# FDA recall Z-2042-2020

> **Medline Industries Inc** · Class II · device recall initiated 2019-05-28.

## Product

SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 6 Fr 1.5 ml - Product Usage: Medline Silicone Foley catheter is a flexible tubular device that is inserted through the urethra and used to drain urine into a collection device.

## Reason for recall

Loose silicone particulate was found to be present on the shaft of the silicone catheters.

## Distribution

US Nationwide distribution including in the states of CO, IL, KY, MO, NJ, OR, TN, TX, VA, WA.

## Key facts

- **Recall number:** Z-2042-2020
- **Recalling firm:** Medline Industries Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-05-28
- **Report date:** 2020-05-27
- **Termination date:** 2023-01-30

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2042-2020

## Citation

> AI Analytics. FDA recall Z-2042-2020. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-2042-2020. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*