The Recall Desk
ModerateFDA (Devices)·Z-0697-2023·Announced 2022-12-21

DeRoyal GU PACK Medical Device Voluntary Recall

DeRoyal Industries Inc voluntarily recalled 57 kits of the DeRoyal GU PACK medical device. The specific reason for the recall was not provided in the available 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 an FDA Class II voluntary recall with no reported illnesses or injuries in the source material. The specific hazard or reason was not provided in available documentation. Based on the voluntary nature of the recall and absence of reported harm, this meets the criteria for Moderate severity.

Plain-English summary

DeRoyal Industries Inc initiated a voluntary recall of 57 kits of the DeRoyal GU PACK (REF 89-10665.03) beginning November 3, 2022. The affected product is Lot 57590304, which expired June 1, 2023.

The recalled devices were distributed to multiple 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.

This is a Class II medical device recall. The manufacturer initiated the recall voluntarily. The specific reason or hazard associated with the product was not included in the available source documentation. Consumers or healthcare providers who have this device should contact DeRoyal Industries Inc for additional information regarding the recall.

The recalled product

Product
DeRoyal GU PACK, REF 89-10665.03
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Genitourinary Surgical Pack
Affected units
57

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 57590304 exp 6/1/2023

Distribution

Distributed in 23 states:

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.

See all 156 products in this recall →

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