Recall Z-1940-2026
Diversatek Healthcare · initiated March 18, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Diversatek Healthcare Viper 3-Stage Wire Guided Balloon Dilator, 15mm-16.5mm-18mm, REF 1205-18
Codes / lots: UDI/DI 00816734021798, Lot Numbers: 005985
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.
FDA-determined cause: Labeling Change Control
Action taken
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 lboll@diversatek.com 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 lboll@diversatek.com.
Details
- Recall number
- Z-1940-2026
- Initiated
- March 18, 2026
- Posted by FDA
- April 23, 2026
- Product code
- KNQ – Dilator, Esophageal
- Quantity
- 250 units
- Distribution
- US: MO, CA, FL, TX, AZ, PA, RI, NC, IL, MS, KS, NY, OH, VA, LA, IA, MI, NJ, AL, Brazil, Belgium
- Recalling firm
- Diversatek Healthcare, Milwaukee, WI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1938-2026 Class II | Diversatek Healthcare Viper 3-Stage Fixed Wire Balloon Dilator, 6mm-7mm-8mm, REF 1204-08The catheter inflation tag attached to the device may contain an incorrect part number with incorrect… | 03/18/2026Open, Classified |
| Z-1939-2026 Class II | Diversatek Healthcare Viper 3-Stage Wire Guided Balloon Dilator, 12mm-13.5mm-15mm, REF…The catheter inflation tag attached to the device may contain an incorrect part number with incorrect… | 03/18/2026Open, Classified |
| Z-1941-2026 Class II | Diversatek Healthcare Viper 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-20mm, REF…The catheter inflation tag attached to the device may contain an incorrect part number with incorrect… | 03/18/2026Open, Classified |