Class II
Medical Device Recall: Diversatek Healthcare Viper¿ 3-Stage Fixed Wire Balloon Dilator, 6mm-7mm-8mm, REF 1204-08
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
15 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1938-2026
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.