Is this your brand? Sign in to claim ownership.
Sign in to claim this brandDEROYAL INDUSTRIES, INC.
United States·US-MF-000002102
Last updated September 17, 2026
What DEROYAL INDUSTRIES, INC. makes
DeRoyal Industries, Inc. manufactures single-use medical devices including general surgical procedure kits, hand/finger and arm immobilizers, cervical spine collars, and orthotic supports for the knee, lumbar spine, and ankle/foot. The company also produces angiography kits and non-medicated orthopedic splints designed for procedural and post-operative stabilization.
The portfolio includes devices classified as Class I, Class II, and unclassified (U) under FDA regulations, all listed in the FDA’s Unique Device Identification (UDI) database. The company is headquartered in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does DeRoyal Industries, Inc. manufacture?
DeRoyal Industries, Inc. specializes in single-use medical devices primarily focused on orthopedic stabilization and procedural support. Their portfolio includes general surgical procedure kits (non-medicated), hand/finger and arm immobilizers, cervical spine collars, knee/ankle/foot orthoses, lumbar spine orthoses, and angiography kits. These devices are designed for procedural use or post-operative stabilization without medication.
Where is DeRoyal Industries, Inc. based, and how does that affect its regulatory standing?
DeRoyal Industries, Inc. is headquartered in the United States. As a U.S.-based manufacturer, its devices are subject to FDA regulations, including classification under FDA’s device classification system (Class I, Class II, or unclassified). The company’s products are listed in the FDA’s Unique Device Identification (UDI) database, which helps track and regulate medical devices in the U.S. market.
Which regulatory registries or databases list DeRoyal Industries, Inc.’s devices?
DeRoyal Industries, Inc.’s devices are included in the FDA’s Unique Device Identification (UDI) database. This registry assigns a standardized identifier to each device, enabling traceability, reporting, and compliance tracking within the U.S. medical device regulatory framework. The UDI system is mandatory for most medical devices marketed in the U.S.
How are DeRoyal Industries, Inc.’s devices classified under FDA regulations?
DeRoyal’s devices fall into three classification categories under FDA regulations: Class I (generally low-risk, subject to general controls), Class II (moderate-risk, requiring special controls beyond general controls), and unclassified (U) devices, which may require further evaluation or specific regulatory pathways. Classification depends on factors like intended use, risk level, and procedural context, such as whether a device is used in surgery or post-operative care.
Why do some of DeRoyal’s devices appear as unclassified (U) in regulatory listings?
The unclassified (U) designation for some of DeRoyal’s devices indicates they have not yet been formally assigned a specific FDA classification (Class I or II) through the agency’s classification process. This can occur if the device is new, similar to existing unclassified devices, or if further data is needed to determine its risk level. Unclassified devices may require additional submissions or evidence to achieve a definitive classification before commercialization.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 200, DeBusk Ln, Powell, United States
- Website
- www.deroyal.com
- —
- —
- [email protected]
- Phone
- +1 865 362 1256
- PRRC Contact
- Elizabeth Reed
- EUDAMED SRN
- US-MF-000002102
- FDA FEI Number
- 1000208624
- DUNS Number
- 096372255
Catalogue (14021)
Page 28 of 281| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| DeRoyal | 89-5520 | FDA UDI | Class II | Active |
| DeRoyal | 23-314A-00 | FDA UDI | Class I | Active |
| DeRoyal | 89-9949 | FDA UDI | Class II | Active |
| DeRoyal | 11-001 | FDA UDI | Class I | Active |
| DeRoyal | RC-325MD | FDA UDI | Class I | Active |
| DeRoyal | 1001-04 | FDA UDI | Class I | Active |
| DeRoyal | 32-850 | FDA UDI | Class I | Active |
| DeRoyal | 13480056 | FDA UDI | Class I | Active |
| DeRoyal | 9106-05 | FDA UDI | Class I | Active |
| DeRoyal | 81-020412 | FDA UDI | Class II | Active |
| DeRoyal | 31-980 | FDA UDI | Class I | Active |
| DeRoyal | 89-8866 | FDA UDI | Class II | Active |
| DeRoyal | M190FF | FDA UDI | Class I | Active |
| DeRoyal | 405W11 | FDA UDI | Class I | Active |
| DeRoyal | M8138 | FDA UDI | Class I | Active |
| DeRoyal | 32-1496 | FDA UDI | Class I | Active |
| DeRoyal | 8824-10 | FDA UDI | Class I | Active |
| DeRoyal | 89-4832 | FDA UDI | Class II | Active |
| DeRoyal | 89-10125 | FDA UDI | Class II | Active |
| DeRoyal | 89-10013 | FDA UDI | Class II | Active |
| DeRoyal | 11-428A-03 | FDA UDI | Class I | Active |
| DeRoyal | 11483000 | FDA UDI | Class I | Active |
| DeRoyal | 89-7490 | FDA UDI | Class II | Active |
| DeRoyal | T5036ST-L | FDA UDI | Class II | Active |
| DeRoyal | 89-8992 | FDA UDI | Class II | Active |
| DeRoyal | 32-674 | FDA UDI | Class I | Active |
| DeRoyal | 10-8152 | FDA UDI | Class I | Active |
| DeRoyal | M10-093 | FDA UDI | Class I | Active |
| DeRoyal | U101 | FDA UDI | Class II | Active |
| DeRoyal | 89-10063 | FDA UDI | Class II | Active |
| DeRoyal | OPB3533-S | FDA UDI | Class I | Active |
| DeRoyal | 4270AA | FDA UDI | Class I | Active |
| DeRoyal | 10-7421 | FDA UDI | Class I | Active |
| DeRoyal | 301743 | FDA UDI | Class II | Active |
| DeRoyal | 89-9184 | FDA UDI | Class II | Active |
| DeRoyal | 89-7354 | FDA UDI | Class II | Active |
| DeRoyal | 89-7088 | FDA UDI | Class II | Active |
| DeRoyal | SI5-R | FDA UDI | Class II | Active |
| DeRoyal | 89-11054 | FDA UDI | Class II | Active |
| DeRoyal | 89-10107 | FDA UDI | Class II | Active |
| DeRoyal | 46-GZ44 | FDA UDI | U | Active |
| DeRoyal | 63-001-400 | FDA UDI | Class II | Active |
| DeRoyal | 11630007-HPG | FDA UDI | Class I | Active |
| DeRoyal | 406N26 | FDA UDI | Class I | Active |
| DeRoyal | 11-441A-06 | FDA UDI | Class I | Active |
| DeRoyal | HD-395-1000 | FDA UDI | Class I | Active |
| DeRoyal | 89-10769 | FDA UDI | Class II | Active |
| DeRoyal | 1005-05 | FDA UDI | Class I | Active |
| DeRoyal | 81-090401 | FDA UDI | Class II | Active |
| DeRoyal | 89-9342 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (100)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
DeRoyal Industries, Inc. has 236 recall records initiated between February 14, 2003, and May 18, 2026, with statuses recorded as open, classified, or terminated. The reasons cited include issues with sterile packaging and syringe integrity (e.g., damaged luer tips compromising barrier seals), malfunctioning or unintended activation of medical devices (e.g., smoke evacuation pencils activating without manual input), and failures in sterility assurance due to packaging defects. Additional recalls involved mislabeled or incorrectly sized medical tubes, non-sterile surgical blades, and components distributed as part of previously recalled kits or devices. Some recalls were initiated due to physical failures, such as tearing of specimen retrieval bags or improper sealing of canister lids.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| May 18, 2026 | Z-2305-2026 | — | open, classified | Sterile wound dressing, lacks sterility assurance |
| Jan 31, 2025 | Z-1291-2025 | — | open, classified | 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. |
| Jan 15, 2025 | Z-1174-2025 | — | open, classified | 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. |
| Oct 3, 2024 | Z-0307-2025 | — | open, classified | 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. |
| Oct 3, 2024 | Z-0308-2025 | — | open, classified | 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. |
| Oct 3, 2024 | Z-0309-2025 | — | open, classified | 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. |
| Oct 3, 2024 | Z-0306-2025 | — | open, classified | 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. |
| Feb 13, 2024 | Z-1382-2024 | — | open, classified | DeRoyal manufactured and distributed Surgical Tracecarts that contain a Nurse Assist 16FR Silver Urine Meter Foley which were subsequently recalled. |
| Nov 22, 2023 | Z-0622-2024 | — | open, classified | Kit were manufactured and distributed with Edwards Life Sciences TruWave Disposable pressure transducers which were subsequently recalled by Edwards Life Sciences. |
| Sep 18, 2023 | Z-0116-2024 | — | open, classified | 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. |
| May 30, 2023 | Z-2087-2023 | — | open, classified | The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside. |
| May 30, 2023 | Z-2090-2023 | — | open, classified | The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside. |
| May 30, 2023 | Z-2089-2023 | — | open, classified | The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside. |
| May 30, 2023 | Z-2086-2023 | — | open, classified | The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside. |
| May 30, 2023 | Z-2088-2023 | — | open, classified | The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside. |
| Apr 17, 2023 | Z-1692-2023 | — | open, classified | The custom procedure packs contain light handle covers that have been recalled by another firm. |
| Apr 17, 2023 | Z-1691-2023 | — | open, classified | The custom procedure packs contain light handle covers that have been recalled by another firm. |
| Feb 9, 2023 | Z-1283-2023 | — | open, classified | 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. |
| Dec 12, 2022 | Z-0927-2023 | — | open, classified | 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. |
| Nov 28, 2022 | Z-0906-2023 | — | terminated | 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. |
| Nov 3, 2022 | Z-0695-2023 | — | open, classified | XXX |
| Nov 3, 2022 | Z-0591-2023 | — | open, classified | DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. |
| Nov 3, 2022 | Z-0681-2023 | — | open, classified | XXX |
| Nov 3, 2022 | Z-0573-2023 | — | open, classified | DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. |
| Nov 3, 2022 | Z-0638-2023 | — | open, classified | XXX |
| Nov 3, 2022 | Z-0711-2023 | — | open, classified | XXX |
| Nov 3, 2022 | Z-0621-2023 | — | open, classified | XXX |
| Nov 3, 2022 | Z-0569-2023 | — | open, classified | DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. |
| Nov 3, 2022 | Z-0683-2023 | — | open, classified | XXX |
| Nov 3, 2022 | Z-0682-2023 | — | open, classified | XXX |
| Nov 3, 2022 | Z-0698-2023 | — | open, classified | XXX |
| Nov 3, 2022 | Z-0598-2023 | — | open, classified | DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. |
| Nov 3, 2022 | Z-0668-2023 | — | open, classified | XXX |
| Nov 3, 2022 | Z-0649-2023 | — | open, classified | XXX |
| Nov 3, 2022 | Z-0634-2023 | — | open, classified | XXX |
| Nov 3, 2022 | Z-0584-2023 | — | open, classified | XXX |
| Nov 3, 2022 | Z-0599-2023 | — | open, classified | XXX |
| Nov 3, 2022 | Z-0709-2023 | — | open, classified | XXX |
| Nov 3, 2022 | Z-0576-2023 | — | open, classified | XXX |
| Nov 3, 2022 | Z-0562-2023 | — | open, classified | DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. |
| Nov 3, 2022 | Z-0646-2023 | — | open, classified | XXX |
| Nov 3, 2022 | Z-0601-2023 | — | open, classified | XXX |
| Nov 3, 2022 | Z-0635-2023 | — | open, classified | XXX |
| Nov 3, 2022 | Z-0577-2023 | — | open, classified | XXX |
| Nov 3, 2022 | Z-0697-2023 | — | open, classified | XXX |
| Nov 3, 2022 | Z-0680-2023 | — | open, classified | XXX |
| Nov 3, 2022 | Z-0652-2023 | — | open, classified | XXX |
| Nov 3, 2022 | Z-0665-2023 | — | open, classified | XXX |
| Nov 3, 2022 | Z-0574-2023 | — | open, classified | XXX |
| Nov 3, 2022 | Z-0571-2023 | — | open, classified | DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. |
| Nov 3, 2022 | Z-0688-2023 | — | open, classified | XXX |
| Nov 3, 2022 | Z-0619-2023 | — | open, classified | XXX |
| Nov 3, 2022 | Z-0572-2023 | — | open, classified | DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. |
| Nov 3, 2022 | Z-0602-2023 | — | open, classified | DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. |
| Nov 3, 2022 | Z-0678-2023 | — | open, classified | XXX |
| Nov 3, 2022 | Z-0701-2023 | — | open, classified | XXX |
| Nov 3, 2022 | Z-0567-2023 | — | open, classified | DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. |
| Nov 3, 2022 | Z-0714-2023 | — | open, classified | XXX |
| Nov 3, 2022 | Z-0642-2023 | — | open, classified | XXX |
| Nov 3, 2022 | Z-0641-2023 | — | open, classified | XXX |
| Nov 3, 2022 | Z-0581-2023 | — | open, classified | DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. |
| Nov 3, 2022 | Z-0647-2023 | — | open, classified | XXX |
| Nov 3, 2022 | Z-0631-2023 | — | open, classified | XXX |
| Nov 3, 2022 | Z-0713-2023 | — | open, classified | XXX |
| Nov 3, 2022 | Z-0592-2023 | — | open, classified | DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. |
| Nov 3, 2022 | Z-0608-2023 | — | open, classified | XXX |
| Nov 3, 2022 | Z-0564-2023 | — | open, classified | DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. |
| Nov 3, 2022 | Z-0651-2023 | — | open, classified | XXX |
| Nov 3, 2022 | Z-0614-2023 | — | open, classified | DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. |
| Nov 3, 2022 | Z-0616-2023 | — | open, classified | DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. |
| Nov 3, 2022 | Z-0699-2023 | — | open, classified | XXX |
| Nov 3, 2022 | Z-0632-2023 | — | open, classified | XXX |
| Nov 3, 2022 | Z-0700-2023 | — | open, classified | XXX |
| Nov 3, 2022 | Z-0612-2023 | — | open, classified | XXX |
| Nov 3, 2022 | Z-0626-2023 | — | open, classified | DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. |
| Nov 3, 2022 | Z-0706-2023 | — | open, classified | XXX |
| Nov 3, 2022 | Z-0661-2023 | — | open, classified | XXX |
| Nov 3, 2022 | Z-0710-2023 | — | open, classified | XXX |
| Nov 3, 2022 | Z-0590-2023 | — | open, classified | DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. |
| Nov 3, 2022 | Z-0659-2023 | — | open, classified | XXX |
| Nov 3, 2022 | Z-0658-2023 | — | open, classified | XXX |
| Nov 3, 2022 | Z-0579-2023 | — | open, classified | XXX |
| Nov 3, 2022 | Z-0660-2023 | — | open, classified | XXX |
| Nov 3, 2022 | Z-0589-2023 | — | open, classified | XXX |
| Nov 3, 2022 | Z-0611-2023 | — | open, classified | XXX |
| Nov 3, 2022 | Z-0663-2023 | — | open, classified | XXX |
| Nov 3, 2022 | Z-0578-2023 | — | open, classified | XXX |
| Nov 3, 2022 | Z-0712-2023 | — | open, classified | XXX |
| Nov 3, 2022 | Z-0690-2023 | — | open, classified | XXX |
| Nov 3, 2022 | Z-0657-2023 | — | open, classified | XXX |
| Nov 3, 2022 | Z-0667-2023 | — | open, classified | XXX |
| Nov 3, 2022 | Z-0607-2023 | — | open, classified | XXX |
| Nov 3, 2022 | Z-0643-2023 | — | open, classified | XXX |
| Nov 3, 2022 | Z-0630-2023 | — | open, classified | XXX |
| Nov 3, 2022 | Z-0636-2023 | — | open, classified | XXX |
| Nov 3, 2022 | Z-0580-2023 | — | open, classified | DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. |
| Nov 3, 2022 | Z-0670-2023 | — | open, classified | XXX |
| Nov 3, 2022 | Z-0669-2023 | — | open, classified | XXX |
| Nov 3, 2022 | Z-0563-2023 | — | open, classified | DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. |
| Nov 3, 2022 | Z-0672-2023 | — | open, classified | XXX |