Z-1940-2026 Class II Ongoing
FDA device recall Z-1940-2026 was initiated by Diversatek Healthcare on March 18, 2026 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 250 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 29, 2026
- Initiation Date
- March 18, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 250 units
Product Description
Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 15mm-16.5mm-18mm, REF 1205-18
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 Pattern
US: MO, CA, FL, TX, AZ, PA, RI, NC, IL, MS, KS, NY, OH, VA, LA, IA, MI, NJ, AL, Brazil, Belgium
Code Information
UDI/DI 00816734021798, Lot Numbers: 005985