The Recall Desk
ModerateFDA (Devices)·Z-0696-2023·Announced 2022-12-21

FDA Medical Device Recall: DeRoyal GU Pack genitourinary kits

DeRoyal Industries initiated a voluntary recall of 75 genitourinary (GU) pack kits (Lot 55971461, exp. 5/1/2024). The specific reason for recall is not disclosed in available FDA 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: FDA Class II recall with no reported hospitalizations, injuries, or illnesses documented. Recall was voluntary and firm-initiated, consistent with precautionary or minor defect classifications under the FDA severity rubric.

Plain-English summary

DeRoyal Industries Inc initiated a voluntary recall of 75 DeRoyal GU PACK kits (Reference 89-10665.02, Lot 55971461, expiration 5/1/2024). The FDA classified this as a Class II recall, initiated on November 3, 2022.

The specific reason for the recall is not stated in the FDA documentation. Consumers or healthcare facilities in possession of affected kits should refer to the FDA recall notice or contact DeRoyal Industries Inc for additional information.

The affected lot was distributed across 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 recalled product

Product
DeRoyal GU PACK, REF 89-10665.02
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Genitourinary
Hazard
  • device-defect

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 55971461 exp 5/1/2024

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category