# FDA recall Z-1940-2026

> **Diversatek Healthcare** · Class II · device recall initiated 2026-03-18.

## Product

Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 15mm-16.5mm-18mm, REF 1205-18

## Reason for recall

The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.

## Distribution

US:  MO, CA, FL, TX, AZ, PA, RI, NC, IL, MS, KS, NY, OH, VA, LA, IA, MI, NJ, AL, Brazil, Belgium

## Key facts

- **Recall number:** Z-1940-2026
- **Recalling firm:** Diversatek Healthcare
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-03-18
- **Report date:** 2026-04-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Milwaukee, WI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1940-2026

## Citation

> AI Analytics. FDA recall Z-1940-2026. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-1940-2026. Source: US FDA. Licensed CC0.

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