The Recall Desk
ModerateFDA (Devices)·Z-0630-2023·Announced 2022-12-21

Medical device recall: DeRoyal cardiac kit Class II

DeRoyal Industries recalled 68 DeRoyal KIT HEART B PACK units (Class II, voluntary). The specific reason for the recall is not documented in the source.

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 recall with no reported illnesses, injuries, or hospitalizations documented in the source. The specific reason for recall is not stated in available documentation, limiting hazard assessment.

Plain-English summary

DeRoyal Industries Inc. initiated a voluntary recall of 68 units of the DeRoyal KIT HEART B PACK (Reference 89-9042.08, Lot 57388270, expiration date 8/1/2026). The FDA classified this as a Class II recall.

The recall was distributed across 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.

The available recall documentation does not specify the reason for the recall or the nature of any hazard. The recall was initiated on November 3, 2022, and communicated to facilities by email, fax, letter, press release, telephone, and in-person visits.

If you have received one of these kits, contact DeRoyal Industries Inc or your healthcare provider for further guidance.

The recalled product

Product
DeRoyal KIT HEART B PACK, REF 89-9042.08
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Cardiac Surgical Kit

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 57388270 exp 8/1/2026

Distribution

Distribution scope not specified by the agency.

Related recalls

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