# FDA recall Z-1935-2026

> **Cook Incorporated** · Class I · device recall initiated 2026-04-02.

## Product

Aurous Centimeter Sizing Catheter  RPN N5.0-35-100-P-10S-PIG-CSC-20-01  GPN G47308    Sizing catheters are single-use, sterile catheters with gold marker bands. These catheters are for use in angiographic procedures and available in a variety of lengths (70 and 100 cm) and tip configurations (straight, PIG, and VCF).

## Reason for recall

Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.

## Distribution

US distribution nationwide. OUS distribution to Brunei, Brazil, Canda, China, Colombia, Costa Rica, Hong Kong, Israel, India, Japan, South Korea, Macau, New Zealand, Singapore, El Salvador, Taiwan, Uruguay

## Key facts

- **Recall number:** Z-1935-2026
- **Recalling firm:** Cook Incorporated
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-04-02
- **Report date:** 2026-05-13

- **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-1935-2026

## Citation

> AI Analytics. FDA recall Z-1935-2026. Retrieved 2026-07-17 from https://api.ai-analytics.org/recall/Z-1935-2026. Source: US FDA. Licensed CC0.

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