DeRoyal Industries Inc

FDA Regulatory Profile

Summary

Total Recalls
225 (4 Class I)
510(k) Clearances
92
Inspections
26
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1291-2025Class IIDeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF 71-C6100NS Tubing, Suction, ConnectoJanuary 31, 2025
Z-1174-2025Class IIDeRoyal AMG Suction Connector Tubing REF: 71-2083, 71-C506, 71-C510, 71-C512, 71-C520, TubinJanuary 15, 2025
Z-0307-2025Class IIDeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-06October 3, 2024
Z-0306-2025Class IIDeRoyal C-SECTION TRACEPACK, REF 89-9338-06October 3, 2024
Z-0309-2025Class IIDeRoyal CHILDREN'S LAPTRACEPACK, 89-9362.06October 3, 2024
Z-0308-2025Class IIDeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06October 3, 2024
Z-1382-2024Class IGeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECART, b) 53-1836 GENERAL SFebruary 13, 2024
Z-0622-2024Class IIDeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572November 22, 2023
Z-0116-2024Class IIDeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kitSeptember 18, 2023
Z-2086-2023Class IICustom medical procedure packs labeled as: a) OPEN HEART TRACECART, REF '53-1941; b) CARDIACMay 30, 2023
Z-2090-2023Class IICustom medical procedure packs labeled as: a) CATH ANGIOGRAPHY DRAPE PACK, REF 89-7102; b) CHOMay 30, 2023
Z-2089-2023Class IICustom medical procedure packs labeled as: a) PELVIC EXAM TRAY, REF 89-6219May 30, 2023
Z-2088-2023Class IICustom medical procedure packs labeled as: a) STANDARD OB PACK ASCENSION WI, REF 89-10640 b) ANGMay 30, 2023
Z-2087-2023Class IICustom medical procedure packs labeled as: a) STURDI STRAINER TRAY STANDARD, REF '89-5014May 30, 2023
Z-1692-2023Class IISterile custom surgical procedure packs (1) 89-10529.04, CNRV OR C-SECTION PACK, New River ValleApril 17, 2023
Z-1691-2023Class IISterile custom surgical procedure packs: (1) 89-10507.02, TOTAL KNEE PACK, Stonewall Jackson HospApril 17, 2023
Z-1283-2023Class IIDeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000BFebruary 9, 2023
Z-0927-2023Class IIDeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10December 12, 2022
Z-0906-2023Class IIDeRoyal Tonsillectomy Tray, REF 89-10698.01November 28, 2022
Z-0570-2023Class IIGEO-MED PODIATRY PACK PGYBK, REF 89-6240.05November 3, 2022

Recent 510(k) Clearances

K-NumberDeviceDate
K250586Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam AccessoryNovember 21, 2025
K230233Prospera Spectruum Negative Pressure Wound Therapy SystemApril 18, 2024
K200631DeRoyal Temperature Monitoring ProbeDecember 23, 2020
K200757Foley Catheter with Temperature SensorOctober 15, 2020
K200319HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature SeApril 2, 2020
K193027Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French,April 2, 2020
K191425Hydro-Temp Neonatal Skin Temperature Probe CoverJanuary 21, 2020
K173072Algidex Ag Silver Alginate Wound DressingApril 4, 2018
K171475DeRoyal Laprador Specimen Retrieval SystemAugust 17, 2017
K152978DeRoyal Angiography KitsMarch 25, 2016
K142962PROTOCOL Incision DressingJuly 23, 2015
K131292DEROYAL SPINE SPACER SYSTEMFebruary 3, 2014
K132199DEROYAL ELECTROSURGICAL PENCIL, ROCKER STYLE WITHOUT HOLSTER, DEROYAL ELECTROSURGICAL PENCIL, BUTTONOctober 3, 2013
K090975DEROYAL NON-LOCKING BONE FIXATION SYSTEMApril 12, 2010
K092317DEROYAL NON-STERILE LOCKING COMPRESSION PLATE SYSTEMNovember 2, 2009
K023591ULTRA HIGH PRESSURE INJECTOR LINESJune 18, 2003
K030365DEROYAL DRAPES, STERILE, NON-STERILEApril 29, 2003
K030364DEROYAL GOWNS, STERILE, NON-STERILEApril 28, 2003
K991525DEROYAL STERILE NEONATAL BLOOD PRESSURE CUFFJuly 20, 1999
K983750DEROYAL INDUSTRIES, INC TRACECART SHARPS COLLECTION CONTAINERNovember 30, 1998