The Recall Desk
ModerateFDA (Devices)·Z-0619-2023·Announced 2022-12-21

Medical Device Podiatry Kit Recalled by DeRoyal Industries

DeRoyal Industries is voluntarily recalling 76 GEO-MED PODIATRY PACK kits distributed across 23 U.S. states. The specific reason for this Class II recall is not detailed in the public notice.

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 voluntary, firm-initiated Class II medical device recall with no reported illnesses, injuries, or specified hazard information in the source material. Per FDA guidelines, Class II recalls without adverse event reports are classified as Moderate.

Plain-English summary

DeRoyal Industries Inc is conducting a voluntary Class II recall of the GEO-MED PODIATRY PACK PGYBK (REF 89-8700.01). The recall involves 76 kits distributed to medical facilities in Alabama, Arizona, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Tennessee, Texas, Virginia, Wisconsin, and Mississippi.

The specific reason for the recall is not provided in the publicly available notice. The affected products are identified by lot numbers 56618256 (expiring March 1, 2024) and 57005427 (expiring November 1, 2024).

If your facility has received this product, verify your inventory against the lot numbers provided. Contact DeRoyal Industries Inc at the manufacturer's address (200 Debusk Lane, Powell, Tennessee 37849-4703) for instructions on replacement or return of affected units.

The recalled product

Product
GEO-MED PODIATRY PACK PGYBK, REF 89-8700.01
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Surgical / Podiatry Supplies
Affected units
76

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 56618256 exp 3/1/2024
  • Lot 57005427 exp 11/1/2024

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 →

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