FDA Class II: DeRoyal Trauma Pack Voluntary Recall
DeRoyal Industries initiated a voluntary recall of EMERGENT TRAUMA PACK kits (18 units) distributed to hospitals and medical facilities across 23 US states. The specific reason for the recall was not disclosed in the FDA notification.
What this means for you
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 a voluntary, FDA Class II medical device recall with no reported illnesses or injuries. The specific hazard or reason for the recall was not disclosed in the source material, and no hospitalization or adverse event reports are documented. Per the severity rubric, voluntary recalls without reported harm are classified as Moderate.
Plain-English summary
DeRoyal Industries Inc recalled the EMERGENT TRAUMA PACK, reference number 89-9453.12, affecting 18 kits distributed to medical facilities. Two lot numbers are involved: Lot 55969791 (expiration 5/1/2024) and Lot 56755349 (expiration 6/1/2025).
The specific hazard or defect prompting the recall was not disclosed in the FDA's recall notice. This Class II recall was initiated voluntarily by the manufacturer on November 3, 2022, with FDA classification finalized on December 15, 2022.
The affected products were distributed across 23 US states: Alabama, Arizona, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Tennessee, Texas, Virginia, and Wisconsin.
Healthcare facilities or individuals with affected units should contact DeRoyal Industries Inc directly for instructions regarding the recalled product.
The recalled product
- Product
- DeRoyal EMERGENT TRAUMA PACK, ref 89-9453.12
- Manufacturer
- DeRoyal Industries Inc
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 (2)
- Lot Numbers: Lot 55969791 exp 5/1/2024
- Lot 56755349 exp 6/1/2025
Distribution
Distribution scope not specified by the agency.
Related recalls
Same category
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- SevereAbiomed Automated Impella Controller recalled for motor control and pump failure risks
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03