Diversatek Healthcare recalls Diversatek Healthcare Viper¿ 3-Stage Fixed Wire Balloon Dilator
- Recalling company
- Diversatek Healthcare
- Product
- Diversatek Healthcare Viper¿ 3-Stage Fixed Wire Balloon Dilator, 6mm-7mm-8mm, REF 1204-08
- 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 – may cause temporary or medically reversible health consequences
- Recall date
- Mar 18, 2026
- Reported
- Apr 29, 2026
- Distribution
- US: MO, CA, FL, TX, AZ, PA, RI, NC, IL, MS, KS, NY, OH, VA, LA, IA, MI, NJ, AL, Brazil, Belgium
- Status
- Ongoing
- Quantity
- 15 units
- Lot / codes
- UDI/DI 00816734021699, Lot Numbers: 005983
- Company location
- Milwaukee, WI
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-1938-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-1938-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.