The Recall Desk
ModerateFDA (Devices)·Z-0570-2023·Announced 2022-12-21

GEO-MED Podiatry Pack Recalled Due to Previously Recalled Component

DeRoyal Industries is recalling 184 GEO-MED PODIATRY PACK kits distributed across 23 U.S. states because they contain 3M Health Care Steri Drapes that were previously recalled. The affected kits have specific lot numbers with expirations through February 2025.

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 classification with no reported illnesses, injuries, or deaths in the source. This is a precautionary, containment-type recall addressing the presence of a previously recalled component within the procedure kit.

Plain-English summary

DeRoyal Industries Inc is recalling the GEO-MED PODIATRY PACK PGYBK (Reference 89-6240.05), a medical device kit used in podiatry procedures. The recall affects 184 kits.

The kits are being recalled because they contain 3M Health Care Steri Drapes that have been subject to a prior FDA recall. The FDA has classified this as a Class II recall. The specific defect associated with the Steri Drapes is not detailed in this notice.

The kits were distributed across Alabama, Arizona, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Tennessee, Texas, Virginia, and Wisconsin.

Healthcare facilities that received affected kits should discontinue use and verify their inventory against the affected lot numbers: Lot 56073866 (expires 12/1/2023), Lot 56618070 (expires 10/1/2024), Lot 57001434 (expires 2/1/2025), and Lot 57392105 (expires 2/3/2025). Affected parties should contact DeRoyal Industries Inc for return or replacement instructions.

The recalled product

Product
GEO-MED PODIATRY PACK PGYBK, REF 89-6240.05
Manufacturer
DeRoyal Industries Inc
Hazard
  • recalled-component

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 (4)

  • Lot Numbers: Lot 56073866 exp 12/1/2023
  • Lot 56618070 exp 10/1/2024
  • Lot 57001434 exp 2/1/2025
  • Lot 57392105 exp 2/3/2025

Distribution

Distribution scope not specified by the agency.