Class II

Medical Device Recall: Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 12mm-13.5mm-15mm, REF 1205-15

Diversatek Healthcare · March 18, 2026

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

States Affected

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

Quantity Affected

527 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1939-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.