FDA Class II Recall of DeRoyal Cannulated Hip Pack Medical Devices
DeRoyal Industries has initiated a voluntary recall of 36 kits of DeRoyal Cannulated Hip Pack medical devices distributed across 23 US states. No injuries or illnesses have been reported.
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, firm-initiated FDA Class II medical device recall with no reported injuries or illnesses and no publicly disclosed reason. The absence of reported adverse events and the precautionary nature of the recall are consistent with FDA Class II guidance, placing this in the Moderate category.
Plain-English summary
DeRoyal Industries Inc has recalled 36 kits of the DeRoyal Cannulated Hip Pack (Reference 89-6977.10) in a voluntary, firm-initiated recall classified by the FDA as Class II. The affected product is Lot 57198177 with an expiration date of April 1, 2025.
The specific reason for this recall has not been publicly disclosed in the available source documentation.
The recalled product was distributed across 23 US 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 manufacturer, DeRoyal Industries Inc, is headquartered in Powell, Tennessee.
No injuries or illnesses have been reported in connection with this recall. Customers who have received the affected product should contact DeRoyal Industries Inc for instructions regarding the recalled item.
The recalled product
- Product
- DeRoyal CANNULTED HIP PACK, REF 89-6977.10
- Manufacturer
- DeRoyal Industries Inc
- Category
- Medical Device — Surgical Supply
- Hazard
- undisclosed-defect
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 57198177 exp 4/1/2025
Distribution
Distribution scope not specified by the agency.
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