FDA Recalls 75 DeRoyal UNIVERSAL PACK Medical Device Kits
DeRoyal Industries has voluntarily recalled 75 DeRoyal UNIVERSAL PACK kits (Ref 89-9558.03) distributed across 23 US states. The specific reason for the recall has not been 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: This is a voluntary FDA Class II medical device recall with no reported illnesses or injuries. The source does not disclose the specific reason for recall. Voluntary precautionary recalls absent any reported harm are classified as Moderate per the severity rubric.
Plain-English summary
DeRoyal Industries Inc has initiated a voluntary recall of the DeRoyal UNIVERSAL PACK (Reference 89-9558.03), a medical device product. The recall affects 75 kits that were distributed to healthcare facilities across multiple US states.
The affected lots are: Lot 56187476 (expires 12/1/2026) and Lot 57190116 (expires 4/1/2027). Distribution was reported to the following 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 has not been disclosed in the available source documentation. Healthcare providers who have received these kits should contact DeRoyal Industries Inc for further information and instructions regarding the recalled products.
The recalled product
- Product
- DeRoyal UNIVERSAL PACK, REF 89-9558.03
- Manufacturer
- DeRoyal Industries Inc
- Category
- Medical Device
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 56187476 exp 12/1/2026
- Lot 57190116 exp 4/1/2027
Distribution
Distribution scope not specified by the agency.
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