Medical Device Class II Recall: DeRoyal LAMI/CRANI PACK surgical kits
DeRoyal Industries is recalling 36 kits of the LAMI/CRANI PACK (lot numbers 56219159 and 56593562, expiring 4/1/2026) distributed across 23 US states. This is a voluntary Class II device recall; the specific reason was not disclosed in available documentation.
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 device recall with no reported injuries, illnesses, or identified hazard details in the source documentation. As a voluntary, precautionary recall without incident reports, it is classified as Moderate.
Plain-English summary
DeRoyal Industries Inc. is recalling 36 kits of the DeRoyal LAMI/CRANI PACK, Reference 89-10787.01. The affected lot numbers are 56219159 and 56593562, both expiring April 1, 2026.
The recalled kits were distributed across 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.
This is a voluntary Class II device recall initiated by the manufacturer on November 3, 2022. The specific reason for the recall was not disclosed in available FDA documentation. Healthcare facilities and distributors that received the affected kits should contact DeRoyal Industries for guidance on handling the affected units.
The recalled product
- Product
- DeRoyal LAMI/CRANI PACK, REF 89-10787.01
- Manufacturer
- DeRoyal Industries Inc
- Affected units
- 36
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 56219159 exp 4/1/2026
- Lot 56593562 exp 4/1/2026
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.
See all 156 products in this recall →Related recalls
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