Viper recallZ-1938-2026 · Diversatek Healthcare · initiated Mar 18, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Diversatek Healthcare or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Labeling Change Control
What the company is doing
Diversatek Healthcare issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 3/18/2026 via USPS. The notice explained the problem, risk to health, and requested the consignee discard any affected product. Complete and return the attached MEDICAL DEVICE RECALL RETURN RESPONSE Acknowledgement and Receipt Form and provide Signature Confirming Customer Receipt to Laura Boll, VP Regulatory Affairs & Quality at [email protected] or 414-755-4806 to receive a replacement order. For questions about this issue, please contact Laura Boll, Vice President - Regulatory Affairs & Quality, at 414-755-4806 or [email protected].
Recall details
- Recall number
- Z-1938-2026
- Status
- Open, Classified
- Initiated by the company
- Mar 18, 2026
- Posted by the FDA
- Apr 23, 2026
- Recalling firm
- Diversatek Healthcare
- Quantity
- 15 units
- Product code
- KNQ
- Distribution
- US: MO, CA, FL, TX, AZ, PA, RI, NC, IL, MS, KS, NY, OH, VA, LA, IA, MI, NJ, AL, Brazil, Belgium
Product description
Diversatek Healthcare Viper 3-Stage Fixed Wire Balloon Dilator, 6mm-7mm-8mm, REF 1204-08
Code information (models, lots, serial numbers)
UDI/DI 00816734021699, Lot Numbers: 005983
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Viper 1204-08Diversatek Healthcare, Inc. · Dilator, Esophageal1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 98649).
- Z-1939-2026 · Open, ClassifiedDiversatek Healthcare Viper 3-Stage Wire Guided Balloon Dilator, 12mm-13.5mm-15mm, REF 1205-15
- Z-1940-2026 · Open, ClassifiedDiversatek Healthcare Viper 3-Stage Wire Guided Balloon Dilator, 15mm-16.5mm-18mm, REF 1205-18
- Z-1941-2026 · Open, ClassifiedDiversatek Healthcare Viper 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-20mm, REF 1205-20
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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