FDA Recalls DeRoyal Lapinectomy Surgical Pack Kits
The FDA is recalling 403 kits of DeRoyal lapinectomy packs distributed across 23 US states. The specific reason for the recall is not provided in the source 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 Class II device recall initiated voluntarily by the manufacturer with no reported illnesses, injuries, or hospitalizations documented in the source. The specific reason for the recall is not stated in the available documentation. Without evidence of harm or a documented hazard, this is classified as a voluntary precautionary recall.
Plain-English summary
DeRoyal Industries Inc is voluntarily recalling 403 DeRoyal LAPINECTOMY PACK kits (Reference 89-7198.10) distributed to medical facilities across the United States. The affected products were distributed to 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 affected lot numbers are Lot 56612971 and Lot 56802580, both with expiration dates of July 1, 2026. The recall was initiated on November 3, 2022, and the FDA classified it as Class II on December 15, 2022.
DeRoyal Industries Inc voluntarily initiated this recall through multiple notification methods including email, fax, letter, press release, telephone, and direct facility visits. Healthcare providers and facilities that received these kits should contact DeRoyal Industries Inc if they have questions about the recall or need further information.
The recalled product
- Product
- DeRoyal LAPINECTOMY PACK, REF 89-7198.10
- 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 (2)
- Lot Numbers: Lot 56612971 exp 7/1/2026
- Lot 56802580 exp 7/1/2026
Distribution
Distribution scope not specified by the agency.
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