# FDA recall Z-2785-2026

> **Medline Industries, LP** · Class II · device recall initiated 2026-06-08.

## Product

Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons.    RR-DAVINCI PROSTATE ACCESSORY	  	DYNJ63392F

## Reason for recall

Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.

## Distribution

US Nationwide distribution in the states of CA, FL, MD. PA, and TX.

## Key facts

- **Recall number:** Z-2785-2026
- **Recalling firm:** Medline Industries, LP
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-06-08
- **Report date:** 2026-07-29

- **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-2785-2026

## Citation

> AI Analytics. FDA recall Z-2785-2026. Retrieved 2026-09-02 from https://api.ai-analytics.org/recall/Z-2785-2026. Source: US FDA. Licensed CC0.

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