DeRoyal Industries Inc
157 recalls on record · Latest: Feb 26, 2025
FDA Devices Moderate Dec 21, 2022
DeRoyal BREAST AUGMENTATION PACK, REF 89-9618.05
FDA Devices Moderate Dec 21, 2022
DeRoyal PODIATRY PACK, REF 89-8359.13
FDA Devices Moderate Dec 21, 2022
DeRoyal LAMINECTOMY SPINAL FUSION PACK, REF 89-9105.09
FDA Devices Moderate Dec 21, 2022
DeRoyal FOOT PACK, REF 89-9252.07
FDA Devices Moderate Dec 21, 2022
DeRoyal NEURO SPINE BACK PACK PGYBK, REF 89-10853.01
FDA Devices Moderate Dec 21, 2022
DeRoyal LAMINECTOMY SPINAL FUSION PACK, REF 89-9105.10
FDA Devices Moderate Dec 21, 2022
DeRoyal NEURO PACK, REF 89-9253.07
FDA Devices Moderate Dec 21, 2022
DeRoyal HAND PACK, REF 89-10314.03
FDA Devices Moderate Dec 21, 2022
DeRoyal PAIN TRAY, REF 89-10464.02
FDA Devices Moderate Dec 21, 2022
DeRoyal PICC LINE TRAY PGYBK, REF 89-6150.13
FDA Devices Moderate Dec 21, 2022
GEO-MED TOTAL KNEE PACK A & B, REF 89-6799.02
FDA Devices Moderate Dec 21, 2022
DeRoyal CARDIAC LINEN PACK, REF 89-10543.02
FDA Devices Moderate Dec 21, 2022
DeRoyal SHOULDER PACK, REF 89-9449.12
FDA Devices Moderate Dec 21, 2022
DeRoyal CANNULTED HIP PACK CSM, REF 89-6977.09
FDA Devices Moderate Dec 21, 2022
DeRoyal BIOPSY PACK, REF 89-9270.04
FDA Devices Moderate Dec 21, 2022
DeRoyal FOOT PACK, REF 89-9252.06
FDA Devices Moderate Dec 21, 2022
DeRoyal SHOULDER ARTHORSCOPY PACK RF, REF 89-6628.09
FDA Devices Moderate Dec 21, 2022
DeRoyal LAMINECTOMY PACK, REF 89-10209.02
FDA Devices Moderate Dec 21, 2022
DeRoyal PODIATRY PACK, REF 89-8359.10
FDA Devices Moderate Dec 21, 2022
DeRoyal PACEMAKER ICD PACK, REF 89-10216.06
FDA Devices Moderate Dec 21, 2022
DeRoyal NEURO PACK, REF 89-10171.03
FDA Devices Moderate Sep 7, 2022
DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors
FDA Devices Moderate Aug 31, 2022
DeRoyal limb holders: (1) DeRoyal Limb Holder, Wrist, Fixed, Quick Release, REF M8124; (2) DeRoyal Limb Holder, Ankle, Fixed, Quick Release, REF …
FDA Devices Moderate Apr 13, 2022
DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin …
FDA Devices Moderate Apr 13, 2022
DeRoyal ST Neonatal Dressing Change Kit, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of th…
FDA Devices Critical Jun 16, 2021
DeRoyal Angio Cath Removal Tray, REF 89-9936.02
FDA Devices Critical Jun 16, 2021
DeRoyal Heart Cath Procedure Pack, REF 89-6556.08
FDA Devices Moderate Mar 3, 2021
Open Heart Pack, REF numbers: a) 89-7483.07 b) 89-7483.08 c) 89-7483.09 d) 89-7483.10 Custom surgical procedure packs including sternum sa…
FDA Devices Moderate Mar 3, 2021
CV Basin Set Pack, REF numbers: a) 89-7935.11 b) 89-7935.12 c) 89-7935.13 d) 89-7935.14 e) 89-7935.15 f) 89-7935.16 Custom surgical proce…
FDA Devices Moderate Mar 3, 2021
Heart Pack, REF numbers: a) 89-9194.07 b) 89-9194.09 c) 89-9194-10 d) 89-9194-11 Custom surgical procedure packs including sternum saw blade…
FDA Devices Moderate May 20, 2020
DeRoyal Sterile Custom Kits packaged as a Piggy Back with the BD PosiFlush SF Saline Flush Syringe, labeled as follows: a. H* Vein Pack Pgybk, 89-62…
FDA Devices Moderate Dec 25, 2019
DeRoyal KNEE BRACE, WARRIOR RECOVERY: 1) REF KB9000-01 2) REF 11-450A-00 3) REF 1150UTPP
FDA Devices Moderate Jul 24, 2019
DeRoyal THE RESOURCE GROUP, CRANI PACK, REF 89-9211.07 custom surgical pack
FDA Devices Moderate Jan 24, 2018
DeRoyal Sterile Custom kits containing Covidien-Dover(TM) Irrigation Tray with Piston Syringe Containing Medline Aplicare Povidone Iodine Prep Pads, …
FDA Devices Moderate Dec 13, 2017
DeRoyal Sterile Custom kits containing Medline Aplicare Povidone Iodine Prep Pads: a) Incision and Drainage Tray, REF 47-763.04 b) Incision and Dra…
FDA Devices Moderate Jul 5, 2017
DeRoyal(R) Dolphin Inflation Device, REF 0185ND, Rx Only, STERILE EO, Dolphin is an inflation device indicated during angioplasty procedures to in…
FDA Devices Low Mar 1, 2017
DeRoyal Heart Tracecart REF 53-1769, Rx Only, NON-STERILE PRODUCT CONTAINED WITHIN.
FDA Devices Moderate Dec 14, 2016
TENNIS ELBOW SUPPORT, PneuGel(TM), UNIVERSAL, REF 200A10, QTY: 1 Each, Rx Only, Product Usage: Lateral and medial epicondylitis
FDA Devices Moderate Dec 14, 2016
PNEUGEL(R) TENNIS ELBOW STRAP, UNIVERSAL, REF 12840000, QTY: 1 Each, Rx Only, Product Usage: Lateral and medial epicondylitis
FDA Devices Moderate Sep 7, 2016
Geo-Med, TURP/CYSTO PACK PGYBK REF 89-7931.07, Rx Only, STERILE EO, Custom surgical kit.
FDA Devices Moderate Sep 7, 2016
DeRoyal (R) CYSTO TRAY PGYBK REF 89-3076.08, Rx Only, STERILE,EO; Custom surgical kit. O,
FDA Devices Moderate Dec 9, 2015
DeRoyal sterile custom surgical kits: 1) Emergency CABG Pack Pgybk, ref 89-7859.01 2) Emergency CABG Pack Pgybk, ref 89-7859.02 3) Open Heart Pack…
FDA Devices Moderate Nov 18, 2015
DeRoyal Sterile Custom Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot Nos: 2016-09EE or 2016-09EF,…
FDA Devices Moderate Nov 18, 2015
DeRoyal Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot Nos: 2016-09EE: TOTAL KNEE A & B, REF 8…
FDA Devices Moderate May 27, 2015
DeRoyal(R) Medium Specimen Retrieval Bag, REF 5500-000-003, Rx Only Product Usage: The device is a single-use specimen retrieval bag indicated f…
FDA Devices Moderate Oct 29, 2014
Suction canisters labels as follows: 1) DeRoyal(R) SUCTION CANISTER, 1000cc, SEMI-RIGID, REF 71-6510, NON-STERILE, Rx Only. 2) NOVAPLUS(TM) SUCTION…
FDA Devices Moderate Oct 29, 2014
DeRoyal(R) SafeLiner Suction Canister Kit, SEMI-RIGID, 1000cc, REF 71-6518, NON-STERILE, Rx Only, general hospital
FDA Devices Moderate Aug 6, 2014
DeRoyal KNEE ARTHROSCOPY PACK, REF 89-6192.04, 1 Per Pack, Distributed by: DeRoyal Industries, Inc.; Manufacturer: DeRoyal Industries, Inc.
FDA Devices Moderate Mar 26, 2014
DeRoyal(R) LIMB HOLDERS, COTTON ADJUSTABLE, UNIVERSAL, REF M2017 Product Usage: Limb holders are intended for mildly to moderate agitated or di…
FDA Devices Moderate Mar 12, 2014