The Recall Desk
HighFDA (Devices)·Z-0703-2023·Announced 2022-12-21

FDA Medical Device Recall: DeRoyal Pacemaker ICD Pack

DeRoyal Industries initiated a voluntary recall of its PACEMAKER ICD PACK (Lot 57805969, exp. 11/1/2026). The specific reason for recall is not provided in available source documentation. Affected units were distributed across 23 U.S. states.

What this means for you

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: Pacemakers and implantable cardioverter defibrillators are risk-of-harm medical devices. This Class II recall involves life-sustaining equipment with no reported illnesses or injuries. Per the severity rubric, risk-of-harm products where injury has not yet been reported are classified as High.

Plain-English summary

DeRoyal Industries Inc has voluntarily recalled the DeRoyal PACEMAKER ICD PACK, REF 89-10902.01. The recall affects 60 kits distributed across 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 affected lot is 57805969, with an expiration date of November 1, 2026. This is a Class II device recall initiated voluntarily by the manufacturer. The specific reason or defect associated with this recall is not provided in available source documentation.

Individuals with potentially affected units should contact their healthcare provider or DeRoyal Industries for specific guidance and instructions, as the nature of the defect and recommended corrective actions are not specified in the source.

The recalled product

Product
DeRoyal PACEMAKER ICD PACK, REF 89-10902.01
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Pacemaker / Implantable Cardioverter Defibrillator
Affected units
60

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 57805969 exp 11/1/2026

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 →

Related recalls

Same manufacturer · DeRoyal Industries Inc

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