Medical Device Recall: DeRoyal Podiatry Pack, Class II
DeRoyal Industries Inc voluntarily recalled 102 kits of its podiatry pack (Lot 57593741, exp. 1/1/2027). The recall affects 22 US states; the specific reason is not detailed in available source material.
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 Class II FDA medical device recall initiated voluntarily by the manufacturer. No illnesses, injuries, hospitalizations, or specific hazards are documented in the source material, consistent with a precautionary or voluntary recall.
Plain-English summary
DeRoyal Industries Inc issued a voluntary, firm-initiated recall of 102 kits of the DeRoyal PODIATRY PACK, REF 89-8359.13. The recall was initiated on November 3, 2022, and remains ongoing.
The affected lot is Lot 57593741, with an expiration date of January 1, 2027. This Class II recall impacts healthcare facilities and providers in 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, and Georgia.
The specific reason for the recall is not provided in the available source material. Healthcare facilities or individuals possessing units from the affected lot should refer to official FDA documentation or contact DeRoyal Industries Inc directly for guidance on handling, inspection, or return procedures.
For additional information, contact DeRoyal Industries Inc at 200 Debusk Ln, Powell, TN 37849-4703, or consult the official FDA recall notice (Z-0612-2023).
The recalled product
- Product
- DeRoyal PODIATRY PACK, REF 89-8359.13
- 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 57593741 exp 1/1/2027
Distribution
Distribution scope not specified by the agency.
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