DeRoyal Foot Pack Medical Device Recalled in Multiple States
DeRoyal Industries Inc voluntarily recalls 105 kits of DeRoyal Foot Pack (Lot 57899862, exp 3/1/2025) distributed across 23 U.S. states. Affected customers should contact the firm for recall instructions.
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: This is a voluntary Class II medical device recall initiated by the manufacturer with no reported injuries or illnesses documented in the source. Voluntary precautionary recalls without adverse events are typically scored as Moderate per the rubric.
Plain-English summary
DeRoyal Industries Inc is voluntarily recalling 105 kits of DeRoyal Foot Pack, model REF 89-9252.08 (Lot 57899862, expiration 3/1/2025). This is a Class II medical device recall initiated by the manufacturer on November 3, 2022.
The affected product was distributed across 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.
Customers and healthcare facilities who have received this product should contact DeRoyal Industries Inc immediately for recall instructions. Do not use the affected units until receiving guidance from the manufacturer. The recall status is ongoing as of December 21, 2022.
The recalled product
- Product
- DeRoyal FOOT PACK, REF 89-9252.08
- Manufacturer
- DeRoyal Industries Inc
- Category
- Medical Device
- Affected units
- 105
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 57899862 exp 3/1/2025
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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