FDA recall Z-1938-2026

Product

Diversatek Healthcare Viper¿ 3-Stage Fixed Wire Balloon Dilator, 6mm-7mm-8mm, REF 1204-08

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

Status

Ongoing

Initiation date

2026-03-18

Report date

2026-04-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Milwaukee, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1938-2026