACK, REF 89-8392.09DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. | 11/03/2022Open, Classified |
| Z-0615-2023 Class II | DeRoyal SPINE PACK, REF 89-8361.10DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. | 11/03/2022Open, Classified |
| Z-0614-2023 Class II | DeRoyal SPINE PACK, REF 89-8361.09DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. | 11/03/2022Open, Classified |
| Z-0613-2023 Class II | DeRoyal SPINE PACK, REF 89-8361.08XXX | 11/03/2022Open, Classified |
| Z-0612-2023 Class II | DeRoyal PODIATRY PACK, REF 89-8359.13XXX | 11/03/2022Open, Classified |
| Z-0611-2023 Class II | DeRoyal PODIATRY PACK, REF 89-8359.10XXX | 11/03/2022Open, Classified |
| Z-0610-2023 Class II | DeRoyal HEART PACK, REF 89-8351.13XXX | 11/03/2022Open, Classified |
| Z-0609-2023 Class II | DeRoyal HEART PACK, REF 89-8351.12DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. | 11/03/2022Open, Classified |
| Z-0608-2023 Class II | DeRoyal HEART PACK, REF 89-8351.11XXX | 11/03/2022Open, Classified |
| Z-0607-2023 Class II | DeRoyal BASIC EYE PACK, REF 89-8337.09XXX | 11/03/2022Open, Classified |
| Z-0606-2023 Class II | DeRoyal BASIC EYE PACK, REF 89-8337.08XXX | 11/03/2022Open, Classified |
| Z-0605-2023 Class II | GEO-MED UPPER EXTERMITY PACK, REF 89-8253.02XXX | 11/03/2022Open, Classified |
| Z-0604-2023 Class II | GEO-MED LOWER EXTERMITY PACK, REF 89-8252.02DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. | 11/03/2022Open, Classified |
| Z-0603-2023 Class II | DeRoyal EYE TRAY PGYBK, REF 89-7978.02DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. | 11/03/2022Open, Classified |
| Z-0602-2023 Class II | DeRoyal ENDOVENOUS PACK, REF 89-7762.05DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. | 11/03/2022Open, Classified |
| Z-0601-2023 Class II | DeRoyal ORTHO SPINE BACK PACK, REF 89-7534.09XXX | 11/03/2022Open, Classified |
| Z-0600-2023 Class II | DeRoyal BASIC NEURO PACK, REF 89-7523.16XXX | 11/03/2022Open, Classified |
| Z-0599-2023 Class II | DeRoyal BASIC NEURO PACK, REF 89-7523.15XXX | 11/03/2022Open, Classified |
| Z-0598-2023 Class II | DeRoyal SPINAL FUSION PACK, REF 89-7515.14DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. | 11/03/2022Open, Classified |
| Z-0597-2023 Class II | DeRoyal SPINAL FUSION PACK, REF 89-7515.13DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. | 11/03/2022Open, Classified |
| Z-0596-2023 Class II | DeRoyal SPINAL FUSION PACK, REF 89-7515.12DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. | 11/03/2022Open, Classified |
| Z-0595-2023 Class II | DeRoyal CUSTOM NEURO PACK, REF 89-7353.17XXX | 11/03/2022Open, Classified |
| Z-0594-2023 Class II | DeRoyal RETINAL PACK, REF 89-7336.07XXX | 11/03/2022Open, Classified |
| Z-0593-2023 Class II | DeRoyal VIT RD PACK 86ST, REF 89-7308.09XXX | 11/03/2022Open, Classified |
| Z-0592-2023 Class II | DeRoyal BASIC NEURO PACK, REF 89-7258.13DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. | 11/03/2022Open, Classified |
| Z-0591-2023 Class II | DeRoyal BASIC NEURO PACK, REF 89-7258.12DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. | 11/03/2022Open, Classified |
| Z-0590-2023 Class II | DeRoyal BASIC NEURO PACK, REF 89-7258.10DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. | 11/03/2022Open, Classified |
| Z-0589-2023 Class II | DeRoyal LAPINECTOMY PACK, REF 89-7198.11XXX | 11/03/2022Open, Classified |
| Z-0588-2023 Class II | DeRoyal LAPINECTOMY PACK, REF 89-7198.10XXX | 11/03/2022Open, Classified |
| Z-0587-2023 Class II | DeRoyal TRANS CANAL PACK, REF 89-7157.12XXX | 11/03/2022Open, Classified |
| Z-0586-2023 Class II | DeRoyal CATARACT PACK, REF 89-7135.10DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. | 11/03/2022Open, Classified |
| Z-0585-2023 Class II | DeRoyal GU ROBOTIC PACK, REF 89-7063.12XXX | 11/03/2022Open, Classified |
| Z-0584-2023 Class II | DeRoyal LAPAROSCOPIC ROBOTIC TRAY, REF 89-7063.11XXX | 11/03/2022Open, Classified |
| Z-0583-2023 Class II | DeRoyal BREAST TRAY, REF 89-7033.07XXX | 11/03/2022Open, Classified |
| Z-0582-2023 Class II | DeRoyal CANNULTED HIP PACK, REF 89-6977.10XXX | 11/03/2022Open, Classified |
| Z-0581-2023 Class II | DeRoyal CANNULTED HIP PACK CSM, REF 89-6977.09DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. | 11/03/2022Open, Classified |
| Z-0580-2023 Class II | DeRoyal CATARACT PACK CSM, REF 89-6863DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. | 11/03/2022Open, Classified |
| Z-0579-2023 Class II | DeRoyal SHOULDER PACK, REF 89-6830.13XXX | 11/03/2022Open, Classified |
| Z-0578-2023 Class II | GEO-MED TOTAL KNEE PACK A & B, REF 89-6799.02XXX | 11/03/2022Open, Classified |
| Z-0577-2023 Class II | GEO-MED PLASTIC HAND PACK RF, REF 89-6667.10XXX | 11/03/2022Open, Classified |
| Z-0576-2023 Class II | GEO-MED PLASTIC HAND PACK RF, REF 89-6667.09XXX | 11/03/2022Open, Classified |
| Z-0575-2023 Class II | DeRoyal OPEN SHOULDER PROCEDURE PACK RF, REF 89-6629.09DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. | 11/03/2022Open, Classified |
| Z-0574-2023 Class II | DeRoyal OPEN SHOULDER PROCEDURE PACK RF, REF 89-6629.07XXX | 11/03/2022Open, Classified |
| Z-0573-2023 Class II | DeRoyal SHOULDER ARTHORSCOPY PACK RF, REF 89-6628.09DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. | 11/03/2022Open, Classified |
| Z-0572-2023 Class II | GEO-MED OPTHALMOLOGY CSTM PCK, REF 89-6387.09DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. | 11/03/2022Open, Classified |
| Z-0571-2023 Class II | GEO-MED OPTHALMOLOGY CSTM PCK, REF 89-6387.08DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. | 11/03/2022Open, Classified |
| Z-0570-2023 Class II | GEO-MED PODIATRY PACK PGYBK, REF 89-6240.05DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. | 11/03/2022Open, Classified |
| Z-0569-2023 Class II | DeRoyal PICC LINE TRAY PGYBK, REF 89-6150.13DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. | 11/03/2022Open, Classified |
| Z-0568-2023 Class II | GEO-MED SHOULDER ARTHROSCOPY KNEE PACK, REF 89-5797.09DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. | 11/03/2022Open, Classified |
| Z-0567-2023 Class II | GEO-MED TOTAL KNEE PACK A & B PGYK, REF 89-5796.13DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. | 11/03/2022Open, Classified |
| Z-0566-2023 Class II | GEO-MED KNEE ARTHROSCOPY PACK, REF 89-5795.07DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. | 11/03/2022Open, Classified |
| Z-0565-2023 Class II | DeRoyal PEDI ORTHO PACK, REF 89-5323.20DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. | 11/03/2022Open, Classified |
| Z-0564-2023 Class II | DeRoyal EYE TRAY, REF 89-4957.08DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. | 11/03/2022Open, Classified |
| Z-0563-2023 Class II | DeRoyal EXTREMITY TRAY PGYBK, REF 89-4081.07DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. | 11/03/2022Open, Classified |
| Z-0562-2023 Class II | DeRoyal EYE PACK, REF 89-4051.09DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. | 11/03/2022Open, Classified |
| Z-0561-2023 Class II | DeRoyal MAJOR ORAL PACK RF, REF 89-3936.15DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. | 11/03/2022Open, Classified |
| Z-0560-2023 Class II | DeRoyal MINOR ORAL / ENT PACK, REF 89-2576.15DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. | 11/03/2022Open, Classified |
| Z-1668-2022 Class II | DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear ConnectorsProcedure packs contained a recalled product. | 08/12/2022Terminated |
| Z-1562-2022 Class II | DeRoyal limb holders: (1) DeRoyal Limb Holder, Wrist, Fixed, Quick Release, REF M8124…The webbing strap was laced improperly through the teeth of the buckle allowing the webbing strap to slide… | 07/15/2022Terminated |
| Z-0880-2022 Class II | DeRoyal DEXMED ACCESS CENTER TRAY, containing Prevantics antiseptic (chlorhexidine…A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to… | 03/03/2022Terminated |
| Z-0879-2022 Class II | DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine gluconate and…A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to… | 03/03/2022Terminated |
| Z-0878-2022 Class II | DeRoyal ST Neonatal Dressing Change Kit, containing Prevantics antiseptic (chlorhexidine…A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to… | 03/03/2022Terminated |
| Z-1834-2021 Class I | DeRoyal Angio Cath Removal Tray, REF 89-9936.02DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lidocaine… | 05/14/2021Terminated |
| Z-1833-2021 Class I | DeRoyal Heart Cath Procedure Pack, REF 89-6556.08DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lidocaine… | 05/14/2021Terminated |
| Z-1832-2021 Class I | DeRoyal Pacemaker Tray Pgybk, REF 89-6360.06DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lidocaine… | 05/14/2021Terminated |
| Z-1140-2021 Class II | Heart Pack, REF numbers: a) 89-9194.07 b) 89-9194.09 c) 89-9194-10 d) 89-9194-11 Custom…Sternum saw blades within procedure packs are not sterile. The surgical saw blade has a green non-sterile… | 01/25/2021Terminated |
| Z-1139-2021 Class II | Open Heart Pack, REF numbers: a) 89-7483.07 b) 89-7483.08 c) 89-7483.09 d) 89-7483.10…Sternum saw blades within procedure packs are not sterile. The surgical saw blade has a green non-sterile… | 01/25/2021Terminated |
| Z-1138-2021 Class II | CV Basin Set Pack, REF numbers: a) 89-7935.11 b) 89-7935.12 c) 89-7935.13 d) 89-7935.14…Sternum saw blades within procedure packs are not sterile. The surgical saw blade has a green non-sterile… | 01/25/2021Terminated |
| Z-1963-2020 Class II | DeRoyal Sterile Custom Kits packaged as a Piggy Back with the BD PosiFlush SF Saline…DeRoyal manufactured procedure packs using BDPosiFlush syringes which were subsequently recalled due holes… | 04/24/2020Terminated |
| Z-1604-2020 Class II | DeRoyal SECURITY CUFFS, Single Strap, QR Buckle Cuff and Bed, UNIVERSAL, REF M8138 -…One lot of product was inadvertently manufactured with a buckle which does not meet the mechanical hold… | 02/27/2020Terminated |
| Z-0706-2020 Class II | DeRoyal KNEE BRACE, WARRIOR RECOVERY: 1) REF KB9000-01 2) REF 11-450A-00 3) REF 1150UTPPThe Warrior Recovery Knee Brace has the potential to come apart due to the hinge breaking. | 11/21/2019Open, Classified |
| Z-2293-2019 Class II | DeRoyal Enteral Safe Feeding Tubes: a) REF 54-2450R, 5 FR x 24" Polyurethane b) REF…Certain MED-RX Polyurethane Feeding Tubes are being recalled due to a product concern where the connector… | 07/22/2019Terminated |
| Z-1981-2019 Class II | DeRoyal THE RESOURCE GROUP, CRANI PACK, REF 89-9211.07 custom surgical packCustom surgical packs are being recalled because it contains Cardinal Health Blunt Cannulas which were… | 06/18/2019Terminated |
| Z-0746-2019 Class II | DeRoyal(R) Enteral Safe Feed Tube, REF 54-2465 A Nasogastric/Oralgastric enteral feeding…Enteral Safe Feeding Tubes labeled as 6.5 FR X 24" contained 5 FR X 24" Enteral Safe Feeding Tubes. | 12/17/2018Terminated |
| Z-1583-2018 Class II | DeRoyal(R) SURGI MATE(R) Electrosurgical Pencil, Button Switch, with 15 ft (4.6 m) Cord…Non-sterile product was packaged inside a case that was labeled as sterile. | 04/23/2018Terminated |
| Z-0637-2018 Class II | Custom sterile surgical packs labeled as follows: GEO-MED CABG PACK PGYBK A & B, REF…DeRoyal manufactured custom sterile surgical kits containing the Terumo Over Pressure Safety Valve, which… | 01/22/2018Terminated |
| Z-0334-2018 Class II | DeRoyal Sterile Custom kits containing Covidien-Dover(TM) Irrigation Tray with Piston…DeRoyal manufactured custom sterile surgical kits containing the Covidien-Dover(TM) Irrigation Tray with… | 12/19/2017Terminated |
| Z-0199-2018 Class II | DeRoyal Sterile Custom kits containing Medline Aplicare Povidone Iodine Prep Pads: a)…Custom surgical kits contain Aplicare Povidone Iodine Prep Pads which were subsequently recalled by Medline… | 10/16/2017Terminated |
| Z-2639-2017 Class II | DeRoyal(R) Dolphin Inflation Device, REF 0185ND, Rx Only, STERILE EO, Dolphin is an…Lack of sterility assurance. There is a defect in the primary packaging of the device, which may compromise… | 06/07/2017Terminated |
| Z-1248-2017 Class III | SRHS DeRoyal Heart Tracecart REF 53-1913, Rx Only, NON-STERILE PRODUCT CONTAINED WITHIN.DeRoyal manufactured custom tracecarts containing a sterile Maquet Getinge Group chest drainage product… | 01/25/2017Terminated |