The Recall Desk
ModerateFDA (Devices)·Z-0687-2023·Announced 2022-12-21

Medical device manufacturer recalls pain trays in 23 US states

DeRoyal Industries is voluntarily recalling 1,100 kits of pain tray devices distributed across 23 US states. The FDA classified this as a Class II recall.

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 voluntary precautionary recall with no reported illnesses or injuries. The recall meets the rubric criterion for Moderate severity (voluntary precautionary recalls).

Plain-English summary

DeRoyal Industries Inc is voluntarily recalling 1,100 kits of its DeRoyal PAIN TRAY medical devices (Reference number 89-10464.02). The devices were distributed to healthcare facilities in 23 US 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 lot numbers are: Lot 55971883 (expires 7/1/2026), Lot 56477511 (expires 7/1/2026), and Lot 57002921 (expires 9/1/2026). The recall was initiated on November 3, 2022, and remains ongoing.

Healthcare providers and facilities that received these pain trays should contact DeRoyal Industries for recall instructions. The manufacturer initiated this recall voluntarily and notified healthcare providers through multiple channels including email, fax, letters, press releases, telephone contact, and direct facility visits.

The recalled product

Product
DeRoyal PAIN TRAY, REF 89-10464.02
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Medical supplies / Hospital equipment
Affected units
1,100

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 (3)

  • Lot Numbers: Lot 55971883 exp 7/1/2026
  • Lot 56477511 exp 7/1/2026
  • Lot 57002921 exp 9/1/2026

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 →

Related recalls

Same manufacturer · DeRoyal Industries Inc

See all →