FDA Medical devices recall ·
Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator… recall
- Recall number
- Z-1941-2026
- Date
- (initiated March 18, 2026)
- Company / brand
- Diversatek Healthcare
102 E Keefe Ave, Milwaukee, WI, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1383 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-20mm, REF 1205-20
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI/DI 00816734021804, Lot Numbers: 004947, 004950, 005311, 005397, 005484, 005574
Distribution
US: MO, CA, FL, TX, AZ, PA, RI, NC, IL, MS, KS, NY, OH, VA, LA, IA, MI, NJ, AL, Brazil, Belgium
States: Alabama Arizona California Florida Iowa Illinois Kansas Louisiana Michigan Missouri Mississippi North Carolina New Jersey New York Ohio Pennsylvania Rhode Island Texas Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1941-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.