The Recall Desk
ModerateFDA (Devices)·Z-0611-2023·Announced 2022-12-21

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
Category
Medical Device — Surgical Kit / Podiatry
Affected units
186

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

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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