The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0620-2023·Announced 2022-12-21

FDA Recalls GEO-MED Podiatry Pack Medical Device Kit

DeRoyal Industries voluntarily recalls GEO-MED Podiatry Pack medical device kits distributed across 23 US states. The specific reason for recall is not detailed in available source materials.

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: Class II FDA recall with no reported illnesses or injuries in the source material. The voluntary, firm-initiated status and absence of documented safety incidents support a Moderate classification per the rubric for precautionary device recalls.

Plain-English summary

DeRoyal Industries Inc initiated a voluntary recall of the GEO-MED PODIATRY PACK PGYBK (Reference 89-8700.02) medical device kit on November 3, 2022. This Class II recall affects 16 kits distributed across 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 this recall is not provided in the available recall notice. Consumers who have received affected kits bearing lot number 57745716 (expiration October 1, 2024) should contact the manufacturer for guidance.

This is a voluntary, firm-initiated recall classified as FDA Class II. Affected customers were notified through multiple channels including email, fax, letter, press release, telephone, and direct visits.

The recalled product

Product
GEO-MED PODIATRY PACK PGYBK, REF 89-8700.02
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Surgical Supplies
Affected units
16

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 57745716 exp 10/1/2024

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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