DeRoyal Hand Pack Medical Device Recall Class II
DeRoyal Industries initiated a voluntary recall of 18 DeRoyal Hand Pack medical device kits (Lot 56615021) distributed across 23 U.S. states. The specific reason for the recall is not provided in the available source material.
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: Class II medical device recall initiated voluntarily by the manufacturer. No reported illnesses, injuries, or hospitalizations are documented in the source material. This aligns with the rubric category of 'voluntary precautionary recalls' classified as Moderate severity.
Plain-English summary
DeRoyal Industries Inc. is recalling the DeRoyal Hand Pack (product reference 89-10314.02). The recall affects 18 kits bearing lot number 56615021, which expire on June 1, 2026. This is a voluntary, Class II medical device recall initiated by the manufacturer.
The affected kits were distributed to medical facilities and healthcare providers in 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.
The specific reason for this recall is not provided in the available FDA source material. No illnesses or injuries have been reported in connection with this recall. As of the most recent update, the recall status remains ongoing.
The recalled product
- Product
- DeRoyal HAND PACK, REF 89-10314.02
- Manufacturer
- DeRoyal Industries Inc
- Category
- Medical Device
- 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 56615021 exp 6/1/2026
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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