Diversatek Healthcare Viper¿ 3-Stage Fixed Wire Balloon Dilator — Class II medical device recall Z-1938-2026
Ongoing recall by Diversatek Healthcare, reported 2026-04-29, distributed in AL, AZ, CA, FL, IA, IL, KS, LA…. The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon
| Recall number | Z-1938-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Diversatek Healthcare, Milwaukee, WI, United States |
| Recall initiated | 2026-03-18 |
| Classified | 2026-04-23 |
| Reported by FDA | 2026-04-29 |
| Distributed | AL, AZ, CA, FL, IA, IL, KS, LA, MI, MO, MS, NC, NJ, NY, OH, PA, RI, TX, VA |
| Countries outside the US | BE, BR |
| Quantity | 15 units |
| UPC / GTIN / UDI-DI | 00816734021699 |
| Lot numbers | 005983 |
| Model numbers | 1204-08 |
Product
Diversatek Healthcare Viper¿ 3-Stage Fixed Wire Balloon Dilator, 6mm-7mm-8mm, REF 1204-08
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1938-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.