FDA Class II Recall: DeRoyal Lapinectomy Pack Surgical Kits
DeRoyal Industries initiated a voluntary recall of 715 Lapinectomy Pack surgical kits (Ref 89-7198.11) distributed to 23 US states. The FDA Class II recall remains ongoing.
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 voluntary device recall initiated by the manufacturer. No illnesses, injuries, or deaths are reported in the source. Classified as a precautionary recall matching the rubric criterion for voluntary recalls with no specified serious hazard.
Plain-English summary
DeRoyal Industries Inc initiated a voluntary recall of 715 DeRoyal Lapinectomy Pack surgical kits (Reference 89-7198.11). The recall was initiated on November 3, 2022, and remains ongoing. It is classified as FDA Class II.
The affected kits were distributed to healthcare facilities across 23 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 kits are from four specific lot numbers with the following expiration dates: Lot 57091046 (expires July 1, 2026), Lot 57224911 (expires May 1, 2026), Lot 57387648 (expires August 1, 2026), and Lot 57748491 (expires October 1, 2026). Healthcare facilities should verify whether they received these products and contact DeRoyal Industries Inc or the FDA for further guidance.
The recalled product
- Product
- DeRoyal LAPINECTOMY PACK, REF 89-7198.11
- Manufacturer
- DeRoyal Industries Inc
- Affected units
- 715
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 (4)
- Lot Numbers: Lot 57091046 exp 7/1/2026
- Lot 57224911 exp 5/1/2026
- Lot 57387648 exp 8/1/2026
- Lot 57748491 exp 10/1/2026
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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