The Recall Desk
ModerateFDA (Devices)·Z-0639-2023·Announced 2022-12-21

DeRoyal Foot Pack Medical Device Class II Recall

DeRoyal Industries has initiated a voluntary Class II recall of 217 kits of its DeRoyal Foot Pack (REF 89-9252.07). The recall affects multiple U.S. states.

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 device recall voluntarily initiated by the firm with no reported illnesses or injuries, consistent with a precautionary measure.

Plain-English summary

DeRoyal Industries Inc, based in Powell, Tennessee, has voluntarily recalled 217 kits of the DeRoyal FOOT PACK (REF 89-9252.07), a medical device. The recall was initiated on November 3, 2022, and remains ongoing as of the December 21, 2022 report date.

The recall affects the following U.S. 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. The affected products carry the following lot numbers: Lot 57171601 (expiration 10/1/2024) and Lot 57505843 (expiration 1/1/2025).

No illnesses or injuries have been reported. The company notified healthcare facilities and customers through email, fax, letter, press release, telephone, and direct visits. Facilities and individuals who have received these products should verify lot numbers and discontinue use of affected units.

The recalled product

Product
DeRoyal FOOT PACK, REF 89-9252.07
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Foot Pack
Affected units
217

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 57171601 exp 10/1/2024
  • Lot 57505843 exp 1/1/2025

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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