DeRoyal EMERGENT TRAUMA PACK recall affects 18 kits across 23 states
DeRoyal is recalling 18 EMERGENT TRAUMA PACK units distributed to 23 states. The specific reason for recall is not documented in available source materials.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Classified as FDA Class II, but the specific hazard is not documented in the source material. No illnesses or injuries are reported. Without articulation of the specific risk, a Moderate rating reflects the incomplete hazard information available.
Plain-English summary
DeRoyal Industries Inc is voluntarily recalling 18 units of the EMERGENT TRAUMA PACK, REF 89-9453.14. The recall involves Lot Number 57754971 (expiration date 1/1/2025) and affects distribution across 23 states: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, and Mississippi.
The detailed reason for this recall is not specified in the available FDA documentation. This is an ongoing, voluntary recall initiated by the manufacturer on November 3, 2022, and classified as FDA Class II.
Healthcare facilities and individuals who may have received this product should contact DeRoyal Industries Inc for guidance on this recall and any necessary actions regarding the affected units.
The recalled product
- Product
- DeRoyal EMERGENT TRAUMA PACK, REF 89-9453.14
- Manufacturer
- DeRoyal Industries Inc
- Affected units
- 18
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Numbers: Lot 57754971 exp 1/1/2025
Distribution
Part of a larger recall action
This product is one of 156 recalled by DeRoyal Industries Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 156 products in this recall →Related recalls
Same manufacturer · DeRoyal Industries Inc
See all →- ModerateDeRoyal Myocardial Probe Recall Due to Incorrect Needle Length
FDA (Devices) · 2026-09-30
- ModerateVascular Access Dressing Recalled Due to Lack of Sterility Assurance
FDA (Devices) · 2026-06-10
- HighDeRoyal Suction Connector Tubing Recalled for Assembly and Function Issues
FDA (Devices) · 2025-03-12
- HighDeRoyal AMG Suction Connector Tubing connection may fail to seal
FDA (Devices) · 2025-02-26
- HighDeRoyal Children's Orthopedic Tracepack Smoke Evacuation Pencil Malfunction Recall
FDA (Devices) · 2024-11-13
Similar recalls
- HighDeRoyal Children's Orthopedic Tracepack Smoke Evacuation Pencil Malfunction Recall
FDA (Devices) · 2024-11-13
- ModerateDeRoyal Heart Tracecart Recall Due to Contained Chest Drainage Product Issue
FDA (Devices) · 2017-03-01
- ModerateDeRoyal Heart Tracecart Recall Due to Sterile Component Packaging Issue
FDA (Devices) · 2017-03-01
- HighDeRoyal Children's Surgical Pack Recalled for Smoke Pencil Malfunction
FDA (Devices) · 2024-11-13
- ModerateDeRoyal Recalls Surgical Kits Due to Missing Protective Tape
FDA (Devices) · 2012-07-25
- ModerateDeRoyal Sterile Custom Kits Recalled for Defective Connectors
FDA (Devices) · 2022-09-07