The Recall Desk
ModerateFDA (Devices)·Z-0688-2023·Announced 2022-12-21

FDA Recalls DeRoyal PAIN TRAY Medical Device, Model 89-10464.03

DeRoyal Industries has issued a voluntary recall of 150 kits of the DeRoyal PAIN TRAY (Model 89-10464.03, Lot 57752107, expires 12/1/2026). The specific reason for the recall was not disclosed in the FDA 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 an FDA Class II voluntary recall initiated by the manufacturer with no reported adverse events, injuries, or deaths. The absence of reported patient harm and the voluntary nature of the recall place this in the Moderate category per the rubric.

Plain-English summary

DeRoyal Industries Inc is recalling 150 kits of the DeRoyal PAIN TRAY, Model 89-10464.03 (Lot 57752107, expiration date 12/1/2026). The recall affects units distributed across 23 US states including 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 FDA classification for this recall is Class II. The recall was voluntarily initiated by the manufacturer on November 3, 2022. The specific reason for the recall was not disclosed in the FDA notice.

If you have received this product, do not use it. Contact DeRoyal Industries Inc immediately to arrange for return or replacement of the affected kits. The manufacturer initially notified healthcare facilities by email, fax, letter, press release, telephone, or in-person visit.

The recalled product

Product
DeRoyal PAIN TRAY, REF 89-10464.03
Manufacturer
DeRoyal Industries Inc
Category
Medical Device

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 57752107 exp 12/1/2026

Distribution

Distribution scope not specified by the agency.

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