FDA Class II recall of DeRoyal FOOT PACK medical devices
DeRoyal Industries Inc has recalled 350 kits of the DeRoyal FOOT PACK medical device in a Class II FDA recall. The specific reason for the recall was not publicly disclosed in available agency records.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall with no reported illnesses, injuries, or deaths documented in the source material and no specified hazard. Per the rubric, Class II recalls without reported harm are scored at a maximum of 3.
Plain-English summary
DeRoyal Industries Inc initiated a voluntary Class II recall on November 3, 2022, for 350 kits of the DeRoyal FOOT PACK (Reference 89-9252.06), a medical device.
The specific reason for this recall is not provided in the available agency documentation.
The recall affects two lot numbers: Lot 56005476 (expiring 8/1/2024) and Lot 56389449 (expiring 1/1/2025). These products were distributed to 22 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.
Individuals and healthcare facilities who have received this product should contact DeRoyal Industries Inc for recall instructions and guidance on appropriate next steps.
The recalled product
- Product
- DeRoyal FOOT PACK, REF 89-9252.06
- Manufacturer
- DeRoyal Industries Inc
- Affected units
- 350
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 (2)
- Lot Numbers: Lot 56005476 exp 8/1/2024
- Lot 56389449 exp 1/1/2025
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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