General Surgery Tray
Deroyal Industries, Inc.'s record for this product code
Recent MDR events
337 adverse event reports on file
- DEROYALApr 9, 2026Malfunction24828280
- CCASC LAPAROTOMY PACKDec 16, 2025Malfunction3005011024-2025-00016
- DEROYALDec 9, 2025Malfunction23756373
- SMALL GENERAL PACKDec 5, 2025Malfunction3005011024-2025-00015
- DEROYALNov 18, 2025Malfunction23582179
- CMC LAPAROTOMY PACKAug 25, 2025Malfunction3005011024-2025-00011
- CMC LAPAROSCOPY PACKAug 25, 2025Malfunction3005011024-2025-00013
- CMC VASCULAR PACKAug 25, 2025Malfunction3005011024-2025-00012
- DEROYALAug 20, 2025Malfunction22849296
- DEROYALAug 20, 2025Malfunction22849351
Recalls
203 recall events for this product code
- 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 ↗ - Open, ClassifiedJul 3, 2023
The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
View FDA record ↗ - Open, ClassifiedJun 7, 2023
The custom procedure packs contain light handle covers that have been recalled by another firm.
View FDA record ↗ - TerminatedJan 9, 2023
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.
View FDA record ↗ - TerminatedJan 5, 2023
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.
View FDA record ↗ - Open, ClassifiedDec 15, 2022
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
View FDA record ↗
510(k) clearances
1 clearances for this product code