DeRoyal laminectomy surgical instrument kits subject to Class II recall
DeRoyal Industries is recalling LAMINECTOMY PACK surgical kits (Lot 56388471) distributed in multiple US states. Healthcare facilities with affected kits should verify their inventory and contact the manufacturer for guidance.
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 a voluntary FDA Class II medical device recall with no reported injuries or illnesses. The specific hazard has not been identified in available information. In the absence of reported adverse events, this appears to be a precautionary recall initiated by the manufacturer.
Plain-English summary
DeRoyal Industries Inc has issued a voluntary recall of the DeRoyal LAMINECTOMY PACK surgical instrument kit (Reference 89-10209.02). Twelve kits from Lot 56388471, expiring 6/1/2026, are subject to this recall.
The affected kits have been distributed to healthcare facilities across multiple 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.
DeRoyal Industries initiated this recall voluntarily and notified customers through multiple channels including email, fax, letter, press release, telephone, and direct visits. Healthcare facilities that may have received these kits should verify their inventory against the affected lot number and contact DeRoyal Industries for guidance on proper handling or return procedures.
The recalled product
- Product
- DeRoyal LAMINECTOMY PACK, REF 89-10209.02
- Manufacturer
- DeRoyal Industries Inc
- Affected units
- 12
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 56388471 exp 6/1/2026
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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