FDA recalls 90 DeRoyal pacemaker ICD device packs for defect
DeRoyal Industries is recalling 90 kits of its Pacemaker ICD Pack (Lot 56705350, expiring June 1, 2026) distributed across 23 US states. The specific reason for this voluntary, firm-initiated recall is not disclosed in the FDA notice.
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 is a Class II recall of an implanted cardiac device with no reported illnesses or injuries disclosed. It meets the rubric criterion for Score 3: 'risk-of-harm products where injury has not yet been reported.' Pacemakers and ICD devices are inherently high-risk implanted medical devices.
Plain-English summary
DeRoyal Industries Inc. is recalling 90 kits of the DeRoyal PACEMAKER ICD PACK, Reference 89-10216.03. The affected product is Lot Number 56705350 with an expiration date of June 1, 2026. This implantable cardiac device is used to regulate heart rhythm and treat arrhythmias.
The firm initiated this recall on a voluntary basis, and the recall is currently ongoing. The affected product was 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.
The specific reason or hazard prompting this recall has not been disclosed in the FDA's public notice. Healthcare facilities and providers that have received this product should contact DeRoyal Industries Inc. for further information and instructions regarding the recall.
The recalled product
- Product
- DeRoyal PACEMAKER ICD PACK, REF 89-10216.03
- Manufacturer
- DeRoyal Industries Inc
- Hazard
- Affected units
- 90
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 56705350 exp 6/1/2026
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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