FDA Issues Class II Recall for DeRoyal SPINE PACK Medical Device Kits
DeRoyal Industries Inc recalled 243 SPINE PACK medical device kits distributed across 23 US states as a Class II FDA recall. The specific reason for the recall is not detailed in the available 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 recall initiated voluntarily by the manufacturer, consistent with precautionary recall classification.
Plain-English summary
DeRoyal Industries Inc has voluntarily recalled 243 DeRoyal SPINE PACK medical device kits (REF 89-8361.08) pursuant to a Class II FDA recall (Z-0613-2023). The recall affects two lot numbers: Lot 56189228 (expires 4/1/2026) and Lot 56614415 (expires 2/1/2026).
The devices were distributed across 23 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 specific reason for the recall is not detailed in the FDA recall documentation. Healthcare providers and consumers who have received or used these devices should consult the FDA notice Z-0613-2023 for further guidance.
The recalled product
- Product
- DeRoyal SPINE PACK, REF 89-8361.08
- Manufacturer
- DeRoyal Industries Inc
- Category
- Medical Device — Surgical
- Affected units
- 243
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 (2)
- Lot Numbers: Lot 56189228 exp 4/1/2026
- Lot 56614415 exp 2/1/2026
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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