FDA Recalls DeRoyal Biopsy Packpack Medical Device across Multiple States
DeRoyal Industries is recalling 120 units of Biopsy Packpack medical devices distributed across 23 states. The specific reason for the recall is not disclosed in the FDA 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: This is a Class II medical device recall initiated voluntarily by the manufacturer. Class II recalls do not involve imminent health hazards. No illnesses or injuries have been reported. The specific defect is not disclosed in the FDA notice.
Plain-English summary
DeRoyal Industries Inc has initiated a voluntary recall of the DeRoyal Biopsy Packpack medical device, model REF 89-9756.05. A total of 120 units with lot number 56842493 (expiration 8/1/2026) are affected. The specific reason for this recall is not provided in the FDA recall notice.
The recalled devices were distributed to medical facilities in 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 recall was initiated on November 3, 2022, and was classified as Class II by the FDA on December 15, 2022.
Consumers and healthcare facilities should cease use of the affected lot immediately. If you have received this device, contact DeRoyal Industries Inc for further instructions. For more information, refer to the FDA recall number Z-0705-2023.
The recalled product
- Product
- DeRoyal BIOPSY PACKPACK, REF 89-9756.05
- 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 (1)
- Lot Numbers: Lot 56842493 exp 8/1/2026
Distribution
Distribution scope not specified by the agency.
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