# FDA recall Z-2453-2024

> **Angiodynamics, Inc.** · Class II · device recall initiated 2024-06-18.

## Product

SOFT-VU KUMPE 5F X 40CM -Used for patients in need of angiographic diagnosis.  Catalog Number: 10732702

## Reason for recall

Mislabeled. The shelf-box labeling (unit of sale) is accurate for the packaged devices, however the inner pouch label may contain information for a different model (catheter length)

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-2453-2024
- **Recalling firm:** Angiodynamics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-06-18
- **Report date:** 2024-08-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Queensbury, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2453-2024

## Citation

> AI Analytics. FDA recall Z-2453-2024. Retrieved 2026-07-18 from https://api.ai-analytics.org/recall/Z-2453-2024. Source: US FDA. Licensed CC0.

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