DeRoyal Laparoscopic Robotic Tray Class II Medical Device Recall
DeRoyal Industries initiated a voluntary recall of 30 kits of a laparoscopic robotic surgical tray (Model 89-7063.11). The reason for the recall is not specified in available FDA records.
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: This is an FDA Class II voluntary recall with no reported injuries or illnesses. The specific hazard is not documented, consistent with a precautionary recall rather than response to known harm.
Plain-English summary
DeRoyal Industries Inc. initiated a voluntary recall of 30 kits of its laparoscopic robotic surgical tray (Reference 89-7063.11, Lot 57085711 expiring 9/1/2025) on November 3, 2022. This FDA Class II medical device is used in minimally invasive surgical procedures. The specific reason for the recall was not documented in available FDA records.
The affected devices were distributed to 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. Healthcare facilities that received these kits should contact DeRoyal Industries Inc. for further guidance regarding the affected lot.
The recalled product
- Product
- DeRoyal LAPAROSCOPIC ROBOTIC TRAY, REF 89-7063.11
- Manufacturer
- DeRoyal Industries Inc
- Affected units
- 30
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 57085711 exp 9/1/2025
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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