# FDA recall Z-0995-2026

> **Cook Incorporated** · Class II · device recall initiated 2025-11-26.

## Product

R¿sch-Uchida Transjugular Liver Access Sets, Reference Part Numbers:  RUPS-100;   The R¿sch-Uchida Transjugular Liver Access Set is intended for transjugular liver access in diagnostic and interventional  procedures.

## Reason for recall

Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly.

## Distribution

Worldwide distribution.

## Key facts

- **Recall number:** Z-0995-2026
- **Recalling firm:** Cook Incorporated
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-11-26
- **Report date:** 2025-12-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bloomington, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0995-2026

## Citation

> AI Analytics. FDA recall Z-0995-2026. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0995-2026. Source: US FDA. Licensed CC0.

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