Medical Device Recall: DeRoyal Podiatry Pack Kit (FDA Class II)
DeRoyal Industries has initiated a voluntary recall of 186 DeRoyal Podiatry Pack kits (Lot 56705544, exp. 6/1/2026) distributed across 22 US states. The specific reason is not provided in the source documentation.
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: FDA Class II recall with no reported illnesses, injuries, or documented serious hazards. The recall is voluntary and firm-initiated, consistent with Moderate severity for Class II recalls without evidence of harm.
Plain-English summary
DeRoyal Industries Inc. is recalling 186 kits of the DeRoyal PODIATRY PACK (REF 89-8359.10) through a voluntary, firm-initiated recall classified as Class II by the FDA.
The specific reason for this recall is not documented in the available source material. The affected lot (Lot 56705544) expires June 1, 2026 and was distributed across 22 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.
Healthcare facilities and individuals who received this product should verify their inventory for the specified lot number and expiration date. Contact DeRoyal Industries Inc. for recall-specific instructions and remediation guidance.
The recalled product
- Product
- DeRoyal PODIATRY PACK, REF 89-8359.10
- 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 (1)
- Lot Numbers: Lot 56705544 exp 6/1/2026
Distribution
Distribution scope not specified by the agency.
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