FDA Class II Medical Device Recall: DeRoyal Extremity Pack Kits
DeRoyal extremity pack kits are subject to a voluntary FDA Class II recall. Three production lots distributed across 23 states are affected.
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 an FDA Class II medical device recall initiated voluntarily by the manufacturer. No illnesses, injuries, or adverse health consequences are reported in the source. Per the rubric, a voluntary precautionary Class II recall without reported harm scores as Moderate.
Plain-English summary
DeRoyal Industries Inc initiated a voluntary recall of DeRoyal KIT EXTREMITY PACK, REF 89-8869.09. The recall affects 75 kits across three production lots: Lot 56390950 (expiration 6/1/2026), Lot 56837871 (expiration 9/1/2026), and Lot 5718781 (expiration 10/1/2026).
The affected kits were distributed across 23 US states including 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 FDA classified this as a Class II recall. The specific reason for the recall was not disclosed in the public notice. Consumers or healthcare facilities in possession of affected lots should contact DeRoyal Industries Inc for guidance on the recall.
The recalled product
- Product
- DeRoyal KIT EXTREMITY PACK, REF 89-8869.09
- Manufacturer
- DeRoyal Industries Inc
- Category
- Medical Device — Surgical Kit
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 (3)
- Lot Numbers: Lot 56390950 exp 6/1/2026
- Lot 56837871 exp 9/1/2026
- Lot 5718781 exp 10/1/2026
Distribution
Distribution scope not specified by the agency.
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