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.
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 2/5 (Moderate).
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
- 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
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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