FDA Medical Device Recall: DeRoyal GU Pack genitourinary kits
DeRoyal Industries initiated a voluntary recall of 75 genitourinary (GU) pack kits (Lot 55971461, exp. 5/1/2024). The specific reason for recall is not disclosed in available FDA 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 recall with no reported hospitalizations, injuries, or illnesses documented. Recall was voluntary and firm-initiated, consistent with precautionary or minor defect classifications under the FDA severity rubric.
Plain-English summary
DeRoyal Industries Inc initiated a voluntary recall of 75 DeRoyal GU PACK kits (Reference 89-10665.02, Lot 55971461, expiration 5/1/2024). The FDA classified this as a Class II recall, initiated on November 3, 2022.
The specific reason for the recall is not stated in the FDA documentation. Consumers or healthcare facilities in possession of affected kits should refer to the FDA recall notice or contact DeRoyal Industries Inc for additional information.
The affected lot was distributed 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 recalled product
- Product
- DeRoyal GU PACK, REF 89-10665.02
- Manufacturer
- DeRoyal Industries Inc
- Category
- Medical Device — Genitourinary
- Hazard
- Affected units
- 75
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 (1)
- Lot Numbers: Lot 55971461 exp 5/1/2024
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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