Recall archive / FDA device enforcement
Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 12mm-13.5mm-15mm, REF 1205-15 — FDA record Z-1939-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Mar 18, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 12mm-13.5mm-15mm, REF 1205-15
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Diversatek Healthcare
- Quantity
- 527 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1939-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI/DI 00816734021781, Lot Numbers: 004758, 005124, 005309, 005629 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US: MO, CA, FL, TX, AZ, PA, RI, NC, IL, MS, KS, NY, OH, VA, LA, IA, MI, NJ, AL, Brazil, Belgium
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Apr 29, 2026
- Recall initiation date
- Mar 18, 2026
- Center classification date
- Apr 23, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.