FDA Recalls Medical Device: DeRoyal EMERGENT Trauma Pack
DeRoyal Industries initiated a voluntary recall of the DeRoyal EMERGENT TRAUMA PACK (6 kits). The recall affects units distributed across 23 U.S. states.
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: This is an FDA Class II medical device recall with no reported illnesses or injuries. The recall is voluntary and manufacturer-initiated. The specific reason or hazard is not disclosed in source materials.
Plain-English summary
DeRoyal Industries Inc. is recalling the DeRoyal EMERGENT TRAUMA PACK, Reference 89-9453.13. The recall involves 6 kits with Lot Number 57199372, which expire on June 1, 2025.
The specific reason for this recall has not been disclosed in available recall notices. This is a voluntary recall initiated by the manufacturer.
The affected products were distributed across 23 U.S. 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.
If you have purchased or received this product, contact DeRoyal Industries Inc. for further guidance regarding the recall.
The recalled product
- Product
- DeRoyal EMERGENT TRAUMA PACK, REF 89-9453.13
- Manufacturer
- DeRoyal Industries Inc
- Affected units
- 6
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 57199372 exp 6/1/2025
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.
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