Medline Industries Recalls Reprocessed Livewire Steerable Electrophysiology Catheters Due to Contamination Risk

FDA Recalls high FDA · · United States

Medline Industries, LP has issued a Class I recall for 41 reprocessed Livewire Steerable Diagnostic Electrophysiology Catheters due to potential residual material contamination.

What Happened

Medline Industries, LP has initiated a voluntary recall of specific lots of reprocessed Livewire Steerable Diagnostic Electrophysiology Catheters. The FDA has designated this as a Class I recall, indicating that the use of these devices may cause serious health consequences. The recall was prompted by the discovery that these catheters may contain small particles of residual material from the reprocessing stage.

Which Products Are Affected

The recall affects 41 units distributed nationwide across the United States. The following models and lot numbers are included:

  • Livewire Steerable Electrophysiology Catheter, 10 Elec. 2-5-2mm: Catalog 401582RH (Lots EP250618, EP250630) and 401940RH (Lot EP250618)
  • Livewire Steerable Electrophysiology Catheter, 20 Elec. 2-10-2mm: Catalog 401904RH (Lots EP250618, EP250630)
  • Livewire Steerable Electrophysiology Catheter, 20 Elec. 2-5-2mm: Catalog 401914RH (Lot EP250618)
  • Livewire Steerable Electrophysiology Catheter, 20 Elec. 2-8-2-60-2-8-2mm: Catalog 401932RH (Lots EP250618, EP250630)
  • Livewire Steerable Electrophysiology Catheter, 8 Elec. 2-2-2mm: Catalog 401652RH (Lots EP250618, EP250630)

What You Should Do

Medline Industries notified affected customers via letter on December 22, 2025. Healthcare facilities and providers should immediately check their inventory for the catalog and lot numbers listed above. Affected devices should be quarantined and returned to Medline according to the instructions provided in the firm’s notification letter. For further information, contact Medline Industries, LP at their Northfield, Illinois headquarters.

Why This Matters

The presence of residual material in these medical devices poses a high risk of inflammatory response, systemic infection, or granulomatous reaction. Furthermore, it may trigger a thrombus reaction, potentially leading to life-threatening conditions such as cerebral embolism, pulmonary embolism, or deep vein thrombosis.

Source

This information is based on official recall data provided by the FDA under recall number Z-1321-2026.

Source: FDA Official Notice

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