# FDA recall Z-2267-2024

> **Angiodynamics, Inc.** · Class II · device recall initiated 2024-05-21.

## Product

IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100

## Reason for recall

A single batch of ISO-100 IsoLoc Gas-Release Endorectal Balloons is mislabeled. The  affected ISO-100 balloon catheter has a nominal fill volume of 100cc/ml but the inner pouch identifies the product as an ISO-60 (fill volume of 60cc/ml).

## Distribution

US Nationwide distribution in the states of AZ, FL, IL, MO, MS, NJ, NM, NY, PA, TX, WI.

## Key facts

- **Recall number:** Z-2267-2024
- **Recalling firm:** Angiodynamics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-05-21
- **Report date:** 2024-07-10

- **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-2267-2024

## Citation

> AI Analytics. FDA recall Z-2267-2024. Retrieved 2026-07-11 from https://api.ai-analytics.org/recall/Z-2267-2024. Source: US FDA. Licensed CC0.

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