# FDA recall Z-1460-2025

> **MEDLINE INDUSTRIES, LP - Northfield** · Class II · device recall initiated 2025-02-06.

## Product

Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters, Medline Item Numbers: 401582R, 401904R, 401904R, 401905R, 401933R, and 401991R

## Reason for recall

Devices may have higher than expected amounts of bacterial endotoxin.

## Distribution

US Nationwide distribution in the states of AR, AZ, CA, CO, IA, IL, KS, OR, TN, TX, WA, and WI.

## Key facts

- **Recall number:** Z-1460-2025
- **Recalling firm:** MEDLINE INDUSTRIES, LP - Northfield
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-02-06
- **Report date:** 2025-04-02

- **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-1460-2025

## Citation

> AI Analytics. FDA recall Z-1460-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1460-2025. Source: US FDA. Licensed CC0.

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