DeRoyal Industries Inc
17 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for DeRoyal Industries Inc and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-03-12FDA-DeviceClass IIDeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF 71-C6100NS Tubing, Suction, Connector; DeRoyal REF 71-C7100NS Tubing, Suction, Connector Indicated use - Fluid Movement
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.
- 2025-02-26FDA-DeviceClass IIDeRoyal AMG Suction Connector Tubing REF: 71-2083, 71-C506, 71-C510, 71-C512, 71-C520, Tubing is intended for fluid movement
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.
- 2024-11-13FDA-DeviceClass IIDeRoyal CHILDREN'S LAPTRACEPACK, 89-9362.06
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.
- 2024-11-13FDA-DeviceClass IIDeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06
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.
- 2024-11-13FDA-DeviceClass IIDeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-06
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.
- 2024-11-13FDA-DeviceClass IIDeRoyal C-SECTION TRACEPACK, REF 89-9338-06
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.
- 2024-04-03FDA-DeviceClass IGeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECART, b) 53-1836 GENERAL SURGERY TRACECART
DeRoyal manufactured and distributed Surgical Tracecarts that contain a Nurse Assist 16FR Silver Urine Meter Foley which were subsequently recalled.
- 2024-01-03FDA-DeviceClass IIDeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572
Kit were manufactured and distributed with Edwards Life Sciences TruWave Disposable pressure transducers which were subsequently recalled by Edwards Life Sciences.
- 2023-10-25FDA-DeviceClass IIDeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit
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.
- 2023-07-12FDA-DeviceClass IICustom medical procedure packs labeled as: a) CATH ANGIOGRAPHY DRAPE PACK, REF 89-7102; b) CHOLANGIOGRAPHY KIT, REF 89-7322; c) CATH LAB PACK, REF 89-9183
The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
- 2023-07-12FDA-DeviceClass IICustom medical procedure packs labeled as: a) PELVIC EXAM TRAY, REF 89-6219
The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
- 2023-07-12FDA-DeviceClass IICustom medical procedure packs labeled as: a) STANDARD OB PACK ASCENSION WI, REF 89-10640 b) ANGIO PACK, REF 89-10901 c) BASIN, REF 89-1924 d) CYSTO PACK, REF 89-7133 e) TOTAL HIP PACK, REF 89-9134 f) EMERGENCY C-SECTION PACK, REF 89-9478
The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
- 2023-07-12FDA-DeviceClass IICustom medical procedure packs labeled as: a) STURDI STRAINER TRAY STANDARD, REF '89-5014
The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
- 2023-07-12FDA-DeviceClass IICustom medical procedure packs labeled as: a) OPEN HEART TRACECART, REF '53-1941; b) CARDIAC CATH PACK, REF '89-10045; c) SHOULDER PACK, REF '89-10115; d) MINOR ORTHO PACK, REF '89-10213; e) TOTAL KNEE PACK PGYBK, REF '89-10505; f) ANTERIOR HIP PACK PGYBK, REF '89-10563; g) ORTHO X-RAY PACK, REF '89-1495; h) GU PACK, REF '89-4479; i) BREAST PACK, REF '89-5424; j) SHOULDER ARTHROSCOPY PK, REF '89-6606; k) GYN PACK, REF '89-7369; l) ENT PACK, REF '89-7378; m) TOTAL HI
The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
- 2023-06-14FDA-DeviceClass IISterile custom surgical procedure packs (1) 89-10529.04, CNRV OR C-SECTION PACK, New River Valley Medical Center; and (2) 89-10567.05, OB-OR C-SECTION PACK, Carilion Roanoke Memorial Hospital.
The custom procedure packs contain light handle covers that have been recalled by another firm.
- 2023-06-14FDA-DeviceClass IISterile custom surgical procedure packs: (1) 89-10507.02, TOTAL KNEE PACK, Stonewall Jackson Hospital; (2) 89-10508.02, LOCAL PACK, Stonewall Jackson Hospital; (3) 89-10509.02, LAPAROTOMY PACK, Stonewall Jackson Hospital; (4) 89-10517.04, CNRV BASIC SETUP PACK, New River Valley Medical Center; (5) 89-10526.04, CNRV LAPAROSCOPY PACK, New River Valley Medical Center; (6) 89-10530.04, CNRV PERIPHERAL VAS PACK, New River Valley Medical Center; (7) 89-10532.04, CNRV SPINE PACK, New River Val
The custom procedure packs contain light handle covers that have been recalled by another firm.
- 2023-03-29FDA-DeviceClass IIDeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000B
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.
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