The Recall Desk
Agency classClass IIOur severity: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.

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 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
Affected units
150

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

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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