# FDA recall Z-0090-2019

> **Sterilmed, Inc.** · Class II · device recall initiated 2018-09-17.

## Product

Reprocessed Agilis Steerable Introducer:  indicated for introducing various cardiovascular catheters into the heart.    (a) small curl (16.8mm curve type/71 cm length), Product Code STJ408309;    (b) medium curl (22.4 mm curve type/71 cm length), Product Code STJ408310;    (c) large curl (50 mm curve type/71 cm length), Product Code STJ408324

## Reason for recall

Reprocessed Agilis Steerable Introducers may not meet endotoxin requirements per product specification for biological residues determined by LAL testing.

## Distribution

U.S. Nationwide distribution in the states of  CA, CO, MN, and WA.

## Key facts

- **Recall number:** Z-0090-2019
- **Recalling firm:** Sterilmed, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-09-17
- **Report date:** 2018-10-17
- **Termination date:** 2020-08-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Plymouth, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0090-2019

## Citation

> AI Analytics. FDA recall Z-0090-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0090-2019. Source: US FDA. Licensed CC0.

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