# FDA recall Z-0414-2022

> **Cook Inc.** · Class II · device recall initiated 2021-10-13.

## Product

Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290.    Rigid needle available with EchoTip to provide enhanced visualization of needle tip when used with ultrasonic imaging equipment.

## Reason for recall

Specific lots may contain black debris on the exterior of the inner stylet and/or on the interior of the outer cannula. Local inflammatory reactions may occur if an affected product is used.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of AL, CA, IN, LA, MS, MT, NC, NY, OR, PA, WA and the countries of France, Italy, and Mexico.

## Key facts

- **Recall number:** Z-0414-2022
- **Recalling firm:** Cook Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-10-13
- **Report date:** 2021-12-29

- **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-0414-2022

## Citation

> AI Analytics. FDA recall Z-0414-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0414-2022. Source: US FDA. Licensed CC0.

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