The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0629-2023·Announced 2022-12-21

Medical Device: DeRoyal HEART B PACK Recalled by FDA

DeRoyal Industries initiated a Class II recall of its HEART B PACK medical device kit affecting 68 units distributed across 23 US states (Lot 56613762, expires 6/1/2026). The specific reason for recall is not available in source documentation.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This recall involves a cardiac medical device kit classified as FDA Class II. Cardiac medical devices are inherently risk-of-harm products; no injuries or illnesses have been reported in available source documentation. This warrants a High severity classification due to the nature of the product and its direct involvement with patient care.

Plain-English summary

DeRoyal Industries Inc is recalling the HEART B PACK medical device kit (Model/Reference 89-9042.07) following a Class II recall classification from the FDA.

The recall was initiated by the manufacturer on November 3, 2022. A total of 68 kits with lot number 56613762 (expiration date 6/1/2026) have been affected. The specific reason for the recall is not documented in available source materials.

The affected 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.

Consumers or healthcare facilities in possession of affected units should contact DeRoyal Industries Inc at the company's Powell, Tennessee facility or the FDA for further guidance on product disposition and next steps.

The recalled product

Product
DeRoyal KIT HEART B PACK, REF 89-9042.07
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Cardiac Device
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 56613762 exp 6/1/2026

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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