Medline Industries Recalls Reprocessed Livewire Steerable Electrophysiology Catheters Due to Contamination Risk
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Medline Industries, LP has issued a Class I recall for 41 reprocessed Livewire Steerable Diagnostic Electrophysiology Catheters due to potential residual material contamination.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 6, 2026 and geographically references United States. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, MedicalDevices.
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.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Frequently Asked Questions
Common questions about this FDA recall.