Medical Device Recall: DeRoyal GU Robotic Pack, 192 Kits
DeRoyal Industries has recalled 192 kits of the DeRoyal GU Robotic Pack (Lot 57387066, expires 9/1/2026) distributed across 23 U.S. states. The FDA classified this as a Class II recall.
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 an FDA Class II device recall with no reported illnesses or injuries mentioned in the source. The specific hazard has not been disclosed in the public notice, making it a theoretical risk without documented adverse health events.
Plain-English summary
DeRoyal Industries Inc has initiated a voluntary recall of the DeRoyal GU Robotic Pack (Reference 89-7063.12). A total of 192 kits from Lot 57387066 (expiration date September 1, 2026) have been affected by this recall.
The recalled product 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 specific reason for this FDA Class II recall has not been disclosed in the public recall notice. This classification indicates a potential device defect but does not specify the exact nature of the hazard.
Healthcare facilities and individuals with the affected product should contact DeRoyal Industries Inc for further instructions. The recall remains ongoing.
The recalled product
- Product
- DeRoyal GU ROBOTIC PACK, REF 89-7063.12
- Manufacturer
- DeRoyal Industries Inc
- Hazard
- device-defect
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 57387066 exp 9/1/2026
Distribution
Distribution scope not specified by the agency.
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