The Recall Desk
ModerateFDA (Devices)·Z-0593-2023·Announced 2022-12-21

Medical device recall: DeRoyal VIT RD PACK 86ST, FDA Class II

DeRoyal Industries recalls 16 kits of DeRoyal VIT RD PACK 86ST medical devices distributed across 23 US states. This is a voluntary firm-initiated FDA Class II recall.

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 voluntary firm-initiated recall with no reported illnesses or injuries. The precautionary nature and absence of reported adverse events indicate moderate severity. Class II classification reflects potential for temporary or medically reversible adverse health consequences, supporting a moderate rather than low severity rating.

Plain-English summary

DeRoyal Industries Inc is recalling 16 kits of the DeRoyal VIT RD PACK 86ST (Reference number 89-7308.09) medical device. The affected product lot numbers are Lot 57784627 (expiration date 4/1/2025) and Lot 57974922 (expiration date not provided in the recall notice).

The products were distributed across 23 US 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 recall status is listed as ongoing.

DeRoyal Industries initiated this voluntary recall on November 3, 2022. The FDA received notification on December 21, 2022, and classified it as a Class II recall, indicating potential for temporary or medically reversible adverse health consequences. However, the specific reason for the recall is not disclosed in the FDA notice.

Consumers and healthcare providers who have this product should contact DeRoyal Industries Inc for information about what actions to take regarding affected units.

The recalled product

Product
DeRoyal VIT RD PACK 86ST, REF 89-7308.09
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Medical Pack
Affected units
16

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 (2)

  • Lot Numbers: Lot 57784627 exp 4/1/2025
  • Lot 57974922 exp ***

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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