Diversatek Healthcare Viper 3-Stage Fixed Wire Balloon Dilator
Diversatek Healthcare is recalling Viper 3-Stage Fixed Wire Balloon Dilators due to incorrect inflation tag labeling.
Check the catheter inflation tag on your device. If the information on the tag does not match the intended specifications for your procedure, discontinue use and contact Diversatek Healthcare for further instructions.
Why it was recalled
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.
How to identify it
UPC 00816734021699
Diversatek Healthcare Viper¿ 3-Stage Fixed Wire Balloon Dilator, 6mm-7mm-8mm, REF 1204-08
Where it was sold
Distributed in US-AL, US-AZ, US-CA, US-FL, US-IA, US-IL, US-KS, US-LA, US-MI, US-MO, US-MS, US-NC, US-NJ, US-NY, US-OH, US-PA, US-RI, US-TX, US-VA.
Official source
Editorial summary by Recall Canary · last updated 2026-06-05 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification