# FDA recall Z-1324-2026

> **Medline Industries, LP** · Class I · device recall initiated 2025-12-22.

## Product

Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters:    Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on GE Systems  10439072RH;    Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on Siemens Systems  10438577RH;    Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter, Use on Siemens Systems  10439011RH

## Reason for recall

These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025

## Distribution

Distribution US nationwide.

## Key facts

- **Recall number:** Z-1324-2026
- **Recalling firm:** Medline Industries, LP
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-12-22
- **Report date:** 2026-02-18

- **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-1324-2026

## Citation

> AI Analytics. FDA recall Z-1324-2026. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1324-2026. Source: US FDA. Licensed CC0.

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