FDA Device Recalls

Recalls / Firms / DeRoyal Industries Inc

DeRoyal Industries Inc

234 FDA device recalls on record.

DateClassProductReason
2025-01-31DeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF 71-C6100NS Tubing, Suction, Connecto
2025-01-15DeRoyal AMG Suction Connector Tubing REF: 71-2083, 71-C506, 71-C510, 71-C512, 71-C520, Tubin
2024-10-03DeRoyal C-SECTION TRACEPACK, REF 89-9338-06
2024-10-03DeRoyal CHILDREN'S LAPTRACEPACK, 89-9362.06
2024-10-03DeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-06
2024-10-03DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06
2024-02-13GeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECART, b) 53-1836 GENERAL S
2023-11-22DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572
2023-09-18DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit
2023-05-30Custom medical procedure packs labeled as: a) PELVIC EXAM TRAY, REF 89-6219
2023-05-30Custom medical procedure packs labeled as: a) STURDI STRAINER TRAY STANDARD, REF '89-5014
2023-05-30Custom medical procedure packs labeled as: a) STANDARD OB PACK ASCENSION WI, REF 89-10640 b) ANGIO
2023-05-30Custom medical procedure packs labeled as: a) OPEN HEART TRACECART, REF '53-1941; b) CARDIAC CA
2023-05-30Custom medical procedure packs labeled as: a) CATH ANGIOGRAPHY DRAPE PACK, REF 89-7102; b) CHOLA
2023-04-17Sterile custom surgical procedure packs (1) 89-10529.04, CNRV OR C-SECTION PACK, New River Valley
2023-04-17Sterile custom surgical procedure packs: (1) 89-10507.02, TOTAL KNEE PACK, Stonewall Jackson Hospit
2023-02-09DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000B
2022-12-12DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10
2022-11-28DeRoyal Tonsillectomy Tray, REF 89-10698.01
2022-11-03DeRoyal PICC LINE TRAY PGYBK, REF 89-6150.13
2022-11-03DeRoyal NEURO PACK, REF 89-9253.09
2022-11-03DeRoyal SHOULDER KIT, REF 89-9497.08
2022-11-03DeRoyal CATARACT PACK CSM, REF 89-6863
2022-11-03DeRoyal SHOULDER ARTHORSCOPY PACK RF, REF 89-6628.09
2022-11-03DeRoyal CATARACT PACK, REF 89-10040.01
2022-11-03DeRoyal LAMI/CRANI PACK, REF 89-10787.01
2022-11-03DeRoyal TRACECART SHOULDER ARTHROSCOPY TRACECART, REF 53-1962.02
2022-11-03DeRoyal ORTHO SPINE BACK PACK, REF 89-7534.09
2022-11-03DeRoyal EYE PACK, REF 89-4051.09
2022-11-03DeRoyal TOTAL SHOULDER PACK, REF 89-10151.05
2022-11-03DeRoyal NEURO PACK, REF 89-10682.02
2022-11-03DeRoyal FOOT PACK, REF 89-9252.06
2022-11-03DeRoyal PAIN TRAY, REF 89-10464.02
2022-11-03DeRoyal GU PACK, REF 89-10665.03
2022-11-03DeRoyal BIOPSY PACK, REF 89-9270.04
2022-11-03DeRoyal BASIC EYE PACK, REF 89-9233.08
2022-11-03DeRoyal POSTERIOR LUMBAR FUSION PACK, REF 89-10060.02
2022-11-03DeRoyal OPEN SHOULDER PROCEDURE PACK RF, REF 89-6629.07
2022-11-03GEO-MED OPTHALMOLOGY CSTM PCK, REF 89-6387.08
2022-11-03DeRoyal PAIN TRAY, REF 89-10464.03
2022-11-03GEO-MED PODIATRY PACK PGYBK, REF 89-8700.01
2022-11-03GEO-MED OPTHALMOLOGY CSTM PCK, REF 89-6387.09
2022-11-03DeRoyal PORT PACK PGYBK, REF 89-8748.05
2022-11-03DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-10820.02
2022-11-03DeRoyal ENDOVENOUS PACK, REF 89-7762.05
2022-11-03GEO-MED TOTAL KNEE PACK A & B PGYK, REF 89-5796.13
2022-11-03DeRoyal CATARACT PACK, REF 89-8859.08
2022-11-03DeRoyal BASIC NEURO PACK, REF 89-7523.15
2022-11-03DeRoyal EMERGENT TRAUMA PACK, ref 89-9453.12
2022-11-03GEO-MED PLASTIC HAND PACK RF, REF 89-6667.10
2022-11-03DeRoyal KIT HEART B PACK, REF 89-9042.08
2022-11-03DeRoyal TOTAL KNEE PACK A & B PACK, REF 89-6799.02
2022-11-03DeRoyal RETINAL PACK, REF 89-7336.07
2022-11-03DeRoyal NEURO PACK, REF 89-10171.06
2022-11-03DeRoyal ACDF PACK, REF 89-8779.03
2022-11-03DeRoyal PEDI ORTHO PACK, REF 89-5323.20
2022-11-03DeRoyal LAPINECTOMY PACK, REF 89-7198.10
2022-11-03DeRoyal CNRV PERIPHERAL VAS PACK, REF 89-10530.03
2022-11-03GEO-MED KNEE ARTHROSCOPY PACK, REF 89-5795.07
2022-11-03DeRoyal CRANI PACK, REF 89-10202.05
2022-11-03DeRoyal LUMBAR DISC PACK, REF 89-10605.02
2022-11-03GEO-MED PODIATRY PACK PGYBK, REF 89-8700.02
2022-11-03DeRoyal OPEN SHOULDER PROCEDURE PACK RF, REF 89-6629.09
2022-11-03DeRoyal SHOULDER KIT, REF 89-9497.10
2022-11-03DeRoyal SHOULDER ARTHROSCOPY PACK, REF 89-8777.04
2022-11-03DeRoyal BIOPSY PACK, REF 89-9270.05
2022-11-03DeRoyal BIOPSY PACKPACK, REF 89-9756.05
2022-11-03DeRoyal HAND PACK, REF 89-10314.02
2022-11-03GEO-MED BIOPSY TRAY, REF 89-8753.01
2022-11-03DeRoyal KIT TOTAL HIP, REF 89-8861.07
2022-11-03DeRoyal LAMINECTOMY SPINAL FUSION PACK, REF 89-9105.10
2022-11-03GEO-MED UPPER EXTERMITY PACK, REF 89-8253.02
2022-11-03DeRoyal VIT RD PACK 86ST, REF 89-7308.09
2022-11-03DeRoyal CANNULTED HIP PACK, REF 89-6977.10
2022-11-03DeRoyal SPINAL FUSION PACK, REF 89-7515.12
2022-11-03DeRoyal BASIC NEURO PACK, REF 89-7523.16
2022-11-03DeRoyal SHOULDER PACK, REF 89-9449.12
2022-11-03DeRoyal KIT EXTREMITY PACK, REF 89-8869.09
2022-11-03DeRoyal NEURO PACK, REF 89-10171.05
2022-11-03GEO-MED PODIATRY PACK PGYBK, REF 89-6240.05
2022-11-03DeRoyal TRACECART POSTEROR LUMBAR FUSION TRACECART, REF 53-1961.02
2022-11-03DeRoyal CRANI PACK, REF 89-10242.04
2022-11-03DeRoyal HAND PACK, REF 89-10314.03
2022-11-03DeRoyal TRACECART POSTEROR LAMI MICRODISC TRACECART, REF 53-1960.02
2022-11-03DeRoyal CATARACT PACK, REF 89-7135.10
2022-11-03DeRoyal FOOT PACK, REF 89-9252.07
2022-11-03DeRoyal LUMBAR FUSION PACK, REF 89-10211.05
2022-11-03GEO-MED SHOULDER ARTHROSCOPY KNEE PACK, REF 89-5797.09
2022-11-03DeRoyal GU PACK, REF 89-10665.02
2022-11-03DeRoyal BASIC EYE PACK, REF 89-8337.08
2022-11-03DeRoyal NEURO PACK, REF 89-10171.03
2022-11-03DeRoyal SPINAL FUSION PACK, REF 89-7515.13
2022-11-03DeRoyal EYE TRAY PGYBK, REF 89-7978.02
2022-11-03DeRoyal MAJOR ORAL PACK RF, REF 89-3936.15
2022-11-03DeRoyal BIOPSY PACK, REF 89-9614.07
2022-11-03DeRoyal CATARACT PACK, REF 89-10086.05
2022-11-03DeRoyal CARDIAC LINEN PACK, REF 89-10543.02
2022-11-03DeRoyal SPINE PACK, REF 89-8361.08
2022-11-03DeRoyal CMC POSTERIOR SPINE PACK, REF 89-10570.01
2022-11-03DeRoyal GU ROBOTIC PACK, REF 89-7063.12
2022-11-03DeRoyal POSTERIOR LAMI MICRODISC PACK, REF 89-10059.02
2022-11-03DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-9946.04
2022-11-03DeRoyal TRANS CANAL PACK, REF 89-7157.12
2022-11-03DeRoyal TOTAL KNEE PACK, REF 89-9300.08
2022-11-03DeRoyal SPINAL FUSION PACK, REF 89-7515.14
2022-11-03DeRoyal SPINE PACK, REF 89-8361.10
2022-11-03GEO-MED CATARACT PACK, REF 89-5790.08
2022-11-03DeRoyal HEART PACK, REF 89-8351.12
2022-11-03DeRoyal KIT HEART B PACK, REF 89-9042.07
2022-11-03DeRoyal EMERGENT TRAUMA PACK, REF 89-9453.14
2022-11-03DeRoyal MYELOGRAM PACK, REF 89-9304.06
2022-11-03DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-10061.02
2022-11-03DeRoyal BASIC PACK, REF 89-8633.07
2022-11-03DeRoyal FOOT PACK, REF 89-9252.08
2022-11-03DeRoyal BASIC EYE PACK, REF 89-8337.09
2022-11-03DeRoyal ACDF PACK PGYBK A PACK / B PACK, REF 89-9997.06
2022-11-03GEO-MED TOTAL KNEE PACK A & B, REF 89-6799.02
2022-11-03DeRoyal LUMBAR/CERVICAL PACK, REF 89-9521.11
2022-11-03DeRoyal CUSTOM NEURO PACK, REF 89-8392.09
2022-11-03DeRoyal PODIATRY PACK, REF 89-8359.13
2022-11-03DeRoyal TLIF PACK, REF 89-8780.04
2022-11-03DeRoyal SPINE PACK, REF 89-8361.09
2022-11-03GEO-MED LOCAL ANESTHESIA PACK, REF 89-10800.01
2022-11-03DeRoyal LAMINECTOMY PACK, REF 89-10209.02
2022-11-03DeRoyal SHOULDER PACK, REF 89-6830.13
2022-11-03DeRoyal ABDOMINOPLASTY W/LIPO PACK, REF 89-9557.03
2022-11-03DeRoyal TOTAL HIP KIT, REF 89-9498.10
2022-11-03DeRoyal LAPINECTOMY PACK, REF 89-7198.11
2022-11-03DeRoyal PODIATRY PACK, REF 89-8359.10
2022-11-03DeRoyal TOTAL HIP PACK, REF 89-9113.07
2022-11-03DeRoyal BREAST AUGMENTATION PACK, REF 89-9618.05
2022-11-03DeRoyal CATARACT PACK, REF 89-9241.03
2022-11-03DeRoyal CNRV SPINAL PACK, REF 89-10532.03
2022-11-03DeRoyal TOTAL HIP KIT, REF 89-9498.08
2022-11-03DeRoyal EYE TRAY, REF 89-4957.08
2022-11-03DeRoyal CANNULTED HIP PACK CSM, REF 89-6977.09
2022-11-03DeRoyal LAMINECTOMY SPINAL FUSION PACK, REF 89-9105.09
2022-11-03DeRoyal TOTAL HIP PACK, REF 89-9301.07
2022-11-03DeRoyal PACEMAKER ICD PACK, REF 89-10216.03
2022-11-03DeRoyal EXTREMITY TRAY PGYBK, REF 89-4081.07
2022-11-03DeRoyal LAPAROSCOPIC ROBOTIC TRAY, REF 89-7063.11
2022-11-03DeRoyal BIOPSY PACK, REF 89-9739.06
2022-11-03DeRoyal BASIC NEURO PACK, REF 89-7258.10
2022-11-03DeRoyal UNIVERSAL PACK, REF 89-9558.03
2022-11-03DeRoyal BASIC NEURO PACK, REF 89-7258.12
2022-11-03DeRoyal NEURO PACK, REF 89-9253.07
2022-11-03DeRoyal HEART PACK, REF 89-8351.11
2022-11-03DeRoyal CATARACT PACK, REF 89-8650.10
2022-11-03DeRoyal SHOULDER PACK, REF 89-9449.13
2022-11-03DeRoyal CRANI PACK, REF 89-10242.02
2022-11-03GEO-MED PLASTIC HAND PACK RF, REF 89-6667.09
2022-11-03DeRoyal BASIC NEURO PACK, REF 89-7258.13
2022-11-03DeRoyal EMERGENT TRAUMA PACK, REF 89-9453.13
2022-11-03DeRoyal BREAST TRAY, REF 89-7033.07
2022-11-03DeRoyal CUSTOM NEURO PACK, REF 89-7353.17
2022-11-03DeRoyal CRANI PACK, REF 89-10202.03
2022-11-03DeRoyal MAJOR ORTHO PACK, REF 89-9250.07
2022-11-03DeRoyal BIOPSY PACK, REF 89-9739.05
2022-11-03DeRoyal NEURO SPINE BACK PACK PGYBK, REF 89-10853.01
2022-11-03DeRoyal MINOR ORAL / ENT PACK, REF 89-2576.15
2022-11-03DeRoyal MYELOGRAM PACK, REF 89-9304.05
2022-11-03DeRoyal FACIAL PACK PGYBK, REF 89-10007.03
2022-11-03DeRoyal LAMINECTOMY SPINAL FUSION PACK, REF 89-9105.08
2022-11-03DeRoyal CATARACT PACK, REF 89-9241.04
2022-11-03DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-10240.03
2022-11-03DeRoyal ANTERIOR APPROACH TOTAL HIP A&B PGYBK, REF 89-10612.01
2022-11-03DeRoyal ENDOVASCULAR TRACEPACK, REF 89-9350.03
2022-11-03DeRoyal PACEMAKER ICD PACK, REF 89-10902.01
2022-11-03DeRoyal PACEMAKER ICD PACK, REF 89-10216.06
2022-11-03DeRoyal TOTAL HIP PACK, REF 89-9113.06
2022-11-03DeRoyal CUSTOM NEURO PACK, REF 89-8392.10
2022-11-03DeRoyal LUMBAR DISC PACK, REF 89-10590.02
2022-11-03DeRoyal HEART PACK, REF 89-8351.13
2022-11-03DeRoyal EYE PACK, REF 89-8756.03
2022-11-03GEO-MED LOWER EXTERMITY PACK, REF 89-8252.02
2022-08-12DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors
2022-07-15DeRoyal limb holders: (1) DeRoyal Limb Holder, Wrist, Fixed, Quick Release, REF M8124; (2) DeRoyal
2022-03-03DeRoyal ST Neonatal Dressing Change Kit, containing Prevantics antiseptic (chlorhexidine gluconate a
2022-03-03DeRoyal DEXMED ACCESS CENTER TRAY, containing Prevantics antiseptic (chlorhexidine gluconate and iso
2022-03-03DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl al
2021-05-14DeRoyal Angio Cath Removal Tray, REF 89-9936.02
2021-05-14DeRoyal Pacemaker Tray Pgybk, REF 89-6360.06
2021-05-14DeRoyal Heart Cath Procedure Pack, REF 89-6556.08
2021-01-25CV Basin Set Pack, REF numbers: a) 89-7935.11 b) 89-7935.12 c) 89-7935.13 d) 89-7935.14 e) 89-7935.
2021-01-25Heart Pack, REF numbers: a) 89-9194.07 b) 89-9194.09 c) 89-9194-10 d) 89-9194-11 Custom surgical
2021-01-25Open Heart Pack, REF numbers: a) 89-7483.07 b) 89-7483.08 c) 89-7483.09 d) 89-7483.10 Custom su
2020-04-24DeRoyal Sterile Custom Kits packaged as a Piggy Back with the BD PosiFlush SF Saline Flush Syringe,
2020-02-27DeRoyal SECURITY CUFFS, Single Strap, QR Buckle Cuff and Bed, UNIVERSAL, REF M8138 - Product Usage:
2019-11-21DeRoyal KNEE BRACE, WARRIOR RECOVERY: 1) REF KB9000-01 2) REF 11-450A-00 3) REF 1150UTPP
2019-07-22DeRoyal Enteral Safe Feeding Tubes: a) REF 54-2450R, 5 FR x 24" Polyurethane b) REF 54-2465R, 6.5 FR
2019-06-18DeRoyal THE RESOURCE GROUP, CRANI PACK, REF 89-9211.07 custom surgical pack
2018-12-17DeRoyal(R) Enteral Safe Feed Tube, REF 54-2465 A Nasogastric/Oralgastric enteral feeding tube. The
2018-04-23DeRoyal(R) SURGI MATE(R) Electrosurgical Pencil, Button Switch, with 15 ft (4.6 m) Cord and Holster,
2018-01-22Custom sterile surgical packs labeled as follows: GEO-MED CABG PACK PGYBK A & B, REF 89-5985.07, STE
2017-12-19DeRoyal Sterile Custom kits containing Covidien-Dover(TM) Irrigation Tray with Piston Syringe Contai
2017-10-16DeRoyal Sterile Custom kits containing Medline Aplicare Povidone Iodine Prep Pads: a) Incision and D
2017-06-07DeRoyal(R) Dolphin Inflation Device, REF 0185ND, Rx Only, STERILE EO, Dolphin is an inflation devi
2017-01-25DeRoyal Heart Tracecart REF 53-1769, Rx Only, NON-STERILE PRODUCT CONTAINED WITHIN.
2017-01-25SRHS DeRoyal Heart Tracecart REF 53-1913, Rx Only, NON-STERILE PRODUCT CONTAINED WITHIN.
2016-11-07TENNIS ELBOW SUPPORT, PneuGel(TM), UNIVERSAL, REF 200A10, QTY: 1 Each, Rx Only, Product Usage: Lat
2016-11-07PNEUGEL(R) TENNIS ELBOW STRAP, UNIVERSAL, REF 12840000, QTY: 1 Each, Rx Only, Product Usage: Later
2016-08-11DeRoyal (R) CYSTO TRAY PGYBK REF 89-3076.08, Rx Only, STERILE,EO; Custom surgical kit. O,
2016-08-11Geo-Med, TURP/CYSTO PACK PGYBK REF 89-7931.07, Rx Only, STERILE EO, Custom surgical kit.
2015-10-14HYDRO-TEMP(R) Neonatal Temperature Skin Sensor, REF HNICU-32, 50 units per box, NON STERILE, Rx only
2015-09-10DeRoyal sterile custom surgical kits: 1) Emergency CABG Pack Pgybk, ref 89-7859.01 2) Emergency CABG
2015-08-31DeRoyal Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630
2015-08-31DeRoyal Sterile Custom Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, C
2015-04-27Custom Surgical Kits containing Medtronic Covidien Devon(TM) Light Gloves: ANGIO TRAY, REF 50-12127
2015-04-17DeRoyal(R) Medium Specimen Retrieval Bag, REF 5500-000-003, Rx Only Product Usage: The device is
2014-08-22DeRoyal(R) SafeLiner Suction Canister Kit, SEMI-RIGID, 1000cc, REF 71-6518, NON-STERILE, Rx Only,
2014-08-22Suction canisters labels as follows: 1) DeRoyal(R) SUCTION CANISTER, 1000cc, SEMI-RIGID, REF 71-6510
2014-06-04DeRoyal Cardiac Hypothermia Tray, REF 50-9422.07, 1 Per Pack, Distributed by: DeRoyal Industries,
2014-06-04DeRoyal KNEE ARTHROSCOPY PACK, REF 89-6192.04, 1 Per Pack, Distributed by: DeRoyal Industries, Inc
2014-02-21DeRoyal(R) LIMB HOLDERS, COTTON ADJUSTABLE, UNIVERSAL, REF M2017 Product Usage: Limb holders are
2014-01-16DeRoyal ST. Circumcision Clamp, REF 32-1622, Size 1.3 cm, 1 Per Pack, Rx Only STERILE EO, distribut
2013-09-17DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blnkt NS, REF T653NS, Rx only, Ma
2013-09-17DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blanket NS, REF T652NS, Rx only,
2013-09-17Aquarius (TM) TEMPERATURE THERAPY, REF T650, Rx Only, Manufactured for DeRoyal Industries, Inc. 200
2013-09-17DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Shoulder Blanket w/ Straps NS, REF T655NS, Rx o
2013-09-17DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Foot/Ankle Blanket NS, REF T656NS, Rx only, Man
2013-09-17DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee Blanket w/ Straps NS, REF T654NS, Rx only,
2013-08-12DeRoyal (R) Surgical Eye Spears, REF 30-049, Sterile EO, Manufacturer: DeRoyal Industries, Inc. 200
2013-07-15DeRoyal Insufflation Tubing sets: 1) REF 28-0206 Insufflation Tubing, Laparoscopic Rx Only 2) REF 28
2013-05-30GEO-MED ORTHO TOTAL JOINT TRACECART(R), REF 53-1831.07, Rx Only, NON-STERILE Product Usage: genera
2012-06-16Custom surgical kits and trays: GEO-MED TOTAL KNEE PACK PGYBK, REF 89-6664.04 GEO-MED TOTAL HIP PACK
2012-01-20DeRoyal (R) Umbilicup, REF 72-8000, Rx Only, STERILE EO, Manufactured by DeRoyal, Powell, TN 37849
2012-01-20Sterile surgical kits containing the Umbilicup device: DeRoyal (R) VAGINAL DELIVERY PACK, REF 89-526
2012-01-20DeRoyal (R) Umbilicup, REF 72-8000NS, Rx Only, Manufactured by DeRoyal, Powell, TN 37849 Product
2011-06-14Sterile surgical kits: DeRoyal SELECTIVE ARTERIOGRAM PACK, REF 89-7284.02 Lot Number: 26166359; D
2010-07-01NOVAPLUS (TM), SUCTION CANISTER, 1200cc, RIGID, WITH ELBOW, Cat. No. V71-3001, Rx only, NON-STERILE,
2009-12-09DeRoyal TOTAL KNEE TRACECART, REF 53-1818.13, Rx ONLY, NON-STERILE. Custom surgical kit containing
2009-12-09DeRoyal TOTAL HIP TRACECART, REF 53-1820.14, Rx ONLY, NON-STERILE. Custom surgical kit containing S
2008-10-01DeRoyal Lap Chole Tray, REF 89-4823.06, Rx, Sterile EO. (custom surgical kit)
2008-10-01DeRoyal Lap Appy TraceCart, REF53-1776, Rx only, non-sterile. (custom surgical kit)