Quick Facts at a Glance
- Recall Date
- March 18, 2026
- Hazard Level
- HIGH
- Brand
- Diversatek Healthcare
- Geographic Scope
- Nationwide (50 states)
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Diversatek Healthcare
- Model numbers
- UDI/DI 00816734021781, Lot Numbers: 004758, 005124, 005309, 005629
- Where affected
- Nationwide
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
March 18, 2026
Reported by FDA DEVICE
April 29, 2026
RecallRadar source check
May 6, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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 You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Diversatek Healthcare or your healthcare provider for instructions. Notification method: Letter
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Full Description
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.. Classification: Class II. Quantity: 527 units. Distribution: US: MO, CA, FL, TX, AZ, PA, RI, NC, IL, MS, KS, NY, OH, VA, LA, IA, MI, NJ, AL, Brazil, Belgium
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: How to Get Refunds and ReplacementsWant to Know First?
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