Medical DeviceDec 21, 2022
DeRoyal CATARACT PACK, REF 89-10086.05 recall — FDA Z-0715-2023
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
Class IIFDA: OngoingDeRoyal Industries Inc.
Recall history in this database
Classification mix: Class II: 75, Class I: 3, Class III: 2.
Medical DeviceDec 21, 2022
DeRoyal Industries GEO-MED PODIATRY PACK PGYBK, REF 89-6240.05 recall — FDA Z-0570-2023
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
Class IIFDA: OngoingDeRoyal Industries Inc.
Medical DeviceDec 21, 2022
DeRoyal CRANI PACK, REF 89-10242.04 recall — FDA Z-0684-2023
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
Class IIFDA: OngoingDeRoyal Industries Inc.
Medical DeviceAug 31, 2022
DeRoyal limb holders: (1) DeRoyal Limb Holder, Wrist, Fixed, Quick Release, REF M8124 recall — FDA Z-1562-2022
The webbing strap was laced improperly through the teeth of the buckle allowing the webbing strap to slide and was, therefore, not secure.
Class IIFDA: TerminatedDeRoyal Industries Inc.
Medical DeviceApr 13, 2022
DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic recall — FDA Z-0879-2022
A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.
Class IIFDA: TerminatedDeRoyal Industries Inc.
Medical DeviceApr 13, 2022
DeRoyal ST Neonatal Dressing Change Kit, containing Prevantics antiseptic recall — FDA Z-0878-2022
A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.
Class IIFDA: TerminatedDeRoyal Industries Inc.
Medical DeviceApr 13, 2022
DeRoyal DEXMED ACCESS CENTER TRAY, containing Prevantics antiseptic recall — FDA Z-0880-2022
A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.
Class IIFDA: TerminatedDeRoyal Industries Inc.
Medical DeviceJun 16, 2021
DeRoyal Angio Cath Removal Tray, REF 89-9936.02 recall — FDA Z-1834-2021
DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lidocaine which was subsequently recalled due to mislabeling; the product is 0.5% Bupivacaine
Class IFDA: TerminatedDeRoyal Industries Inc.
Medical DeviceJun 16, 2021
DeRoyal Heart Cath Procedure Pack, REF 89-6556.08 recall — FDA Z-1833-2021
DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lidocaine which was subsequently recalled due to mislabeling; the product is 0.5% Bupivacaine
Class IFDA: TerminatedDeRoyal Industries Inc.
Medical DeviceJun 16, 2021
DeRoyal Pacemaker Tray Pgybk, REF 89-6360.06 recall — FDA Z-1832-2021
DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lidocaine which was subsequently recalled due to mislabeling; the product is 0.5% Bupivacaine
Class IFDA: TerminatedDeRoyal Industries Inc.
Medical DeviceMar 3, 2021
DeRoyal Industries Open Heart Pack, REF numbers: a) 89-7483.07 b) 89-7483.08 c) 89-7483.09 recall — FDA Z-1139-2021
Sternum saw blades within procedure packs are not sterile. The surgical saw blade has a green non-sterile sticker.
Class IIFDA: TerminatedDeRoyal Industries Inc.
Medical DeviceMar 3, 2021
DeRoyal Industries CV Basin Set Pack, REF numbers: a) 89-7935.11 b) 89-7935.12 c) 89-7935.13 recall — FDA Z-1138-2021
Sternum saw blades within procedure packs are not sterile. The surgical saw blade has a green non-sterile sticker.
Class IIFDA: TerminatedDeRoyal Industries Inc.
Medical DeviceMar 3, 2021
DeRoyal Industries Heart Pack, REF numbers: a) 89-9194.07 b) 89-9194.09 c) 89-9194-10 d) recall — FDA Z-1140-2021
Sternum saw blades within procedure packs are not sterile. The surgical saw blade has a green non-sterile sticker.
Class IIFDA: TerminatedDeRoyal Industries Inc.
Medical DeviceMay 20, 2020
DeRoyal Sterile Custom Kits packaged as a Piggy Back with the BD PosiFlush SF Saline Flush recall — FDA Z-1963-2020
DeRoyal manufactured procedure packs using BDPosiFlush syringes which were subsequently recalled due holes in the packaging.
Class IIFDA: TerminatedDeRoyal Industries Inc.
Medical DeviceApr 8, 2020
DeRoyal SECURITY CUFFS, Single Strap, QR Buckle Cuff and Bed, UNIVERSAL, REF M8138 - Product recall — FDA Z-1604-2020
One lot of product was inadvertently manufactured with a buckle which does not meet the mechanical hold force required for this device.
Class IIFDA: TerminatedDeRoyal Industries Inc.
Medical DeviceDec 25, 2019
DeRoyal KNEE BRACE, WARRIOR RECOVERY: 1) REF KB9000-01 2) REF 11-450A-00 3) REF 1150UTPP recall — FDA Z-0706-2020
The Warrior Recovery Knee Brace has the potential to come apart due to the hinge breaking.
Class IIFDA: OngoingDeRoyal Industries Inc.
Medical DeviceAug 28, 2019
DeRoyal Enteral Safe Feeding Tubes: a) REF 54-2450R, 5 FR x 24" Polyurethane b) REF recall — FDA Z-2293-2019
Certain MED-RX Polyurethane Feeding Tubes are being recalled due to a product concern where the connector has detached from the feeding tube.
Class IIFDA: TerminatedDeRoyal Industries Inc.
Medical DeviceJul 24, 2019
DeRoyal THE RESOURCE GROUP, CRANI PACK, REF 89-9211.07 custom surgical pack recall — FDA Z-1981-2019
Custom surgical packs are being recalled because it contains Cardinal Health Blunt Cannulas which were recalled due to a manufacturing defect in the cartridge component which could…
Class IIFDA: TerminatedDeRoyal Industries Inc.
Medical DeviceJan 23, 2019
DeRoyal Industries DeRoyal(R) Enteral Safe Feed Tube, REF 54-2465 A Nasogastric/Oralgastric recall — FDA Z-0746-2019
Enteral Safe Feeding Tubes labeled as 6.5 FR X 24" contained 5 FR X 24" Enteral Safe Feeding Tubes.
Class IIFDA: TerminatedDeRoyal Industries Inc.
Medical DeviceFeb 28, 2018
DeRoyal Industries Custom sterile surgical packs labeled as follows: GEO-MED CABG PACK PGYBK recall — FDA Z-0637-2018
DeRoyal manufactured custom sterile surgical kits containing the Terumo Over Pressure Safety Valve, which were subsequently recalled by Terumo CVS due to reports of 'No Flow' through the…
Class IIFDA: TerminatedDeRoyal Industries Inc.
Medical DeviceJan 24, 2018
DeRoyal Sterile Custom kits containing Covidien-Dover(TM) Irrigation Tray with Piston recall — FDA Z-0334-2018
DeRoyal manufactured custom sterile surgical kits containing the Covidien-Dover(TM) Irrigation Tray with Piston Syringe that contains the Medline Aplicare Povidone Iodine Prep Pads. The…
Class IIFDA: TerminatedDeRoyal Industries Inc.
Medical DeviceDec 13, 2017
DeRoyal Sterile Custom kits containing Medline Aplicare Povidone Iodine Prep Pads: a) recall — FDA Z-0199-2018
Custom surgical kits contain Aplicare Povidone Iodine Prep Pads which were subsequently recalled by Medline Industries for incorrect expiration date.
Class IIFDA: TerminatedDeRoyal Industries Inc.
Medical DeviceJul 5, 2017
DeRoyal Industries DeRoyal(R) Dolphin Inflation Device, REF 0185ND, Rx Only, STERILE EO recall — FDA Z-2639-2017
Lack of sterility assurance. There is a defect in the primary packaging of the device, which may compromise the device sterility
Class IIFDA: TerminatedDeRoyal Industries Inc.
Medical DeviceMar 1, 2017
DeRoyal Heart Tracecart REF 53-1769, Rx Only, NON-STERILE PRODUCT CONTAINED WITHIN recall — FDA Z-1247-2017
DeRoyal manufactured custom tracecarts containing a sterile Maquet Getinge Group chest drainage product which was subsequently recalled due to the current packaging configuration of the…
Class IIIFDA: TerminatedDeRoyal Industries Inc.
Understanding this recall history
This page summarizes recall records in which the official source identifies DeRoyal Industries Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.