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.
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: 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
- 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
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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