# FDA recall Z-2610-2025

> **Medline Industries, LP** · Class I · device recall initiated 2025-07-31.

## Product

Reprocessed Livewire Steerable Electrophysiology Catheter    Item Numbers 401575RH  401582RH  401600RH  401603RH  401606RH  401652RH  401653RH  401654RH  401904RH  401905RH  401908RH  401914RH  401915RH  401918RH  401932RH  401933RH  401934RH  401938RH  401939RH  401940RH  401941RH  401991RH

## Reason for recall

Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection, and if particulate were to dislodge during use and contact circulating blood and/or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.

## Distribution

Domestic US distribution nationwide. International distribution pending. No international distribution.

## Key facts

- **Recall number:** Z-2610-2025
- **Recalling firm:** Medline Industries, LP
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-07-31
- **Report date:** 2025-10-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Northfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2610-2025

## Citation

> AI Analytics. FDA recall Z-2610-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2610-2025. Source: US FDA. Licensed CC0.

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