FDA Device recall Z-1939-2026
Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 12mm-13.5mm-15mm, REF 1205-15
- FDA Device
- Class II
- ongoing
- Published 2026-04-29
On 2026-04-29 the FDA classified a Class II recall of Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 12mm-13.5mm-15mm, REF 1205-15 by Diversatek Healthcare, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1939-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-03-18 |
| Published | 2026-04-29 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Diversatek Healthcare |
| Distribution | AL, AZ, CA, FL, IA, IL, KS, LA, MI, MO, MS, NC, NJ, NY, OH, PA, RI, TX, VA |
Product
Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 12mm-13.5mm-15mm, REF 1205-15
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.
Identifiers
| code_info | UDI/DI 00816734021781, Lot Numbers: 004758, 005124, 005309, 005629 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1939-2026%22
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