The Recall Desk
ModerateFDA (Devices)·Z-0584-2023·Announced 2022-12-21

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.

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 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
Category
Medical Device — Surgical Equipment

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

Distribution scope not specified by the agency.

Related recalls

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