Z-1938-2026Class II

Diversatek Healthcare

Recalling firm

Product type

Device

Status

Ongoing

Report date

2026-04-29

Distribution

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

Firm state

Product quantity

15 units

Initiated by

Voluntary: Firm initiated

SPEQ quality domain

Documentation & Change Control

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.

Product description

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

Code / lot info

UDI/DI 00816734021699, Lot Numbers: 005983

Other recalls SPEQ maps to Documentation & Change Control

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See all Documentation & Change Control recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.