FDAClass II · Medical device · Recall Z-1941-2026 · Recalled April 29, 2026
Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator recall — Diversatek Healthcare
Agency report date: April 29, 2026.
1. Compare your item
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
Agency product description and boundaries
Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-20mm, REF 1205-20
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
2. Agency hazard and consumer action
FDA reports: 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.
No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.
Class II: may cause temporary or medically reversible health consequences.
Affected product: Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator recall status
3. Open the official notice or contact
View the official FDA enforcement record (openFDA) ↗
Affected products
Companies & origin
Identifying details (verbatim from the notice)
Related recalls
Other medical device recalls from around the same time
- AIDBAGs are first aid kits of convenience composed of individually labeled devices designe recall — North American Rescue LLC.FDA · May 6, 2026
- WHILL Model F recall — WHILL, INC.FDA · May 6, 2026
- WHILL Model C2 recall — WHILL, INC.FDA · May 6, 2026
- Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as recall — Boston Scientific CorporationFDA · May 6, 2026
- Boston Scientific Pacemaker recall — Boston Scientific CorporationFDA · May 6, 2026
- CPSC — consumer products ↗ (aggregated here)
- NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
- FDA — food, drugs, medical devices ↗ (aggregated here)
- USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
- Recalls.gov — the U.S. government’s all-agency portal ↗
Found something wrong or missing? Report a data error.
Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 6:00 PM UTC. Record retrieved July 28, 2026 at 11:00 PM UTC.