The Recall Desk
HighFDA (Devices)·Z-0638-2023·Announced 2022-12-21

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.

What this means for you

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
Category
Medical Device — Foot Care Equipment
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

Distributed in 23 states:

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.

See all 156 products in this recall →

Related recalls

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