← FDA ENFORCEMENT
Z-1940-2026Class II

Diversatek Healthcare

Recalling firm
Diversatek Healthcare
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
WI
Product quantity
250 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 Wire Guided Balloon Dilator, 15mm-16.5mm-18mm, REF 1205-18

Code / lot info

UDI/DI 00816734021798, Lot Numbers: 005985

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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.