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DeRoyal Industries Recalls
226 recalls on record · July 25, 2012 to June 10, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
June 10, 2026Medical DevicesFDA
DeRoyal Industries Inc recalls DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)
Hazard: Sterile wound dressing, lacks sterility assurance
March 12, 2025Medical DevicesFDA
DeRoyal Industries Inc recalls DeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF 71-C6100NS Tubing, Suction, Connector; DeRoyal REF 71-C
Hazard: Due to the inner diameter of the suction tubing connector being smaller than the suction canister lid port connection. This size difference, combined with the durometer of the plastic material, makes the assembly to a suction canister lid port difficult. This could result in inadequate suction and cause a delay in patient care.
February 26, 2025Medical DevicesFDA
DeRoyal Industries Inc recalls DeRoyal AMG Suction Connector Tubing REF: 71-2083, 71-C506, 71-C510, 71-C512, 71-C520, Tubing is intended for fl
Hazard: The tubing may not ensure that the yankauer stays intact, and secure to the tubing / yankauer connection for a tight seal. This could result in inadequate suction and cause delay in patient care.
November 13, 2024Medical DevicesFDA
DeRoyal Industries Inc recalls DeRoyal CHILDREN'S LAPTRACEPACK, 89-9362.06
Hazard: DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pencil. The recall is due to Stryker receiving reports that the pencil is activating without manual input when plugged into a power source or remains active after buttons are released.
November 13, 2024Medical DevicesFDA
DeRoyal Industries Inc recalls DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06
Hazard: DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pencil. The recall is due to Stryker receiving reports that the pencil is activating without manual input when plugged into a power source or remains active after buttons are released.
November 13, 2024Medical DevicesFDA
DeRoyal Industries Inc recalls DeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-06
Hazard: DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pencil. The recall is due to Stryker receiving reports that the pencil is activating without manual input when plugged into a power source or remains active after buttons are released.
November 13, 2024Medical DevicesFDA
DeRoyal Industries Inc recalls DeRoyal C-SECTION TRACEPACK, REF 89-9338-06
Hazard: DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pencil. The recall is due to Stryker receiving reports that the pencil is activating without manual input when plugged into a power source or remains active after buttons are released.
April 3, 2024Medical DevicesFDA
DeRoyal Industries Inc recalls GeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECART, b) 53-1836 GENERAL SURGERY TRACECART
Hazard: DeRoyal manufactured and distributed Surgical Tracecarts that contain a Nurse Assist 16FR Silver Urine Meter Foley which were subsequently recalled.
January 3, 2024Medical DevicesFDA
DeRoyal Industries Inc recalls DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572
Hazard: Kit were manufactured and distributed with Edwards Life Sciences TruWave Disposable pressure transducers which were subsequently recalled by Edwards Life Sciences.
October 25, 2023Medical DevicesFDA
DeRoyal Industries Inc recalls DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit
Hazard: DeRoyal is recalling certain lots of surgical procedure pack products that contain the B.Braun Medical Norm-Ject 2 Piece Syringe. The recall is due to the potential for the sterile packaging barrier to be damaged due to damage to the luer tip of the syringe.
July 12, 2023Medical DevicesFDA
DeRoyal Industries Inc recalls Custom medical procedure packs labeled as: a) CATH ANGIOGRAPHY DRAPE PACK, REF 89-7102; b) CHOLANGIOGRAPHY KIT, RE
Hazard: The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
July 12, 2023Medical DevicesFDA
DeRoyal Industries Inc recalls Custom medical procedure packs labeled as: a) PELVIC EXAM TRAY, REF 89-6219
Hazard: The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
July 12, 2023Medical DevicesFDA
DeRoyal Industries Inc recalls Custom medical procedure packs labeled as: a) STANDARD OB PACK ASCENSION WI, REF 89-10640 b) ANGIO PACK, REF 89-1090
Hazard: The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
July 12, 2023Medical DevicesFDA
DeRoyal Industries Inc recalls Custom medical procedure packs labeled as: a) STURDI STRAINER TRAY STANDARD, REF '89-5014
Hazard: The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
July 12, 2023Medical DevicesFDA
DeRoyal Industries Inc recalls Custom medical procedure packs labeled as: a) OPEN HEART TRACECART, REF '53-1941; b) CARDIAC CATH PACK, REF '89-
Hazard: The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
June 14, 2023Medical DevicesFDA
DeRoyal Industries Inc recalls Sterile custom surgical procedure packs (1) 89-10529.04, CNRV OR C-SECTION PACK, New River Valley Medical Center; an
Hazard: The custom procedure packs contain light handle covers that have been recalled by another firm.
June 14, 2023Medical DevicesFDA
DeRoyal Industries Inc recalls Sterile custom surgical procedure packs: (1) 89-10507.02, TOTAL KNEE PACK, Stonewall Jackson Hospital; (2) 89-10508.
Hazard: The custom procedure packs contain light handle covers that have been recalled by another firm.
March 29, 2023Medical DevicesFDA
DeRoyal Industries Inc recalls DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000B
Hazard: The reason for the voluntary recall is due to shrinkage of the canister lid. This shrinkage causes the lid not to contact the outer shell to create a seal and thus, it does not create and hold vacuum.
January 18, 2023Medical DevicesFDA
DeRoyal Industries Inc recalls DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10
Hazard: DeRoyal is recalling certain lots of surgical procedure pack products that contain a Medtronic Non-Absorbable Suture. The recall is due to Medtronic determining a manufacturing error in the packaging of the non-absorbable sutures that may cause a gap or wrinkle in the breather seal resulting in a sterile barrier breach.
January 11, 2023Medical DevicesFDA
DeRoyal Industries Inc recalls DeRoyal Tonsillectomy Tray, REF 89-10698.01
Hazard: DeRoyal is recalling certain lots of surgical procedure pack products that contain a ConMed Foot Controlled Electrosurgical Suction Coagulator. The recall is due to ConMed receiving reports that the suction ports may be occluded on the affected devices. If this occurs, the affected devices will not be able to perform the suction function during use.
December 21, 2022Medical DevicesFDA
DeRoyal Industries Inc recalls DeRoyal CATARACT PACK, REF 89-10086.05
Hazard: DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
December 21, 2022Medical DevicesFDA
DeRoyal Industries Inc recalls DeRoyal CATARACT PACK, REF 89-10040.01
Hazard: XXX
December 21, 2022Medical DevicesFDA
DeRoyal Industries Inc recalls DeRoyal CATARACT PACK, REF 89-9241.04
Hazard: XXX
December 21, 2022Medical DevicesFDA
DeRoyal Industries Inc recalls DeRoyal CATARACT PACK, REF 89-9241.03
Hazard: XXX
December 21, 2022Medical DevicesFDA
DeRoyal Industries Inc recalls DeRoyal CATARACT PACK, REF 89-8859.08
Hazard: XXX
December 21, 2022Medical DevicesFDA
DeRoyal Industries Inc recalls DeRoyal CATARACT PACK, REF 89-8650.10
Hazard: XXX
December 21, 2022Medical DevicesFDA
DeRoyal Industries Inc recalls GEO-MED CATARACT PACK, REF 89-5790.08
Hazard: XXX
December 21, 2022Medical DevicesFDA
DeRoyal Industries Inc recalls DeRoyal TRACECART POSTEROR LAMI MICRODISC TRACECART, REF 53-1960.02
Hazard: XXX
December 21, 2022Medical DevicesFDA
DeRoyal Industries Inc recalls DeRoyal TRACECART POSTEROR LUMBAR FUSION TRACECART, REF 53-1961.02
Hazard: XXX
December 21, 2022Medical DevicesFDA
DeRoyal Industries Inc recalls DeRoyal TRACECART SHOULDER ARTHROSCOPY TRACECART, REF 53-1962.02
Hazard: XXX