- Recalling firm
- Diversatek Healthcare
- 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.
- Affected products (lot / model / serial)
- UDI/DI 00816734021804, Lot Numbers: 004947, 004950, 005311, 005397, 005484, 005574
- Units affected
- 1383 units
- Distribution pattern
- US: MO, CA, FL, TX, AZ, PA, RI, NC, IL, MS, KS, NY, OH, VA, LA, IA, MI, NJ, AL, Brazil, Belgium
- Firm location
- Milwaukee, WI, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-1941-2026
- Recall initiated
- March 18, 2026
- FDA classification date
- April 23, 2026
- FDA report date
- April 29, 2026
- FDA event ID
- 98649
- Last updated on HTM Vibe
- July 24, 2026