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.
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 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
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
Distribution scope not specified by the agency.
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