Deroyal Industries, Inc.
1703 Highway 33 S, NEW TAZEWELL, TN, US
Registered product codes
134 product codes
Recent MDR events
1,177 on file
- Incision Mgmt Convenience Kit, Prospera Flex®/Lumitech20Jul 30, 2026Malfunction2320762-2026-00012
- Incision Mgmt Convenience Kit, Prospera Flex®/Lumitech20Jul 30, 2026Malfunction2320762-2026-00013
- Incision Mgmt Convenience Kit, Prospera Flex®/Lumitech20Jul 30, 2026Malfunction2320762-2026-00014
- Algidex Ag®+ I.V. Dressing, 1" (3 cm) Disc, 4 mm openingJul 30, 2026Injury2320762-2026-00015
- NPWT Unity Large MAXX Kit, Black Foam KitJul 29, 2026Injury2320762-2026-00011
- FOLEY CATHETER, 400 SERIES 8 FRJul 29, 2026Malfunction2320762-2026-00010
- DEROYALJul 22, 2026Malfunction25904502
- UMBILICUPJul 13, 2026MalfunctionMW5190626
- DEROYALJun 30, 2026Malfunction25664746
- #11 SAFETY SCALPEL, NS, #11 NEW DESIGN, BULK, NSJun 25, 2026Malfunction1123071-2026-00001
Recalls
258 on file
- Open, ClassifiedJun 3, 2026
Sterile wound dressing, lacks sterility assurance
View FDA record ↗ - Open, ClassifiedMar 5, 2025
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.
View FDA record ↗ - Open, ClassifiedFeb 14, 2025
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.
View FDA record ↗ - Open, ClassifiedNov 5, 2024
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.
View FDA record ↗ - Open, ClassifiedNov 5, 2024
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.
View FDA record ↗ - Open, ClassifiedNov 5, 2024
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.
View FDA record ↗ - Open, ClassifiedNov 5, 2024
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.
View FDA record ↗ - Open, ClassifiedSep 30, 2024
Kit were manufactured and distributed with Edwards Life Sciences TruWave Disposable pressure transducers which were subsequently recalled by Edwards Life Sciences.
View FDA record ↗ - Open, ClassifiedMar 29, 2024
DeRoyal manufactured and distributed Surgical Tracecarts that contain a Nurse Assist 16FR Silver Urine Meter Foley which were subsequently recalled.
View FDA record ↗ - Open, ClassifiedOct 16, 2023
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.
View FDA record ↗
Compliance history
Matched by FEI 1000208624.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.