The Recall Desk
ModerateFDA (Devices)·Z-0681-2023·Announced 2022-12-21

FDA Recalls DeRoyal Pacemaker ICD Pack, Lot 57898501

DeRoyal Industries voluntarily recalled 75 units of its PACEMAKER ICD PACK (REF 89-10216.06, Lot 57898501) distributed across 23 US states on November 3, 2022.

What this means for you

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 recall initiated voluntarily by the firm with no reported illnesses or injuries. Classified as a precautionary measure.

Plain-English summary

DeRoyal Industries Inc issued a voluntary recall of its PACEMAKER ICD PACK (model REF 89-10216.06). The recall affects 75 kits distributed across 23 US states. The FDA classified this recall as Class II.

Affected units are from Lot 57898501, with an expiration date of March 1, 2027. The recall was initiated on November 3, 2022.

Patients and healthcare providers who have received units from this lot should contact DeRoyal Industries Inc for additional information about the recall and guidance on next steps. Patients should not discontinue use of their devices without consulting their healthcare provider.

The recalled product

Product
DeRoyal PACEMAKER ICD PACK, REF 89-10216.06
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Cardiac / Pacemaker
Affected units
75

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 57898501 exp 3/1/2027

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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