Diversatek Healthcare: Dilator, Esophageal
- Recalling firm
- Diversatek Healthcare
- Product
- Diversatek Healthcare Viper 3-Stage Wire Guided Balloon Dilator, 15mm-16.5mm-18mm, REF 1205-18
- 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
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-03-18
- Status
- Open, Classified
- Areas affected
- AL, AZ, CA, FL, IL, IA, KS, LA, MI, MS, MO, NJ, ...
- Distribution
- US: MO, CA, FL, TX, AZ, PA, RI, NC, IL, MS, KS, NY, OH, VA, LA, IA, MI, NJ, AL, Brazil, Belgium
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/0968cf1d-fbda-49e5-b66f-acdf51760bc5