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Sign in to claim this brandDEROYAL INDUSTRIES, INC.
United States·US-MF-000002102
Last updated September 17, 2026
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 2 of 281| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| DeRoyal | 89-5686 | FDA UDI | Class II | Active |
| DeRoyal | EU4020-U4 | FDA UDI | Class I | Active |
| DeRoyal | 89-2117 | FDA UDI | Class II | Active |
| DeRoyal | 46-IV25B | FDA UDI | U | Active |
| DeRoyal | 32-1694 | FDA UDI | Class I | Active |
| DeRoyal | 72-3125 | FDA UDI | Class II | Active |
| DeRoyal | T5030NS-10 | FDA UDI | Class II | Active |
| DeRoyal | A125205 | FDA UDI | Class I | Active |
| DeRoyal | 89-10855 | FDA UDI | Class II | Active |
| DeRoyal | 89-2800 | FDA UDI | Class II | Active |
| DeRoyal | 14612010 | FDA UDI | Class I | Active |
| DeRoyal | 9111-06 | FDA UDI | Class I | Active |
| DeRoyal | MTS33-15-H | FDA UDI | Class I | Active |
| DeRoyal | 77-400376 | FDA UDI | Class II | Active |
| DeRoyal | 14582006 | FDA UDI | Class I | Active |
| DeRoyal | BS1000-50 | FDA UDI | Class I | Active |
| DeRoyal | 640 | FDA UDI | Class I | Active |
| DeRoyal | 9844-43 | FDA UDI | Class I | Active |
| DeRoyal | 89-9140 | FDA UDI | Class II | Active |
| DeRoyal | 89-7671 | FDA UDI | Class II | Active |
| DeRoyal | 89-8562 | FDA UDI | Class II | Active |
| DeRoyal | 1-524A-04-CFSM | FDA UDI | Class I | Active |
| DeRoyal | 46-371 | FDA UDI | Class I | Active |
| DeRoyal | 89-7370 | FDA UDI | Class II | Active |
| DeRoyal | 23-324A-05 | FDA UDI | Class I | Active |
| DeRoyal | 25-0501NS | FDA UDI | Class I | Active |
| DeRoyal | 11-442A-02 | FDA UDI | Class I | Active |
| DeRoyal | 11-439A-06 | FDA UDI | Class I | Active |
| DeRoyal | 348XSL | FDA UDI | Class I | Active |
| DeRoyal | 89-6352 | FDA UDI | Class II | Active |
| DeRoyal | 89-3655 | FDA UDI | Class II | Active |
| DeRoyal | 89-10238 | FDA UDI | Class II | Active |
| DeRoyal | TX9903-02 | FDA UDI | Class I | Active |
| DeRoyal | 89-11092 | FDA UDI | Class II | Active |
| DeRoyal | 89-10808 | FDA UDI | Class II | Active |
| DeRoyal | 88-000703 | FDA UDI | Class II | Active |
| DeRoyal | 400W74 | FDA UDI | Class I | Active |
| DeRoyal | 46-325X | FDA UDI | Class I | Active |
| DeRoyal | 89-10282 | FDA UDI | Class II | Active |
| DeRoyal | 89-9091 | FDA UDI | Class I | Active |
| DeRoyal | 89-7518 | FDA UDI | Class I | Active |
| DeRoyal | 9999-28 | FDA UDI | Class I | Active |
| DeRoyal | 13790307 | FDA UDI | Class I | Active |
| DeRoyal | 23-007 | FDA UDI | Class I | Active |
| DeRoyal | 7047-04 | FDA UDI | Class I | Active |
| DeRoyal | 63-2221 | FDA UDI | Class II | Active |
| DeRoyal | 89-10625 | FDA UDI | Class I | Active |
| DeRoyal | 89-8883 | FDA UDI | Class II | Active |
| DeRoyal | 89-9163 | FDA UDI | Class I | Active |
| DeRoyal | 89-8249 | 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.
| 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 |