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.
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: 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
- 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
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.
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