FDA recall, , Moderate risk
Diversatek Healthcare Viper 3-Stage Fixed Wire and Wire Guided Balloon Dilator
The balloon dilator's inflation tag may list incorrect balloon sizes and pressures.
Summary by Recall Canary from the FDA notice
What happened
Diversatek Healthcare, based in Milwaukee, Wisconsin, recalled its Viper 3-Stage Wire Guided Balloon Dilator and Viper 3-Stage Fixed Wire Balloon Dilator because 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.
The recall began March 18, 2026, and was added to the FDA's Enforcement Report on April 23, 2026. The affected products include the 15mm-16.5mm-18mm, 18mm-19mm-20mm, and 12mm-13.5mm-15mm wire guided dilators, as well as the 6mm-7mm-8mm fixed wire dilator. The devices were distributed in the US and in Brazil and Belgium.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
4 products
Match the UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 15mm-16.5mm-18mm, REF 1205-18
- UDI-DI
- 00816734021798
- Lot code
- 005985
Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-20mm, REF 1205-20
- UDI-DI
- 00816734021804
- Lot code
- 004947
- 004950
- 005311
- 005397
- 005484
- 005574
Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 12mm-13.5mm-15mm, REF 1205-15
- UDI-DI
- 00816734021781
- Lot code
- 004758
- 005124
- 005309
- 005629
Diversatek Healthcare Viper¿ 3-Stage Fixed Wire Balloon Dilator, 6mm-7mm-8mm, REF 1204-08
- UDI-DI
- 00816734021699
- Lot code
- 005983
Recall details
- Company began the recall
- Sold in
US: Missouri, California, Florida, Texas, Arizona, Pennsylvania, Rhode Island, North Carolina, Illinois, Mississippi, Kansas, New York, Ohio, Virginia, Louisiana, Iowa, Michigan, New Jersey, Alabama, Brazil, Belgium
- Company
- Diversatek HealthcareMilwaukee, Wisconsin
- Hazard
- Labeling error
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98649
- Recall numbers
- Z-1938-2026 to Z-1941-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
