# FDA recall Z-0675-2025

> **Cardinal Health 200, LLC** · Class II · device recall initiated 2024-11-01.

## Product

Cardinal Health SMS Elastic Cuff Thumbhook Level 3 Isolation Gown, Full-Back, Product Codes AT6588-2XL, AT6588-BD, AT6588-XL, AT6688-2XL, AT6688-BD, and AT6688-XL

## Reason for recall

Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure specification and therefore would not comply with AAMI (The Association for the Advancement of Medical Instrumentation) Level 3 protection requirements.

## Distribution

US Nationwide. Canada, UAE

## Key facts

- **Recall number:** Z-0675-2025
- **Recalling firm:** Cardinal Health 200, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-11-01
- **Report date:** 2024-12-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waukegan, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0675-2025

## Citation

> AI Analytics. FDA recall Z-0675-2025. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0675-2025. Source: US FDA. Licensed CC0.

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