# FDA recall Z-2460-2025

> **MEDLINE INDUSTRIES, LP - Northfield** · Class I · device recall initiated 2025-07-14.

## Product

Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Catheter Models  401150RH, 401206RH, 401207RH, 401210RH, 401211RH, 401212RH, 401222RH, 401223RH, 401226RH, 401227RH, 401228RH, 401260RH, 401261RH, 401271RH, 401305RH, 401306RH, 401309RH, 401310RH, 401311RH, 401312RH, 401317RH, 401353RH, 401357RH, 401381RH, 401392RH, 401399RH, 401400RH, 401425RH, 401430RH, 401433RH, 401434RH, 401435RH, 401436RH, 401438RH, 401441RH, 401442RH, 401445RH, 401443RH, 401444RH, 401448RH, 401449RH, 401450RH, 401451RH, 401453RH, 401466RH, 401468RH, 401474RH, 401475RH, 401859RH, 401860RH, 401863RH, 401864RH, 401865RH, 401876RH, 401877RH, 401878RH, 401890RH, 401891RH, 401892RH, 401893RH, 401966RH, 401967RH, 401979RH, 401994RH, 401996RH, 402004RH, 402008RH, 402009RH, 402010RH, 402011RH, 402012RH

## Reason for recall

Specific lots of reprocessed electrophysiology catheters may contain small residual particulates.

## Distribution

US Nationwide.

## Key facts

- **Recall number:** Z-2460-2025
- **Recalling firm:** MEDLINE INDUSTRIES, LP - Northfield
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-07-14
- **Report date:** 2025-09-03

- **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-2460-2025

## Citation

> AI Analytics. FDA recall Z-2460-2025. Retrieved 2026-08-17 from https://api.ai-analytics.org/recall/Z-2460-2025. Source: US FDA. Licensed CC0.

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