FDA Class II Recall of DeRoyal Myelogram Pack Kits
DeRoyal Industries voluntarily recalled 2,280 myelogram pack kits across 23 U.S. states. No specific reason for the recall was provided in the official notice.
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 recalls indicate moderate risk. This is a voluntary, firm-initiated recall with no reported illnesses or injuries mentioned in the source material, supporting a moderate rather than severe classification.
Plain-English summary
DeRoyal Industries Inc is voluntarily recalling the DeRoyal Myelogram Pack, Reference 89-9304.05, affecting 2,280 kits distributed to healthcare facilities across 23 U.S. 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 this recall was not provided in the FDA notice. The affected lot numbers and their expiration dates are: Lot 55612944 (expires 3/1/2026), Lot 56615881 (expires 7/1/2026), Lot 56279557 (expires 5/1/2026), Lot 57185350 (expires 7/1/2026), and Lot 57591593 (expires 1/1/2025).
Healthcare facilities and individuals who have received kits with these lot numbers should consult with DeRoyal Industries or the FDA for further guidance. The recall was initiated on November 3, 2022, and remains ongoing as of the latest update.
The recalled product
- Product
- DeRoyal MYELOGRAM PACK, REF 89-9304.05
- Manufacturer
- DeRoyal Industries Inc
- Category
- Medical Device — Diagnostic Kit
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 (5)
- Lot Numbers: Lot 55612944 exp 3/1/2026
- Lot 56615881 exp 7/1/2026
- Lot 56279557 exp 5/1/2026
- Lot 57185350 exp7/1/2026
- Lot 57591593 exp 1/1/2025
Distribution
Distribution scope not specified by the agency.
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