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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Affected units
- 68
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
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.
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